A research study comparing how well different doses of the medicine NNC0487-0111 lower blood sugar in people with type 2 diabetes

Overview

Sponsor-declared trial summary

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

26 Jul 2024 → 25 Oct 2025

Decision date (initial)

2024-07-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2023-509412-28-00

WHO UTN

U1111-1296-9708

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Dose response, Efficacy

To demonstrate and characterise the dose response relationship of QW s.c. NNC0487-0111, and to compare the effect of varying doses to placebo, for change in HbA1c from baseline to week 36 in participants with T2D inadequately controlled with metformin +/- SGLT2 inhibitor.

To demonstrate and characterise the dose response relationship of QD oral NNC0487-0111, and to compare the effect of varying doses to placebo, for change in HbA1c from baseline to week 36 in participants with T2D inadequately controlled with metformin +/- SGLT2 inhibitor.

Secondary objectives 4

1. To characterise the dose-response relationship of varying doses of QW s.c. NNC0487-0111, and compare the effect of varying doses to placebo, for relative change in body weight from baseline to week 36 in participants with T2D inadequately controlled with metformin +/- SGLT2 inhibitor. To characterise the dose-response relationship of varying doses of QD oral NNC0487-0111, and compare the effect of varying doses to placebo, for relative change in body weight from baseline to week 36 in participants with T2D inadequately controlled with metformin +/- SGLT2 inhibitor.
2. To compare the effect of varying doses of QW s.c. NNC0487-0111 versus placebo in participants with T2D inadequately controlled with metformin +/- SGLT2 inhibitor, on: body weight, glycaemic control, BMI, waist circumference, blood pressure, inflammation lipid metabolism. To compare the effect of varying doses of QD oral NNC0487-0111 versus placebo in participants with T2D inadequately controlled with metformin +/- SGLT2 inhibitor, on: body weight, glycaemic control, BMI, waist circumference, blood pressure, inflammation, lipid metabolism.
3. To compare the safety and tolerability of varying doses of QW s.c. NNC0487-0111 versus placebo in participants with T2D inadequately controlled with metformin +/- SGLT2 inhibitor. To compare the safety and tolerability of varying doses of QD oral NNC0487-0111 versus placebo in participants with T2D inadequately controlled with metformin +/- SGLT2 inhibitor.
4. To compare the effect of varying doses of QW s.c. NNC0487-0111 versus placebo in participants with T2D inadequately controlled with metformin +/- SGLT2 inhibitor, on chronic kidney disease (CKD) markers. To compare the effect of varying doses of QD oral NNC0487-0111 versus placebo in participants with T2D inadequately controlled with metformin +/- SGLT2 inhibitor, on chronic kidney disease (CKD) markers.

Conditions and MedDRA coding

Type 2 Diabetes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Male or female, aged 18-75 years (both inclusive) at the time of signing the informed consent.
2. Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
3. Stable daily dose(s) ≥ 90 days before screening 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 inhibitor.
4. HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening.
5. Body mass index between ≥ 23.0 and <50.0 kg/m2.
6. Able and willing to adhere to the protocol including wearing a continuous glucose monitoring (CGM) device provided for the study, as judged by the investigator.

Exclusion criteria 3

1. 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.
2. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus 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.
3. Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question4.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in HbA1c

Secondary endpoints 17

1. Relative change in body weight
2. Change in body weight
3. Change in fasting plasma glucose (FPG)
4. CGM: Change in time in range (TIR) 3.9–10.0 mmol/L (70–180 mg/dL)
5. Change in body mass index (BMI)
6. Change in waist circumference
7. Change in systolic blood pressure (SBP)
8. Change in average 24 hour systolic blood pressure (SBP)
9. Change in high sensitivity C-Reactive Protein (hsCRP)
10. Change in total cholesterol
11. Change in high-density lipoprotein (HDL) cholesterol
12. Change in low-density lipoprotein (LDL) cholesterol
13. Change in triglycerides
14. Number of adverse events
15. Change in Urinary Albumin/Creatinine Ratio (UACR)
16. Participant without macroalbuminuria (UACR < 300 mg/g) at baseline (week 0) developing (yes/no) new onset of macroalbuminuria (UACR ≥ 300 mg/g)
17. Change in eGFR creatinine-cystatin C based CKD-EPI

Investigational products

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

Test 8

Placebo 2

Auxiliary 2

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 12

Locations

9 EU/EEA countries · 59 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 72 files

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

Application history

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