A Research Study to See How Well Weekly Insulin Icodec Maintains Blood Sugar Levels Compared to Daily Basal Insulins in Adults with Type 2 Diabetes

2024-520068-32-00 Protocol NN1436-7727 Therapeutic use (Phase IV) Authorised, recruitment pending

Status Authorised, recruitment pending · 2 EU/EEA countries · 36 sites · Protocol NN1436-7727

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruitment pending
Participants planned 510
Countries 2
Sites 36

Type 2 diabetes

The primary objective is to evaluate the effectiveness on glycaemic control of once-weekly insulin icodec compared with once-daily basal insulin analogues at the discretion of the investigator, when used as intensification in participants with T2D on non-insulin glucose-lowering medication(s) in RW clinical practice. T…

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]
Decision date (initial)
2025-09-05
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No
Funding sources
Novo Nordisk A/S

External identifiers

EU CT number
2024-520068-32-00
WHO UTN
U1111-1302-4943

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

The primary objective is to evaluate the effectiveness on glycaemic control of once-weekly insulin icodec compared with once-daily basal insulin analogues at the discretion of the investigator, when used as intensification in participants with T2D on non-insulin glucose-lowering medication(s) in RW clinical practice. This includes comparing the difference in change from baseline in HbA1c between once-weekly insulin icodec and once-daily basal insulin analogues after 52 weeks of treatment to a non-inferiority limit of 0.3%.

Secondary objectives 1

  1. The secondary objective is to evaluate the effectiveness of once-weekly insulin icodec versus oncedaily basal insulin analogues at the discretion of the investigator, on self-reported treatment adherence, satisfaction, compliance and burden, and safety, when used as intensification in participants with T2D on non-insulin glucose-lowering medication(s) in RW clinical practice.

Conditions and MedDRA coding

Type 2 diabetes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Diagnosed with T2D ≥180 days prior to the day of screening.
  2. Treatment with any of the following non-insulin glucose-lowering medication(s) or combination regimen(s) at the time of screening: Metformin, Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs), Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists and Injectable dual glucose-dependent insulinotropic polypeptides (GIP) and GLP-1 receptor agonist.
  3. Need of intensification with basal insulin, as indicated at the discretion of the investigator.
  4. Recorded HbA1c value ≥7% within the last 90 days prior to randomisation.

Exclusion criteria 5

  1. Known or suspected hypersensitivity to study intervention(s) or related products.
  2. Previous participation in this study. Participation is defined as signed informed consent.
  3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method.
  4. Participation (i.e., received any study intervention) in any interventional clinical study within 90 days before screening.
  5. Any disorder which in the investigator’s opinion might jeopardise participant’s safety.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Change in HbA1c from baseline week 0 (V2) to week 52 (V6).

Secondary endpoints 7

  1. Adelphi Adherence Questionnaire (ADAQ©) At week 52 (V6).
  2. Change in DTSQs in total treatment satisfaction from baseline week 0 (V2) to week 52 (V6).
  3. TRIM-D compliance domain at week 52 (V6).
  4. TRIM-D treatment burden domain at week 52 (V6).
  5. Number of severe hypoglycaemic episodes (level 3) from baseline week 0 (V2) to week 52 (V6).
  6. Mean weekly basal insulin dose from week 50 to week 52 (V6).
  7. Participant achieved individualised HbA1c target at week 52 (V6).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 14

Awiqli 700 units/mL solution for injection in pre-filled pen

PRD11334596 · Product

Active substance
Insulin Icodec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE — INSULINS AND ANALOGUES, LONG-ACTING
Marketing authorisation
EU/1/24/1815/013
MA holder
NOVO NORDISK A/S
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Awiqli 700 units/mL solution for injection in pre-filled pen

PRD11334585 · Product

Active substance
Insulin Icodec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE — INSULINS AND ANALOGUES, LONG-ACTING
Marketing authorisation
EU/1/24/1815/002
MA holder
NOVO NORDISK A/S
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Awiqli 700 units/mL solution for injection in pre-filled pen

PRD11334594 · Product

Active substance
Insulin Icodec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE — INSULINS AND ANALOGUES, LONG-ACTING
Marketing authorisation
EU/1/24/1815/011
MA holder
NOVO NORDISK A/S
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Awiqli 700 units/mL solution for injection in pre-filled pen

PRD11334593 · Product

Active substance
Insulin Icodec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE — INSULINS AND ANALOGUES, LONG-ACTING
Marketing authorisation
EU/1/24/1815/010
MA holder
NOVO NORDISK A/S
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Awiqli 700 units/mL solution for injection in pre-filled pen

PRD11334588 · Product

Active substance
Insulin Icodec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE — INSULINS AND ANALOGUES, LONG-ACTING
Marketing authorisation
EU/1/24/1815/005
MA holder
NOVO NORDISK A/S
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Awiqli 700 units/mL solution for injection in pre-filled pen

PRD11334595 · Product

Active substance
Insulin Icodec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE — INSULINS AND ANALOGUES, LONG-ACTING
Marketing authorisation
EU/1/24/1815/012
MA holder
NOVO NORDISK A/S
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Awiqli 700 units/mL solution for injection in pre-filled pen

PRD11334592 · Product

Active substance
Insulin Icodec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE — INSULINS AND ANALOGUES, LONG-ACTING
Marketing authorisation
EU/1/24/1815/009
MA holder
NOVO NORDISK A/S
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Awiqli 700 units/mL solution for injection in pre-filled pen

PRD11334584 · Product

Active substance
Insulin Icodec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE — INSULINS AND ANALOGUES, LONG-ACTING
Marketing authorisation
EU/1/24/1815/001
MA holder
NOVO NORDISK A/S
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Awiqli 700 units/mL solution for injection in pre-filled pen

PRD11334587 · Product

Active substance
Insulin Icodec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE — INSULINS AND ANALOGUES, LONG-ACTING
Marketing authorisation
EU/1/24/1815/004
MA holder
NOVO NORDISK A/S
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Awiqli 700 units/mL solution for injection in pre-filled pen

PRD11334590 · Product

Active substance
Insulin Icodec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE — INSULINS AND ANALOGUES, LONG-ACTING
Marketing authorisation
EU/1/24/1815/007
MA holder
NOVO NORDISK A/S
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Awiqli 700 units/mL solution for injection in pre-filled pen

PRD11334597 · Product

Active substance
Insulin Icodec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE — INSULINS AND ANALOGUES, LONG-ACTING
Marketing authorisation
EU/1/24/1815/014
MA holder
NOVO NORDISK A/S
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Awiqli 700 units/mL solution for injection in pre-filled pen

PRD11334589 · Product

Active substance
Insulin Icodec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE — INSULINS AND ANALOGUES, LONG-ACTING
Marketing authorisation
EU/1/24/1815/006
MA holder
NOVO NORDISK A/S
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Awiqli 700 units/mL solution for injection in pre-filled pen

PRD11334591 · Product

Active substance
Insulin Icodec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE — INSULINS AND ANALOGUES, LONG-ACTING
Marketing authorisation
EU/1/24/1815/008
MA holder
NOVO NORDISK A/S
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Awiqli 700 units/mL solution for injection in pre-filled pen

PRD11334586 · Product

Active substance
Insulin Icodec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE — INSULINS AND ANALOGUES, LONG-ACTING
Marketing authorisation
EU/1/24/1815/003
MA holder
NOVO NORDISK A/S
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 52

Levemir FlexPen 100 units/ml solution for injection in pre-filled pen.

PRD3581963 · Product

Active substance
Insulin Detemir
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE05 — -
Marketing authorisation
EU/1/04/278/006
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Levemir Penfill 100 units/ml solution for injection in cartridge.

PRD3581952 · Product

Active substance
Insulin Detemir
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE05 — -
Marketing authorisation
EU/1/04/278/001
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Levemir FlexPen 100 units/ml solution for injection in pre-filled pen.

PRD3581965 · Product

Active substance
Insulin Detemir
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE05 — -
Marketing authorisation
EU/1/04/278/010
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Levemir FlexPen 100 units/ml solution for injection in pre-filled pen.

PRD3581958 · Product

Active substance
Insulin Detemir
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE05 — -
Marketing authorisation
EU/1/04/278/005
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Levemir Penfill 100 units/ml solution for injection in cartridge.

PRD3581951 · Product

Active substance
Insulin Detemir
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE05 — -
Marketing authorisation
EU/1/04/278/002
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Levemir Penfill 100 units/ml solution for injection in cartridge.

PRD3581950 · Product

Active substance
Insulin Detemir
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE05 — -
Marketing authorisation
EU/1/04/278/003
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Levemir FlexPen 100 units/ml solution for injection in pre-filled pen.

PRD3581964 · Product

Active substance
Insulin Detemir
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE05 — -
Marketing authorisation
EU/1/04/278/004
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Levemir FlexPen 100 units/ml solution for injection in pre-filled pen.

PRD3581959 · Product

Active substance
Insulin Detemir
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE05 — -
Marketing authorisation
EU/1/04/278/011
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen

PRD3585810 · Product

Active substance
Insulin Degludec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE06 — -
Marketing authorisation
EU/1/12/807/005
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen

PRD6429590 · Product

Active substance
Insulin Degludec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE06 — -
Marketing authorisation
EU/1/12/807/016
MA holder
NOVO NORDISK A/S
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen

PRD3585815 · Product

Active substance
Insulin Degludec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE06 — -
Marketing authorisation
EU/1/12/807/009
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresiba 100 units/mL Penfill solution for injection in cartridge

PRD3585806 · Product

Active substance
Insulin Degludec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE06 — -
Marketing authorisation
EU/1/12/807/008
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresiba 100 units/mL Penfill solution for injection in cartridge

PRD3585807 · Product

Active substance
Insulin Degludec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE06 — -
Marketing authorisation
EU/1/12/807/007
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen

PRD3585816 · Product

Active substance
Insulin Degludec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE06 — -
Marketing authorisation
EU/1/12/807/013
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen

PRD3585818 · Product

Active substance
Insulin Degludec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE06 — -
Marketing authorisation
EU/1/12/807/015
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen

PRD3585808 · Product

Active substance
Insulin Degludec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE06 — -
Marketing authorisation
EU/1/12/807/003
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen

PRD3585809 · Product

Active substance
Insulin Degludec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE06 — -
Marketing authorisation
EU/1/12/807/002
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen

PRD3585817 · Product

Active substance
Insulin Degludec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE06 — -
Marketing authorisation
EU/1/12/807/012
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen

PRD3585814 · Product

Active substance
Insulin Degludec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE06 — -
Marketing authorisation
EU/1/12/807/010
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen

PRD3585811 · Product

Active substance
Insulin Degludec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE06 — -
Marketing authorisation
EU/1/12/807/004
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen

PRD3585812 · Product

Active substance
Insulin Degludec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE06 — -
Marketing authorisation
EU/1/12/807/001
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen

PRD3585813 · Product

Active substance
Insulin Degludec
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE06 — -
Marketing authorisation
EU/1/12/807/006
MA holder
NOVO NORDISK A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus 100 units/ml solution for injection in a cartridge

PRD8585988 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/006
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus 100 units/ml solution for injection in a cartridge

PRD8585999 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/013
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus 100 units/ml solution for injection in a cartridge

PRD8585998 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/017
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus 100 units/ml solution for injection in a cartridge

PRD8585997 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/014
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus 100 units/ml solution for injection in a cartridge

PRD8585992 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/015
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen

PRD8586096 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/036
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus 100 units/ml solution for injection in a cartridge

PRD8585993 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/005
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen

PRD8586098 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/033
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen

PRD8586095 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/032
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen

PRD8586097 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/034
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus 100 units/ml solution for injection in a cartridge

PRD8586000 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/007
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus 100 units/ml solution for injection in a cartridge

PRD8586001 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/016
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen

PRD8586090 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/037
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus 100 units/ml solution for injection in a vial

PRD8586139 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/001
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen

PRD8586088 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/030
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus 100 units/ml solution for injection in a vial

PRD8586138 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE, A10AE04 — INSULINS AND ANALOGUES, LONG-ACTING, INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/012
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus 100 units/ml solution for injection in a vial

PRD8586141 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/002
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus 100 units/ml solution for injection in a vial

PRD8586140 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/003
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus 100 units/ml solution for injection in a vial

PRD8586137 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/004
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen

PRD8586091 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/031
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen

PRD8586099 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/134/035
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen

PRD8572990 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/133/035
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen

PRD8573008 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/133/037
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen

PRD8573002 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/133/036
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen

PRD8573005 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/133/039
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen

PRD8573006 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/133/033
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen

PRD8573001 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/133/041
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen

PRD8572991 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/133/034
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen

PRD8572998 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/133/040
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen

PRD8572996 · Product

Active substance
Insulin Glargine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0 U unit(s)
Max total dose
0 U unit(s)
Max treatment duration
54 Week(s)
Authorisation status
Authorised
ATC code
A10AE04 — INSULIN GLARGINE
Marketing authorisation
EU/1/00/133/038
MA holder
SANOFI-AVENTIS DEUTSCHLAND GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novo Nordisk A/S

107 Total trials 29 Recruiting 72 Ended
Commercial
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 4

OrganisationCity, countryDuties
Oracle Danmark ApS
ORG-100044663
 Hellerup, Denmark Other
Q Squared Solutions Limited
ORG-100042527
 Reading, United Kingdom Laboratory analysis
4G Clinical B.V.
ORG-100044721
 Amsterdam, Netherlands Other
Oracle America Inc.
ORG-100039874
 Redwood City, United States Other

Locations

2 EU/EEA countries · 36 investigational sites

By country

CountryMS statusPlanned subjectsSites
Germany Authorised, recruitment pending 130 23
Italy Authorised, recruitment pending 74 13
Rest of world
Canada
 — 306 —

Investigational sites

Germany

23 sites · Authorised, recruitment pending
Praxis Dr. Astrid Schmidt-Reinwald
NA, Paulinstraße 9-11, 54292, Trier
Praxis Dr. Stephan Scharla
NA, Salinenstr. 8, 83435, Bad Reichenhall
Institut für Diabetesforschung Osnabrück
NA, Blumenhaller Weg 11, 49080, Osnabrück
Versdias GmbH
Diabetologikum Amberg-Sulzbach, Marienstrasse 9, 92224, Amberg
Diabetes-Zentrum-Wilhelmsburg GbR
NA, Krieterstrasse 30, Wilhelmsburg, Hamburg
Studiengesellschaft Drs Könemann / Steinmann
Wilhelmstraße 25-27, Wilhelmstraße 25, 32257, Bünde
Praxis am Markt Dr. Becker
NA, Weidkamp 1, 45355, Essen
Diabetologische Schwerpunktpraxis Daaden
NA, Diabetische Schwerpunktpraxis Daaden, Betzdorfer Straße 59, Daaden
MVZ Hausärzte Großenbaum GmbH
NA, Großenbaumer Allee 113, 47269, Duisburg
Studienzentrum Dr. Faulmann GbR
NA, Loewenhainer Strasse 36, Tolkewitz/seidnitz-Nord, Dresden
Gesundheitsverbund Landkreis Konstanz gGmbH
Hegau-Bodensee-Klinikum Singen GmbH, Studienzentrum Hegau-Bodensee, Virchowstrasse 10, 78224, Singen (Hohentwiel)
Centrum Fuer Diabetologie Und Allgemeinmedizin
ceda, Haus 4, Neue Mitte 10, Pohlheim
MVZ im Altstadt-Carree Fulda GmbH
Zentrum für klinische Studien, Dalbergstrasse 22, Innenstadt, Fulda
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR
Schwerpunktpraxis Dres. Klaus Busch und Christian Busch/Christoph Cramer, Kampstrasse 45, Mitte, Dortmund
MVZ DiaMedicum Bad Mergentheim GmbH
Diabetespraxis Bad Mergentheim, Theodor-Klotzbuecher-Strasse 12, 97980, Bad Mergentheim
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
NA, Galenstrasse 3, Spandau, Berlin
Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach
NA, Clemdastrasse 1, 99817, Eisenach
Praxis Am Oberen Tor
Praxis Dr. Simon-Wagner, Kronacher Strasse 1, 96215, Lichtenfels
Mesut Durmaz Schwerpunktpraxis für Diabetes, Hormone & Stoffwechsel Studienzentrum
NA, August-Mohl-Straße 37, 95030, Hof
Diabeteszentrum Ludwigsburg
NA, Diabeteszentrum Ludwigsburg, Marktplatz 7, Ludwigsburg
Praxisgemeinschaft Jerichow Schulze
NA, Johannes-Lange-Str. 20, 39319, Jerichow
Familienmedizinisches Zentrum Radowsky
FMZ Radowsky - Studienzentrum, Luetzner Str. 145, 04179, Leipzig
MVZ Contilia GmbH - Studienzentrum Diabetologie
NA, Hauptstr. 54, 45219, Essen

Italy

13 sites · Authorised, recruitment pending
Azienda Ospedaliero Universitaria Renato Dulbecco
N/A, Viale Europa, 88100, Catanzaro
Azienda Ospedaliero-Universitaria Policlinico Umberto I
N/A, Viale Del Policlinico 155, 00161, Rome
University Of Bari Aldo Moro
N/A, Piazzale Giulio Cesare 11, 70124, Bari
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
N/A, Via Del Vespro 129, 90127, Palermo
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
N/A, Largo Francesco Vito 1, 00168, Rome
ASST Fatebenefratelli Sacco
N/A, Via Giovanni Battista Grassi 74, 20157, Milan
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
N/A, Piazza Luigi Miraglia 2, 80138, Naples
Azienda Sanitaria Territoriale Di Fermo
N/A, Via Dante Zeppilli 18, 63900, Fermo
Hospital Santa Maria Della Misericordia
N/A, Piazzale Giorgio Menghini 1, 06129, Perugia
Azienda Ospedaliera Universitaria Gaetano Martino Messina
N/A, Via Consolare Valeria N 1, 98124, Messina
Universita' Degli Studi G. D'Annunzio Di Chieti
N/A, Via Luigi Polacchi 11, 66100, Chieti Scalo
Azienda Unita Sanitaria Locale Della Romagna
N/A, Via Alcide De Gasperi 8, 48121, Ravenna
Azienda Ospedaliero Universitaria Careggi
N/A, Largo Giovanni Alessandro Brambilla 3, 50134, Florence

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 23 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) d1_nn1436-7727-protocol-2024-520068-32-eng_for-publication 2
Protocol (for publication) D4_DE-NN1436-7727-Paper PRO Questionnaire-Cover Letter-German-For Publication 1
Protocol (for publication) D4_DE-NN1436-7727-Paper PRO Questionnaire-End Text-German-For Publication 1
Protocol (for publication) D4_IT-NN1436-7727-Paper PRO Questionnaire-Cover Letter-Italian-For Publication 1
Protocol (for publication) D4_IT-NN1436-7727-Paper PRO Questionnaire-End Text-Italian-For Publication 1
Protocol (for publication) D4_NN1436-7727-Paper PRO Questionnaire-ADAQ-ENG-For Publication 1
Protocol (for publication) D4_NN1436-7727-Paper PRO Questionnaire-Cover Letter-ENG-For Publication 1
Protocol (for publication) D4_NN1436-7727-Paper PRO Questionnaire-DTSQ-ENG-For Publication 1
Protocol (for publication) D4_NN1436-7727-Paper PRO Questionnaire-End Text-ENG-For Publication 1
Protocol (for publication) D4_NN1436-7727-Paper PRO Questionnaire-TRIM-D-ENG-For Publication 1
Recruitment arrangements (for publication) K1_DE_NN1436-7727 Recruitment and Informed consent procedure_English 1
Recruitment arrangements (for publication) k1_it_nn1436-7727-recruitment-arrangements-english_for-publication 1
Recruitment arrangements (for publication) k2_de_nn1436-7727-recruitment-material-ipp-app-participant-support-guide-german_for-publication 1.0
Recruitment arrangements (for publication) k2_de_nn1436-7727-recruitment-material-ipp-app-patient-onboarding-instructions-de_for-publication 1.0
Subject information and informed consent form (for publication) l1_de-nn1436-7727-piic-adult-main-german_for-publication 4
Subject information and informed consent form (for publication) l1_de-nn1436-7727-piic-male-partner-german_for-publication 3
Subject information and informed consent form (for publication) l1_de-nn1436-7727-piic-pregnancy-female-german_for-publication 2
Subject information and informed consent form (for publication) l1_it-nn1436-7727-piic-main-adult_for-publication 2.0
Subject information and informed consent form (for publication) l1_it-nn1436-7727-piic-male-partner-_for-publication 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC-Lantus 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC-Toujeo 1
Synopsis of the protocol (for publication) D1_IT-NN1436-7727 Protocol Synopsis-EU CT 2024-520068-32-For Publication 1
Synopsis of the protocol (for publication) D1_NN1436-7727 Protocol Synopsis-EU CT 2024-520068-32-For Publication 1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-05-22 Germany Acceptable
2025-09-04
 2025-09-05
2 SUBSTANTIAL MODIFICATION SM-1 2026-01-16 Germany Acceptable
2026-03-02
 2026-03-02

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