A Research Study to See How Switching from a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults 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

12 Apr 2024 → 14 Jun 2025

Decision date (initial)

2024-03-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2023-506084-34-00

WHO UTN

U1111-1292-6151

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To demonstrate the effect on glycaemic control of once-weekly insulin icodec, switched unit-to-unit from a daily basal insulin, with or without non-insulin anti-diabetic drugs, in participants with T2D treated with basal insulin. This includes comparing the difference in change from baseline in HbA1c between insulin icodec and insulin glargine U100 after 26 weeks of treatment to a non-inferiority margin of 0.3%-point.

Secondary objectives 1

1. To compare parameters of glycaemic control, patient-reported outcomes and safety of once-weekly insulin icodec, switched unit-to-unit from a daily basal insulin, compared to once-daily insulin glargine U100, both treatment arms with or without non-insulin anti-diabetic drugs, in participants with T2D treated with basal insulin.

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. HbA1c from 7.0-10.0% (53.0‑85.8 mmol/mol), both inclusive, at screening confirmed by central laboratory analysis.
3. Treated with once-daily or twice-daily basal insulin (Neutral Protamine Hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 U/mL, or insulin glargine 300 U/mL) ≥ 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses ≥ 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), DPP-4 inhibitors, SGLT2 inhibitors, thiazolidinediones, alpha-glucosidase inhibitors, oral combination products (for the allowed individual oral anti-diabetic drugs), oral or injectable GLP-1 RAs, Injectable GLP-1/GIP RA combination products
4. Body mass index (BMI) ≤ 40.0 kg/m2.

Exclusion criteria 5

1. Any episodes of diabetic ketoacidosis within 90 days prior to the day of screening.
2. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
3. Chronic heart failure classified as being in New York Heart Association Class IV at screening.
4. Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids).
5. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to 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

1. Change in HbA1c from baseline week 0 (V6) to week 26 (V32)

Secondary endpoints 9

1. Change in time in range 3.9–10.0 mmol/L (70–180 mg/dL)
2. Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction
3. Number of severe hypoglycaemic episodes (level 3) (safety)
4. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) (safety)
5. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
6. Time spent < 3.0 mmol/L (54 mg/dL)
7. Change in time spent > 10.0 mmol/L (180 mg/dL)
8. Mean weekly insulin dose
9. Change in body weight

Investigational products

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

Test 1

Comparator 1

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 5

Locations

4 EU/EEA countries · 24 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 50 files

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

Application history

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