Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
2,728
Countries
15
Sites
140
Type 2 diabetes
To confirm superiority of CagriSema 00 mg/00 mg versus semaglutide 00 mg on change in HbA1c in participants with T2D in inadequate glycaemic control on stable dose of metformin +/-SGLT2i
Key facts
- Sponsor
- Novo Nordisk A/S
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 7 Nov 2023 → 6 Jan 2026
- Decision date (initial)
- 2023-11-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502678-18-00
- WHO UTN
- U1111-1283-0427
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To confirm superiority of CagriSema 00 mg/00 mg versus semaglutide 00 mg on change in HbA1c in participants with T2D in inadequate glycaemic control on stable dose of metformin +/-SGLT2i
Secondary objectives 17
- To confirm superiority of CagriSema 00 mg/00 mg versus cagrilintide 00 mg on change in HbA1c
- To confirm superiority of CagriSema 00 mg/00 mg versus semaglutide 00 mg on change in body weight
- To confirm superiority of cagrilintide 00 mg versus placebo on change in: HbA1c, body weight
- To confirm superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg) on: Achievement of ≥ 10% weight reduction, Achievement of ≥ 15% weight reduction, Achievement of ≥ 20% weight reduction
- To confirm superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively) on time in tight range (TITR)
- To confirm superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively) on: Systolic blood pressure, Triglycerides, Non-HDL cholesterol
- To confirm superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively) on time in range (TIR)
- To confirm superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively) on hsCRP
- To compare the effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively) on: Other parameters of glycaemic control, Achievement of ≥ 5 % weight reduction, Waist circumference, Diastolic blood pressure, Lipids, Clinical outcome assessments
- To compare the safety and tolerability of CagriSema (00 mg/00 mg and 00 mg/00 mg) versus semaglutide (00 mg and 00 mg), placebo and cagrilintide 00 mg
- To compare the effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively) on: Renal biomarkers, Inflammation, Other parameters of glycaemic control, Leptin and soluble leptin receptor, Clinical outcome assessments
- To confirm superiority of CagriSema 00 mg/00 mg versus cagrilintide 00 mg on change in body weight
- To confirm superiority of CagriSema 00 mg/00 mg versus semaglutide 00 mg on change in HbA1c
- To confirm superiority of CagriSema 00 mg/00 mg versus semaglutide 00 mg on change in body weight
- To confirm superiority of CagriSema 00 mg/00 mg versus semaglutide 00 mg on change in HbA1c
- To confirm superiority of CagriSema 00 mg/00 mg versus semaglutide 00 mg on change in body weight
- To confirm superiority of CagriSema (pooled doses) versus semaglutide (pooled doses) on time in range (TIR)
Conditions and MedDRA coding
Type 2 diabetes
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10045242 | Type II diabetes mellitus | 10027433 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Male or female (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
- Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
- Stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without SGLT2 inhibitors.
- HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
- BMI ≥ 25 kg/m2 at screening. BMI will be calculated in the eCRF based on height and body weight at screening.
Exclusion criteria 3
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 m2 as determined by central laboratory at screening.
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change in HbA1c from baseline (week 0) to end of treatment (week 68)
Secondary endpoints 35
- Superiority of CagriSema 00 mg/00 mg versus cagrilintide 00 mg: Change in HbA1c from baseline (week 0) to end of treatment (week 68)
- Superiority of CagriSema 00 mg/00 mg versus cagrilintide 00 mg: Relative change in body weight from baseline (week 0) to end of treatment (week 68)
- Superiority of CagriSema 00 mg/00 mg versus semaglutide 00 mg: Change in HbA1c from baseline (week 0) to end of treatment (week 68)
- Superiority of CagriSema 00 mg/00 mg versus semaglutide 00 mg: Relative change in body weight from baseline (week 0) to end of treatment (week 68)
- Superiority of cagrilintide 00 mg versus placebo: Change in HbA1c from baseline (week 0) to end of treatment (week 68)
- Superiority of cagrilintide 00 mg versus placebo: Relative change in body weight from baseline (week 0) to end of treatment (week 68)
- Superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg): Achievement of ≥ 10 % weight reduction from baseline (week 0) to end of treatment (week 68)
- Superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg): Achievement of ≥ 15 % weight reduction From baseline (week 0) to end of treatment (week 68)
- Superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg): Achievement of ≥ 20 % weight reduction From baseline (week 0) to end of treatment (week 68)
- Superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): CGM: Change in time in tight target range (TITR) 3.9–7.8 mmol/L (70–140 mg/dL) From baseline (week -3 to end of treatment (week 68)
- Superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Change in systolic blood pressure (SBP) from baseline (week 0) to end of treatment (week 68)
- Superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Ratio to baseline in triglycerides from baseline (week 0) to end of treatment (week 68)
- Superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Ratio to baseline in non-HDL cholesterols from baseline (week 0) to end of treatment (week 68)
- Superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): CGM: Change in time in range (TIR) 3.9–10.0 mmol/L (70–180 mg/dL) from baseline (week -3) to end of treatment (week 68)
- Superiority of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Ratio to baseline in high sensitivity C-reactive protein (hsCRP) from baseline (week 0) to end of treatment (week 68)
- Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Change in Fasting Plasma Glucose (FPG) From baseline (week 0) to end of treatment (week 68)
- Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Achievement of HbA1c target values of <7.0% (<53 mmol/mol) at end of treatment (week 68)
- Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Achievement of HbA1c target values of ≤6.5% (≤48 mmol/mol) at end of treatment (week 68)
- Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): CGM: Change in Time above range, >10.0 mmol/L (>180 mg/dL) from baseline (week -3) to end of treatment (week 68)
- Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): CGM: Change in Time above range, >13.9 mmol/L (>250 mg/dL) from baseline (week -3) to end of treatment (week 68)
- Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): CGM: Within-day glycaemic variability (% CV) at end of treatment (week 68)
- Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Achievement of ≥ 5 % weight reduction from baseline (week 0) to end of treatment (week 68)
- Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Change in waist circumference from baseline (week 0) to end of treatment (week 68)
- Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Change in diastolic blood pressure (DBP) from baseline (week 0) to end of treatment (week 68)
- Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Ratio to baseline in lipids: Total cholesterol, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, Very low-density lipoprotein (VLDL) cholesterol, Free fatty acids from baseline (week 0) to end of treatment (week 68)
- Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Change in SF-36v2 score: Physical Component Summary score, Mental Component Summary score from baseline (week 0) to end of treatment (week 68)
- Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score from baseline (week 0) to end of treatment (week 68)
- Effect of CagriSema versus semaglutide (00 mg/00 mg versus 00 mg and 00 mg/00 mg vs 00 mg, respectively): Change in Treatment Related Impact Measure for Diabetes (TRIM-D) score from baseline (week 0) to end of treatment (week 68)
- Safety and tolerability of CagriSema (00 mg/00 mg and 00 mg/00 mg) versus semaglutide (00 mg and 00 mg), placebo and cagrilintide 00 mg: Number of Treatment Emergent Adverse Events (TEAEs) from baseline (week 0) to end of study (week 75)
- Safety and tolerability of CagriSema (00 mg/00 mg and 00 mg/00 mg) versus semaglutide (00 mg and 00 mg), placebo and cagrilintide 00 mg: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) from baseline (week 0) to end of study (week 75)
- Safety and tolerability of CagriSema (00 mg/00 mg and 00 mg/00 mg) versus semaglutide (00 mg and 00 mg), placebo and cagrilintide 00 mg: Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold from baseline (week 0) to end of study (week 75)
- Superiority of CagriSema 00 mg/00 mg versus semaglutide 00 mg: Relative change in body weight from baseline (week 0) to end of treatment (week 68)
- Superiority of CagriSema 00 mg/00 mg versus semaglutide 00: Change in HbA1c
- Superiority of CagriSema 00 mg/00 mg versus semaglutide 00 mg: Relative change in body weight
- Superiority of CagriSema (pooled doses) versus semaglutide (pooled doses): CGM: Change in time in range (TIR) 3.9–10.0 mmol/L (70–180 mg/dL) from baseline (week -3) to end of treatment (week 68)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
PRD8977530 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977527 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977531 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977529 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977528 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 10
PRD8977521 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977517 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977519 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977520 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977518 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977522 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977526 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977524 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977525 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977523 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 2
SCP153586 · ATC
- Active substance
- Dapagliflozin
- Route of administration
- ORAL
- Max daily dose
- 00
- Max total dose
- 00
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BK01 — DAPAGLIFLOZIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP135808 · ATC
- Active substance
- Metformin
- Substance synonyms
- DIMETHYLDIGUANIDE
- Route of administration
- ORAL
- Max daily dose
- 00
- Max total dose
- 00
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BA02 — METFORMIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novo Nordisk A/S
- Sponsor organisation
- Novo Nordisk A/S
- Address
- Novo Alle 1
- City
- Bagsvaerd
- Postcode
- 2880
- Country
- Denmark
Scientific contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU Submission Hub
Public contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU Submission Hub
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| SYRINX Bioanalytics Oy ORG-100021026
|
Turku, Finland | Laboratory analysis |
| Celerion Inc. ORG-100029202
|
Lincoln, United States | Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| 4G Clinical B.V. ORG-100044721
|
Amsterdam, Netherlands | Other |
| Abbott GmbH ORG-100000219
|
Wiesbaden, Germany | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Affidea Piraeus Biopathological ORG-100047597
|
Pireas, Greece | Other |
| Accellacare Limited ORG-100044508
|
Dublin 18, Ireland | Other |
| Iqvia Limited ORG-100008655
|
Reading, United Kingdom | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Laboratory analysis |
| Oracle America Inc. ORG-100039874
|
Redwood City, United States | Other |
Locations
15 EU/EEA countries · 140 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 100 | 8 |
| Croatia | Ended | 66 | 6 |
| Czechia | Ended | 65 | 7 |
| Denmark | Ended | 29 | 6 |
| Finland | Ended | 24 | 5 |
| Germany | Ended | 104 | 15 |
| Greece | Ended | 142 | 11 |
| Hungary | Ended | 116 | 9 |
| Italy | Ended | 101 | 13 |
| Poland | Ended | 153 | 16 |
| Romania | Ended | 124 | 13 |
| Slovakia | Ended | 90 | 10 |
| Slovenia | Ended | 35 | 7 |
| Spain | Ended | 57 | 7 |
| Sweden | Ended | 17 | 7 |
| Rest of world
Japan, Argentina, Australia, South Africa, China, Israel, Korea, Republic of, Turkey, India, United Kingdom, United States, Canada, Brazil, Taiwan, Serbia
|
— | 1,505 | — |
Investigational sites
Medical Center Maria Med EOOD
N/A, Bulevard Sveti Kliment Ohridski 3a, 1756, Sofiya
Medical Center Zdrave Lom EOOD
N/A, Ulitsa Panayot Volov 6, 3600, Lom
Diagnostic Consultative Centre Ascendent OOD
Endocrinology and Metabolic Diseases Consulting Room, Ul.bacho Kiro 47, 1202, Sofia
Dr. Tatyana Metalova Ambulatoria Za Individualna Praktika Za Spetsializirana Meditsinska EOOD
N/A, Stara Planina 54, Floor 2 Room 23, Gotse Delchev
Razgrad Medical Center Ltd.
N/A, Ulitsa Vasil Levski 1, 7200, Razgrad
Medcenter Nova Clinic Ltd.
N/A, Ulitsa Vyara 7, 9020, Varna
Individual Practice For Specialized Medical Care Dr. Nikolay Kostadinov EOOD
N/A, Zornitsa Bl 50 En 2 Canibet 7, 8000, Burgas
MBAL Sveta Marina EAD
Clinic of Endocrinology and Metabolic Diseases, Hristo Smirnenski Str 1, 9010, Varna
Poliklinika SLAVONIJA OSIJEK za opcu kirurgiju radiologiju baromedicinu ginekologiju i porodiljstvo i internu medicinu
N/A, Josipa Jurja Strossmayera 163, 31000, Osijek
Opca Bolnica Varazdin
N/A, Ulica Ivana Mestrovica 1, 42000, Varazdin
Thalassotherapia Specijalna bolnica za medicinsku rehabilitaciju bolesti srca pluca i reumatizma
N/A, Marsala Tita 188/1, 51410, Opatija
Clinical Hospital Centre Rijeka
N/A, Kresimirova 42, 51000, Rijeka
General Hospital Dr. Josip Bencevic
N/A, Ulica Dr. Andrije Stampara 42, 35000, Slavonski Brod
Poliklinika Solmed d.o.o.
N/A, Preradoviceva Ulica 20, Zagreb, Grad Zagreb
Diabet2 s.r.o.
N/A, Revolucni 765/19, Stare Mesto, Prague 1
Fakultni Nemocnice U Sv Anny V Brne
N/A, Pekarska 53, Stare Brno, Brno-Stred
Institut Klinicke A Experimentalni Mediciny
N/A, Videnska 1958, Krc, Prague 4
Dialine s.r.o.
N/A, Tylova 502/39, Jizni Predmesti, Plzen 3
Diahaza s.r.o.
N/A, Palackeho 492/62, 769 01, Holesov
MUDr. Michala Pelikanova s.r.o.
N/A, Hudeckova 1043/10, Podoli, Prague 4
Edumed s.r.o.
N/A, Smetanova 91, 550 01, Broumov
Steno Diabetes Center Copenhagen
N/A, Borgmester Ib Juuls Vej 83, 2730, Herlev
Bispebjerg Hospital
Bispebjerg Hospital, IC Forskning, Indgang 11B, stuen, Nielsine Nielsens vej 6B, 2400, Copenhagen N, Bispebjerg Hospital, IC-Forskning, Copenhagen
Hvidovre Hospital
N/A, Kettegaard Alle 30, 2650, Hvidovre
Nordsjaellands Hospital
N/A, Dyrehavevej 29, 3400, Hilleroed
Odense University Hospital
N/A, Kloevervaenget 6/3, 5000, Odense C
Aarhus Universitetshospital
Steno Diabetes Center Aarhus, Indgang A, Krydspunkt A 305, Palle Juul-Jensens Boulevard 11, 8200, Aarhus Universitetshospital, Palle Juul-Jensens Boulevard 11, Aarhus
Suomen Terveystalo Oy
N/A, Rautatienkatu 27, 33100, Tampere
Turku University Hospital
N/A, Kiinamyllynkatu 4-8, 20520, Turku
Etela-Pohjanmaan Sairaanhoitopiiri
N/A, Hanneksenrinne 7, 60220, Seinajoki
Suomen Terveystalo Oy
N/A, Vainonkatu 9, 40100, Jyvaskyla
Pihlajalinna Laeaekaerikeskukset Oy
N/A, Hatanpaan Valtatie 1, 33100, Tampere
Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
N/A, Praxis Dr. med. Staudenmeyer, Am Wall Süd 20, Lingen
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR
N/A, Kampstrasse 45, Mitte, Dortmund
University Of Luebeck
N/A, Ratzeburger Allee 160, Strecknitz, Lübeck
Diabetes-Zentrum-Wilhelmsburg GbR
N/A, Krieterstrasse 30, Wilhelmsburg, Hamburg
Bag Diabeteszentrum Dr. Tews & Partner
N/A, 4 Obergeschoss, Herzbachweg 14e, Gelnhausen
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
N/A, Markt 15, 23758, Oldenburg In Holstein
Praxis Fuer Innere Medizin
N/A, Weinhold-Arkade 4, 04442, Zwenkau
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
N/A, Galenstrasse 3, Spandau, Berlin
Innodiab Forschung GmbH
N/A, Eleonorastrasse 42, Ruettenscheid, Essen
Diabetologische Schwerpunktpraxis Daaden
N/A, Diabetische Schwerpunktpraxis Daaden, Betzdorfer Straße 59, Daaden
Diabetes Zentrum Wandsbek Diabetologische Schwerpunktpraxis Berufsausuebungsgemeinschaft GbR
N/A, Wandsbeker Marktstrasse 73, Wandsbek, Hamburg
Technische Universitat Dresden
N/A, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Die Praxis am Ludwigsplatz
N/A, Gemeinschaftspraxis, Dr. med. Kempe / Dr. med. Stemler, Ludwigshafen
Medicover Neuroendokrinologie MVZ
N/A, Orleansplatz 3, 81667, Muenchen
Zentrum fuer klinische Studien Suedbrandenburg GmbH
N/A, Bahnhofstrasse 22, 04910, Elsterwerda
General Hospital Of Thessaloniki Papageorgiou
3rd Department of Internal Medicine, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
Athens Medical Center S.A.
Diabetes and Obesity Unit, Distomou 5-7, 151 25, Maroussi
General University Hospital Of Larissa
Department of Endocrinology, P. O. Box 1425, 411 10, Larissa
Athens Medical Center S.A.
Department of Internal Medicine and Diabetes, Adersen 1, 115 25, Athens
Hippokration Hospital
2nd Propaedeutic Department in Internal Medicine, Konstadinoupoleos 49, 546 42, Thessaloniki
University General Hospital Of Thessaloniki Ahepa
1st Propaedeutic Department of Internal Medicine, 1st St Kiriakidis Str, 546 36, Thessaloniki
Euromedica General Clinic Of Thessaloniki
Department of Endocrinology, Diabetes and Metabolism, Kallas Marias 11, Gravias 2, Thessaloniki
Laiko General Hospital Of Athens
1st Propaedeutic Clinic of Internal Medicine, Agiou Thoma (goudi) 17, 115 27, Athens
General Hospital Of Athens G Gennimatas
Department of Endocrinology, Messogion Avenue 154, 115 27, Athens
University General Hospital Of Thessaloniki Ahepa
Department of Endocrinology - Diabetes, 1st St Kiriakidis Str, 546 36, Thessaloniki
University General Hospital Attikon
2nd Department of internal medicine, Research Institute and Diabetes Center, Rimini Street 1, 124 62, Athens
University Of Szeged
N/A, Kalvaria Sugarut 57, 6725, Szeged
Zala Megyei Szent Rafael Korhaz
N/A, Zrinyi Miklos Utca 1, 8900, Zalaegerszeg
Central Hospital Of Northern Pest Military Hospital
N/A, Robert Karoly Korut 44, 1134, Budapest XIII
Somogy Varmegyei Kaposi Mor Oktato Korhaz
N/A, Tallian Gyula Utca 20-32, 7400, Kaposvar
University Teaching Hospital Markusovszky
N/A, Markusovszky Str. 5, 9700, Szombathely
Obudai Egeszsegugyi Centrum Kft.
N/A, Lajos Utca 74-76, 1036, Budapest III
Kanizsai Dorottya Korhaz
N/A, Szekeres Jozsef Utca 2-8, 8800, Nagykanizsa
University Of Debrecen
N/A, Nagyerdei Korut 98, 4032, Debrecen
Bajcsy-Zsilinszky Korhaz Es Rendelointezet
N/A, Maglodi Ut 89-91, Kerulet, Budapest
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
N/A, Via Del Vespro 129, 90127, Palermo
Azienda Ospedaliera Universitaria Integrata Verona
N/A, Piazzale Aristide Stefani 1, 37126, Verona
Azienda Ospedaliero-Universitaria Renato Dulbecco
N/A, Viale Europa – Germaneto, 88100, Catanzaro
Azienda Sanitaria Usl Toscana Sud Est
N/A, Ospedale Area Aretina Nord, Via Pietro Nenni 20/22, Arezzo
Ospedale San Raffaele S.r.l.
N/A, Via Olgettina 60, 20132, Milan
Azienda Ospedaliera Universitaria Federico II Di Napoli
N/A, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
N/A, Via Del Vespro 129, 90127, Palermo
Azienda Ospedaliera Papa Giovanni XXIII
N/A, Piazza Oms 1, 24127, Bergamo
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
N/A, Largo Francesco Vito 1, 00168, Rome
Careggi University Hospital
N/A, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospealiero Universitaria Policlinico Umberto I
N/A, Viale Del Policlinico 155, 00161, Rome
Universita' Degli Studi G. D'annunzio Di Chieti
N/A, Via Dei Vestini 31, 66100, Chieti
ASST Fatebenefratelli Sacco
N/A, Via Giovanni Battista Grassi 74, 20157, Milan
American Heart Of Poland S.A.
N/A, Ul. Edukacji 102, 43-100, Tychy
Instytut Diabetologii Sp. z o.o.
N/A, Ul. Raclawicka 129/2u, 02-117, Warsaw
Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno Diabetologiczny
N/A, Ul. Ludwika Zamenhofa 10/20, 15-435, Bialystok
Velocity Nova Sp. z o.o.
N/A, Ul. 11 Listopada 78, 28-200, Staszow
American Heart Of Poland S.A.
N/A, Ul. Parzeczewska 35, 95-100, Zgierz
Centrum Medyczne Medyk Sp. z o.o.
N/A, Ul. Fryderyka Szopena 1, 35-055, Rzeszow
Pratia S.A.
N/A, Ul. Wojciecha Lochowskiego 7a, 85-796, Bydgoszcz
American Heart Of Poland S.A.
N/A, Ul. Szpitalna 13, 41-300, Dabrowa Gornicza
NBR Polska Tomasz Klodawski
N/A, Aleja Wincentego Witosa 31, 00-710, Warsaw
NZOZ Osteo-Medic S.C
N/A, ul. Wiejska 81, 15-351, Białystok
Prywatna Praktyka Lekarska Anna Chudoba
N/A, ul. M. Kopernika 31, 96300, Żyrardów
Velocity Nova Sp. z o.o.
N/A, Ul. Kazimierza Przerwy-Tetmajera 21, 20-362, Lublin
American Heart Of Poland S.A.
N/A, Ul. Topolowa 16, 32-500, Chrzanow
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
N/A, Ul. Pabianicka 62, 93-513, Lodz
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
N/A, Ul. Woloska 137, 02-507, Warsaw
Specjalistyczny Gabinet Diabetologiczny Radosław Rumianowski
N/A, ul. Szarych Szeregów 38, Poland, Gorzów Wielkopolski
Urodiamed S.R.L.
N/A, Bulevardul Chitu Gheorghe Nr 35, 200349, Craiova
Diabmed Dr. Popescu Alexandrina S.R.L.
N/A, Strada Transilvaniei Nr.20, 100179, Ploiesti
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti
N/A, Strada Movila Ion 5-7, 020475, Bucharest
Sc Cmi Dr. Pletea Noemi S.R.L.
N/A, Strada Stadionului Nr 3a Parter, 600154, Bacau
Cabinet Medical de Diabet, Nutritie si Boli Metabolice-Dr. Zaharie Daniela Gabriela
N/A, Str. Dumbrava, Nr. 43, Zalau
Mariodiab Clinic S.R.L.
N/A, Block 75 Scara A, Bulevardul 15 Noiembrie Nr 75, Brasov
Milena Sante S.R.L.
N/A, Strada Balcescu Nicolae Nr 31, 800001, Galati
Bella Praxis S.R.L.
N/A, Aleea Tineretului Nr 4, 705200, Pascani
Poli Cardinal Med S.R.L.
N/A, Strada Cardinal Alexandru Todea Nr. 22, 545300, Reghin
CMI Dr. Busegeanu Mihaela Magdalena
N/A, Alexandru Odobescu, nr. 30, Ploiesti
Diabet Med S.R.L.
N/A, Calea Rahovei No 322d, 050913, Bucharest
Spitalul Clinic Judetean De Urgenta Cluj
N/A, Strada Clinicilor 2, 400006, Cluj-Napoca
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
N/A, Strada Crisului Nr. 1, 500283, Brasov
Diada s.r.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Panska 17, Dlha Luka, Bardejov
Diacentrum s.r.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Mostova 26, 034 01, Ruzomberok
Dioli s.r.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Narodna Trieda 27, Sever, Kosice - Sever
Dialipid s.r.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Reimanova 4, 080 01, Presov
Areteus s.r.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, M. R. Stefanika 25a/3782, 075 01, Trebisov
iDia s.r.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Hviezdoslavova 383/14, 968 01, Nova Bana
DEImedi s. r. o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Juraja Holceka 39/25, 941 44, Hul
MUDr. Jan Culak s.r.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Nabrezna Ulica 5, 971 01, Prievidza
Medi-Dia s.r.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Namestie Slobody 65, 083 01, Sabinov
MediVet s.r.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Jana Holleho 1672/24, 901 01, Malacky
Univerzitetni Klinicni Center Maribor
N/A, Ljubljanska Ulica 5, 2000, Maribor
Dermatologija Bartenjev
N/A, Finzgarjeva ulica 4, 1000, Ljubljana
ZDRAVSTVENI DOM Osnovno varstvo Nova Gorica
N/A, Rejceva Ulica 4, 5000, Nova Gorica
SPLOSNA BOLNISNICA DR. FRANCA DERGANCA Nova Gorica
N/A, Ulica Padlih Borcev 13/a, 5290, Sempeter Pri Gorici
Bolnisnica Topolsica
N/A, Topolsica 64, 3326, Topolsica
Zdravstveni dom Koper
N/A, Dellavallejeva ulica 3, 6000, Koper
ZD Kocevje
N/A, Roska Cesta 18, 1330, Kocevje
Hospital Universitario de Móstoles
N/A, Calle doctor Luis Montes S/N, Servicio de Endocrinología Planta principal, consultas externas, Móstoles
Complexo Hospitalario Universitario A Coruna
N/A, Lugar Jubias De Arriba 84, 15006, A Coruna
Vall D'hebron Institut De Recerca
N/A, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
Hospital Universitario Y Politecnico La Fe
N/A, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Projectes Sanitaris I Socials S.A.
N/A, Plaza Era S/n, 08430, La Roca Del Valles
Hospital General De Segovia
N/A, Calle De Luis Erik Claveria, 40002, Segovia
Hospital Quironsalud Infanta Luisa
N/A, Calle De San Jacinto 87, 41010, Sevilla
Kalthus Heart & Horse AB
Clemenstorgets hjärtmottagning, S Domkyrkofors., Clemenstorget 5, Lund
Karolinska University Hospital
FoU Tema Hjärta Kärl,Eugeniavägen 27,Karolinska Universitetssjukhuset Solna,171 76 Stockholm, Eugeniavagen 3, 171 64, Solna
Region Oerebro Laen
Överviktsenheten, Medicinkliniken, Universitetssjukhuset, 701 85 Örebro, Sodra Grev Rosengatan, 701 85, Orebro
CTC Clinical Trial Consultants AB
CTC GoCo Möndal, Vetenskapens Graend 11, 431 53, Moelndal
Region Skane Skanes Universitetssjukhus
Endokrinmottagning Lund, Skånes universitetssjukhus, Lasarettsgatan 15, 221 85 Lund, Entregatan 7, Lunds Allhelgonafors, Lund
CTC Clinical Trial Consultants AB
CTC EbbePark Linköping, Ebbegatan 3, 582 13, Linkoping
Region Skane Skanes Universitetssjukhus
Forskningsmottagning Internmedicin, Inga Marie Nilssons gata 22, 205 02 Malmö, St. Johns, Fritz Bauers Gata 5, Malmo
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Bulgaria | 2023-11-09 | 2025-12-08 | 2023-11-15 | 2024-06-28 | |
| Croatia | 2023-11-07 | 2025-12-02 | 2023-11-08 | 2024-06-04 | |
| Czechia | 2023-11-13 | 2025-12-05 | 2023-11-24 | 2024-06-28 | |
| Denmark | 2024-01-22 | 2025-12-18 | 2024-02-23 | 2024-07-18 | |
| Finland | 2024-02-15 | 2025-12-23 | 2024-02-19 | 2024-07-18 | |
| Germany | 2023-11-07 | 2025-12-29 | 2023-11-08 | 2024-07-08 | |
| Greece | 2023-11-14 | 2025-12-17 | 2023-11-15 | 2024-07-17 | |
| Hungary | 2023-11-10 | 2025-11-24 | 2023-11-21 | 2024-06-24 | |
| Italy | 2023-12-07 | 2025-12-29 | 2023-12-18 | 2024-07-24 | |
| Poland | 2023-11-10 | 2025-12-05 | 2023-11-14 | 2024-07-01 | |
| Romania | 2023-11-08 | 2025-12-04 | 2023-11-15 | 2024-06-19 | |
| Slovakia | 2023-11-09 | 2025-12-03 | 2023-11-15 | 2024-06-26 | |
| Slovenia | 2023-12-01 | 2025-12-01 | 2023-12-11 | 2024-06-17 | |
| Spain | 2023-11-15 | 2025-12-12 | 2023-11-21 | 2024-07-04 | |
| Sweden | 2024-01-12 | 2025-12-15 | 2024-02-26 | 2024-06-28 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Serious breaches 2 · Art. 52 CTR
Serious breach SB-102750
- Sponsor became aware
- 2025-10-13
- Date of breach
- 2025-08-25
- Submission date
- 2025-11-13
- Member states concerned
- Bulgaria, Croatia, Czechia, Denmark, Finland, Germany, Greece, Hungary, Italy, Romania, Slovenia, Spain, Sweden, Poland, Slovakia
- Categories
- Protocol
- Areas impacted
- Data reliability or robustness
- Benefit-risk balance changed
- No
- Description
- Central laboratory reports containing comments from third-party laboratory could unblind the treatment arm were shared with the sponsor Global Trial Management team who subsequently distributed to Clinical Development Centre Trial Managers (CDC-TM) and Clinical Research Associates (CRA) unaware of the unblinding information being included. The number of CDC-TMs and/or CRAs who have accessed the laboratory reports is currently unknown and still under investigation for assessing actual impact and data reliability and/or robustness.
The member state most affected is Denmark. - Sponsor actions
- Copies of the central laboratory reports containing unblinding information have been deleted from Novo Nordisk trial team repositories. The weekly central laboratory reports were updated and all unblinding information was excluded
Implementation of quality control measures at the central laboratory to identify unblinding information prior to distributing unblinded information to blinded Novo Nordisk trial team is ongoing.
| Organisation | City | Country | Type |
|---|---|---|---|
| Icon Clinical Research Limited | Dublin 18 | Ireland | Analytical and Clinical laboratory |
Serious breach SB-73664
- Sponsor became aware
- 2025-02-28
- Date of breach
- 2024-08-29
- Submission date
- 2025-03-07
- Member states concerned
- Bulgaria, Croatia, Czechia, Denmark, Finland, Germany, Greece, Hungary, Italy, Romania, Slovenia, Spain, Sweden, Poland, Slovakia
- Categories
- Protocol
- Areas impacted
- Subject rights
- Benefit-risk balance changed
- No
- Description
- Non-Compliance at two sites in United Kingdom.
A Substantial Amendment and an updated Informed Consent on safety updates was submitted and approved, and relevant sites were informed.
The Clinical Research Associate responsible (CRA) for the two mentioned sites was on long-term sick leave. As a result, the training on and implementation of the substantial amendment and reconsent of trial participants was delayed. - Sponsor actions
- Both sites have now been trained on the updated safety information. The two sites will inform all their trial participants of the updated safety information and obtain re-consent at the participants' next on-site visit.
A follow-up CRA monitoring visit will be scheduled as per the monitoring plan to ensure re-consent has been obtained and accurately documented at both sites. Additionally, a robust tracking system for substantial amendments will be implemented to ensure that all substantial amendments are promptly executed and documented at all trial sites.
| Organisation | City | Country | Type |
|---|---|---|---|
| Ninewells Hospital | Dundee | United Kingdom | Clinical investigator |
| Aberdeen Royal Infirmary | Aberdeen | United Kingdom | Clinical investigator |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 145 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_NN9388-4896- Document not in scope of publication- Approval of Protocol Statement | 1.0 |
| Protocol (for publication) | d1_nn9388-4896-protocol-2022-502678-18-english_for-publication | 4 |
| Protocol (for publication) | d1_nn9388-4896-protocol-2022-502678-18-greek_for-publication | 4 |
| Protocol (for publication) | D4_NN9388-4896 - Subject Questionnaire SPFQ-DE-for publication | 2 |
| Protocol (for publication) | D4_NN9388-4896 - Subject Questionnaire TRIM-D-DE-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896 - Subject Questionnaire TRIM-D-ENG-master version-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896 - Subject Questionnaire TRIM-D-ES-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896 - Subject Questionnaire TRIM-D-GR-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896 - Subject Questionnaire TRIM-D-HR-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896 - Subject Questionnaire TRIM-D-HU-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896 - Subject Questionnaire TRIM-D-IT-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896 - Subject Questionnaire TRIM-D-RO-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896 - Subject Questionnaire TRIM-D-SE-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896 - Subject Questionnaire TRIM-D-SI-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896_Subject Diary- Low blood sugar episode-DE-for publication | 2 |
| Protocol (for publication) | D4_NN9388-4896_Subject Diary- Low blood sugar episode-EN-master version-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896_Subject Diary- Low blood sugar episode-ES-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896_Subject Diary- Low blood sugar episode-GR-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896_Subject Diary- Low blood sugar episode-HR-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896_Subject Diary- Low blood sugar episode-HU-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896_Subject Diary- Low blood sugar episode-IT-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896_Subject Diary- Low blood sugar episode-RO-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896_Subject Diary- Low blood sugar episode-SE-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896_Subject Diary- Low blood sugar episode-SI-for publication | 1.0 |
| Protocol (for publication) | D4_NN9388-4896_Subject Diary-Low blood sugar episode-SK-For Publication | 1 |
| Protocol (for publication) | D4_NN9388-4896_Subject Questionnaire PGIS_DE_For publication | 1 |
| Protocol (for publication) | D4_NN9388-4896_Subject Questionnaire TRIM-D-SK-For Publication | 1 |
| Protocol (for publication) | D4_NN9388-4896_Subject Questionnaire-CoEQ-DE_For publication | 1 |
| Protocol (for publication) | D4_NN9388-4896_Subject Questionnaire-PGIC-DE_For publication | 1 |
| Protocol (for publication) | d4_nn9388-4896-patient-facing-material-with-copyright-english_for-publication | 1 |
| Recruitment arrangements (for publication) | K1 HR-NN9388-4896-Recruitment Arrangements and Procedure-for publication | 1 |
| Recruitment arrangements (for publication) | K1_BG NN9388-4896- Recruitment and Informed Consent procedure- For Publication | 1 |
| Recruitment arrangements (for publication) | K1_CZ-NN9388-4896-Recruitment Arrangements and Procedure-for publication | 1 |
| Recruitment arrangements (for publication) | K1_DE NN9388-4896- Recruitment and Informed Consent procedure- For Publication | 1 |
| Recruitment arrangements (for publication) | K1_ES NN9388-4896-Recruitment and Informed Consent Procedure-For publication | 1 |
| Recruitment arrangements (for publication) | K1_GR NN9388-4896- Recruitment and Informed Consent procedure- For Publication | 1 |
| Recruitment arrangements (for publication) | K1_HU NN9388-4896-Recruitment and Informed Consent Procedure-For Publication | 1 |
| Recruitment arrangements (for publication) | K1_IT NN9388-4896-Recruitment and Informed Consent Procedure-For publication | 1 |
| Recruitment arrangements (for publication) | K1_NN9388-4896 DK Recruitment informed consent procedure - For publication | 2 |
| Recruitment arrangements (for publication) | K1_NN9388-4896 FI Recruitment and informed consent procedure - For publication | 1 |
| Recruitment arrangements (for publication) | K1_NN9388-4896 SE Recruitment and informed consent procedure - For publication | 1 |
| Recruitment arrangements (for publication) | K1_PL NN9388-4896- Informed consent patient recruitment procedure- Polish- For publication | 3 |
| Recruitment arrangements (for publication) | K1_PL NN9388-4896-Recruitment and Informed Consent Procedure-For publication | 1.0 |
| Recruitment arrangements (for publication) | K1_RO NN9388-4896 Recruitment and Informed consent procedure-For Publication | 1 |
| Recruitment arrangements (for publication) | K1_SI NN9388-4896 Recruitment and Informed consent procedure-For Publication | 2 |
| Recruitment arrangements (for publication) | K1_SK NN9388-4896 Recruitment and Informed consent procedure-For Publication | 1 |
| Recruitment arrangements (for publication) | K2 HR-NN9388-4896-Patient Recruitment advertisement-poster-for publication | 1 |
| Recruitment arrangements (for publication) | K2_BG NN9388-4896- Recruitment material- Poster- For Publication | 1 |
| Recruitment arrangements (for publication) | K2_CZ-NN9388-4896-Patient Recruitment advertisement-poster-for publication | 1 |
| Recruitment arrangements (for publication) | K2_DE NN9388-4896- Recruitment material- Call Guide- For publication | 5 |
| Recruitment arrangements (for publication) | K2_DE NN9388-4896- Recruitment material- Overview of Digital Recruitment campaign- For publication | 1 |
| Recruitment arrangements (for publication) | K2_DE NN9388-4896- Recruitment material- Poster- For Publication | 3 |
| Recruitment arrangements (for publication) | K2_DE NN9388-4896- Recruitment material- Social Media Content Assets- For publication | 3 |
| Recruitment arrangements (for publication) | K2_DE NN9388-4896-Recruitment material-Website pages and prescreener flow-Part 1-For publication | 3 |
| Recruitment arrangements (for publication) | K2_DE NN9388-4896-Recruitment material-Website pages and prescreener flow-Part 2-For publication | 3 |
| Recruitment arrangements (for publication) | k2_dk_nn9388-4896-recruitment-material-welcome-booklet-danish_for-publication | 2 |
| Recruitment arrangements (for publication) | K2_ES NN9388-4896-Patient Recruitment Advertisement-Poster-For publication | 1 |
| Recruitment arrangements (for publication) | K2_GR NN9388-4896- Recruitment material- Poster- For Publication | 1 |
| Recruitment arrangements (for publication) | K2_HU NN9388-4896-Patient Recruitment Advertisement-Poster-For Publication | 2 |
| Recruitment arrangements (for publication) | K2_IT NN9388-4896-Recruitment Advertisement-Call Guide-For publication | 2.0 |
| Recruitment arrangements (for publication) | K2_IT NN9388-4896-Recruitment Advertisement-Digital Recruitment Campaign-For publication | 1 |
| Recruitment arrangements (for publication) | K2_IT NN9388-4896-Recruitment Advertisement-Poster-For publication | 1 |
| Recruitment arrangements (for publication) | K2_IT NN9388-4896-Recruitment Advertisement-Pre Screener Flow-For publication_2 of 3 | 2.0 |
| Recruitment arrangements (for publication) | K2_IT NN9388-4896-Recruitment Advertisement-Pre Screener Flow-For publication_3 of 3 | 2.0 |
| Recruitment arrangements (for publication) | K2_IT NN9388-4896-Recruitment Advertisement-Social Media Content Assets-For publication | 2.0 |
| Recruitment arrangements (for publication) | k2_it_nn9388-4896-recruitment-material-website-pages-and-pre-screener-flow-italian-_for-publication | 2 |
| Recruitment arrangements (for publication) | K2_NN9388-4896 DK Poster - For publication | 1 |
| Recruitment arrangements (for publication) | K2_NN9388-4896 DK Recruitment Advertisement Material_For publication | 1 |
| Recruitment arrangements (for publication) | K2_NN9388-4896 DK Recruitment material-Advertisement Text_For publication | 3 |
| Recruitment arrangements (for publication) | K2_NN9388-4896 FI Recruitment poster - For publication | 1 |
| Recruitment arrangements (for publication) | K2_NN9388-4896 SE Recruitment Poster - For publication | 1 |
| Recruitment arrangements (for publication) | K2_PL NN9388-4896-Patient Recruitment Advertisement-Recruitment Poster-Polish-For publication | 1.0 |
| Recruitment arrangements (for publication) | K2_RO NN9388-4896 Recruitment material Advertisement Poster-For Publication | 1 |
| Recruitment arrangements (for publication) | K2_SI NN9388-4896 Recruitment material Advertisement Poster-For Publication | 1 |
| Recruitment arrangements (for publication) | K2_SK NN9388-4896 Recruitment material Advertisement Poster-For Publication | 1 |
| Subject information and informed consent form (for publication) | L1 CZ-NN9388-4896 PIIC_ Male partner for enrolled patients-For publication | 3 |
| Subject information and informed consent form (for publication) | L1 CZ-NN9388-4896 SIS-ICF Future Research-for publication | 2 |
| Subject information and informed consent form (for publication) | L1 CZ-NN9388-4896 SIS-ICF Male Partner-for publication | 3 |
| Subject information and informed consent form (for publication) | L1 HR-NN9388-4896 SIS-ICF Future Research-for publication | 2 |
| Subject information and informed consent form (for publication) | L1 HR-NN9388-4896 SIS-ICF Male-for publication | 3 |
| Subject information and informed consent form (for publication) | L1 HR-NN9388-4896 SIS-ICF Pregnant Subject-for publication | 1 |
| Subject information and informed consent form (for publication) | L1_BG NN9388-4896- SI-IC- Future research- For publication | 2 |
| Subject information and informed consent form (for publication) | L1_BG NN9388-4896- SI-IC- Main- English_For publication | 4.0 |
| Subject information and informed consent form (for publication) | L1_BG NN9388-4896- SI-IC- Male partner- For publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_BG_NN9388-4896 SI-IC_Male Partner_English_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | l1_bg-nn9388-4896-piic-main-_for-publication | 6 |
| Subject information and informed consent form (for publication) | l1_cz-nn9388-4896-piic-adult-_for-publication | 4 |
| Subject information and informed consent form (for publication) | l1_cz-nn9388-4896-piic-adult-for-enrolled-_for-publication | 4 |
| Subject information and informed consent form (for publication) | L1_DE NN9388-4896- SI-IC- Bring your own device- For publication | 3 |
| Subject information and informed consent form (for publication) | L1_DE NN9388-4896- SI-IC- Future research- For publication | 4 |
| Subject information and informed consent form (for publication) | L1_DE NN9388-4896- SI-IC- Male partner- For publication | 4 |
| Subject information and informed consent form (for publication) | l1_de-nn9388-4896-piic-adult-_for-publication | 7 |
| Subject information and informed consent form (for publication) | l1_dk-nn9388-4896-piic-main-_for-publication | 4 |
| Subject information and informed consent form (for publication) | L1_ES NN9388-4896-SI IC-Future Research-For publication | 2 |
| Subject information and informed consent form (for publication) | L1_ES NN9388-4896-SI IC-Male Partner-For publication | 3.0 |
| Subject information and informed consent form (for publication) | l1_es-nn9388-4896-piic-adult-_for-publication | 4 |
| Subject information and informed consent form (for publication) | l1_fi-nn9388-4896-piic-adult-_for-publication | 7 |
| Subject information and informed consent form (for publication) | L1_GR NN9388-4896- SI-IC- Future- For publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_GR NN9388-4896- SI-IC- Male- For publication | 2.0 |
| Subject information and informed consent form (for publication) | l1_gr-nn9388-4896-piic-adult-_for-publication | 4 |
| Subject information and informed consent form (for publication) | l1_hr-nn9388-4896-piic-adult-_for-publication | 3 |
| Subject information and informed consent form (for publication) | L1_HU NN9388-4896 SI-IC-Future Research-For Publication | 2 |
| Subject information and informed consent form (for publication) | L1_HU NN9388-4896 SI-IC-Male Partner-For Publication | 4.0 |
| Subject information and informed consent form (for publication) | l1_hu-nn9388-4896-piic-adult-_for-publication | 7 |
| Subject information and informed consent form (for publication) | L1_IT NN9388-4896-SI IC-Future Research-For publication | 1 |
| Subject information and informed consent form (for publication) | L1_IT NN9388-4896-SI IC-Male Partner-For publication | 2.0 |
| Subject information and informed consent form (for publication) | l1_it-nn9388-4896-piic-adult-_for-publication | 3 |
| Subject information and informed consent form (for publication) | L1_NN9388-4896 DK SI-IC Male - For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_NN9388-4896 FI SI-IC male partner - For publication | 3 |
| Subject information and informed consent form (for publication) | L1_NN9388-4896 SE SI-IC future - For publication | 2 |
| Subject information and informed consent form (for publication) | L1_NN9388-4896 SE SI-IC male - For publication | 2 |
| Subject information and informed consent form (for publication) | L1_PL NN9388-4896 SI-IC-Male Partner-For publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_PL NN9388-4896- SI-IC- Future research- For publication | 2.0 |
| Subject information and informed consent form (for publication) | l1_pl-nn9388-4896-piic-adult-_for-publication | 4 |
| Subject information and informed consent form (for publication) | L1_RO NN9388-4896 SI-IC Male Partner - For publication | 2 |
| Subject information and informed consent form (for publication) | L1_RO NN9388-4896 SI-IC Future Research - For publication | 1 |
| Subject information and informed consent form (for publication) | l1_ro-nn9388-4896-piic-main-_for-publication | 3 |
| Subject information and informed consent form (for publication) | l1_se-nn9388-4896-piic-adult-_for-publication | 3 |
| Subject information and informed consent form (for publication) | L1_SI NN9388-4896 SI-IC Future Research - For publication | 1 |
| Subject information and informed consent form (for publication) | L1_SI NN9388-4896 SI-IC Male - For publication | SI-02 |
| Subject information and informed consent form (for publication) | l1_si-nn9388-4896-piic-adult-_for-publication | SI-04 |
| Subject information and informed consent form (for publication) | L1_SK NN9388-4896 SI-IC Data Protection- For publication | 2 |
| Subject information and informed consent form (for publication) | L1_SK NN9388-4896 SI-IC Future Research - For publication | 1 |
| Subject information and informed consent form (for publication) | L1_SK NN9388-4896 SI-IC Male Partner- For publication | 2 |
| Subject information and informed consent form (for publication) | l1_sk-nn9388-4896-piic-adult-_for-publication | 4 |
| Subject information and informed consent form (for publication) | L2_DE NN9388-4896- Document not in scope for publication | 1 |
| Subject information and informed consent form (for publication) | L2_DE NN9388-4896- Other subject information-Subject Questionnaire_SPFQ_For publication | 3 |
| Subject information and informed consent form (for publication) | L2_HU NN9388-4896-Subject ID Card-For Publication | 2 |
| Subject information and informed consent form (for publication) | L2_IT NN9388-4896-Info Privacy Form-Future Research-For publication | 1 |
| Subject information and informed consent form (for publication) | L2_IT NN9388-4896-Info Privacy Form-Main Adult-For publication | 1 |
| Subject information and informed consent form (for publication) | L2_IT NN9388-4896-Info Privacy Form-Male Partner-For publication | 1 |
| Subject information and informed consent form (for publication) | L2_NN9388-4896 DK Dine rettigheder som forsgsperson i forsg med medicin - For publication | 4 |
| Synopsis of the protocol (for publication) | d1_bg_nn9388-4896-protocol-synopsis-2022-502678-18-bulgarian-_for-publication | 2.0 |
| Synopsis of the protocol (for publication) | d1_cz_nn9388-4896-protocol-synopsis-2022-502678-18-czech-_for-publication | 2 |
| Synopsis of the protocol (for publication) | d1_cz_nn9388-4896-protocol-synopsis-expert-2022-502678-18-czech-_for-publication | 1 |
| Synopsis of the protocol (for publication) | d1_es_nn9388-4896-protocol-synopsis-2022-502678-18-spanish-_for-publication | 2 |
| Synopsis of the protocol (for publication) | d1_gr_nn9388-4896-protocol-synopsis-2022-502678-18-greek-_for-publication | 2 |
| Synopsis of the protocol (for publication) | d1_hu_nn9388-4896-protocol-synopsis-2022-502678-18-hungarian-_for-publication | 2 |
| Synopsis of the protocol (for publication) | d1_it_nn9388-4896-protocol-synopsis-2022-502678-18-italian-_for-publication | 2 |
| Synopsis of the protocol (for publication) | d1_nn9388-4896-protocol-synopsis-2022-502678-18-english_for-publication | 2 |
| Synopsis of the protocol (for publication) | d1_pl_nn9388-4896-protocol-synopsis-2022-502678-18-polish-_for-publication | 2 |
| Synopsis of the protocol (for publication) | d1_ro_nn9388-4896-protocol-synopsis-2022-502678-18-romanian-_for-publication | 2 |
| Synopsis of the protocol (for publication) | d1_se_nn9388-4896-protocol-synopsis-2022-502678-18-swedish-_for-publication | 2 |
| Synopsis of the protocol (for publication) | d1_si_nn9388-4896-protocol-synopsis-2022-502678-18-slovenian-_for-publication | 2 |
| Synopsis of the protocol (for publication) | d1_sk_nn9388-4896-protocol-synopsis-2022-502678-18-slovakian-_for-publication | 2 |
Application history
18 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-03 | Denmark | Acceptable with conditions 2023-10-30
|
2023-10-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-11-29 | Acceptable with conditions 2023-10-30
|
2023-11-29 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-01-05 | Acceptable with conditions 2023-10-30
|
2024-01-05 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-09 | Acceptable with conditions | 2024-02-08 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-12 | Denmark | Acceptable with conditions | 2024-01-22 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-01-16 | Acceptable with conditions | 2024-03-15 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-01-19 | Acceptable with conditions | 2024-03-04 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-01-23 | Acceptable with conditions | 2024-03-11 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-01-25 | Acceptable with conditions | 2024-03-11 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-01-30 | Acceptable with conditions | 2024-02-21 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-04-16 | Denmark | Acceptable with conditions | 2024-04-16 |
| 12 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-05-20 | Denmark | Acceptable 2024-06-26
|
2024-06-26 |
| 13 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-09-17 | Denmark | Acceptable 2024-12-11
|
2024-12-12 |
| 14 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-02-11 | Denmark | Acceptable 2025-04-10
|
2025-04-11 |
| 15 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-05-29 | Denmark | Acceptable | 2025-06-04 |
| 16 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-08-22 | Denmark | Acceptable 2025-10-22
|
2025-10-22 |
| 17 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-11-26 | Acceptable | 2026-01-16 | |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-01-28 | Denmark | Acceptable | 2026-01-28 |