A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination with Insulin Aspart, in Adults with Type 1 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

21 Aug 2025 → ongoing

Decision date (initial)

2025-08-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2024-519945-31-00

WHO UTN

U1111-1310-7017

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 in combination with insulin aspart in individuals with T1D. This includes comparing the difference in change from baseline in HbA1c between once-weekly insulin icodec and once-daily insulin glargine , both in combination with insulin aspart, after 26 weeks of treatment to a non-inferiority limit of 0.3%.

Secondary objectives 1

1. To compare parameters of glycaemic control, safety and patient-reported outcomes of once-weekly insulin icodec compared to once-daily insulin glargine , both in combination with insulin aspart, in participants with T1D.

Conditions and MedDRA coding

Type 1 Diabetes

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Diagnosed with type 1 diabetes mellitus ≥ 1 year before screening.
2. Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.
3. HbA1c from 7.0–10.0% (53.0–85.8 mmol/mol), both inclusive, at screening confirmed by central laboratory analysis.
4. Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement.

Exclusion criteria 7

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 childbearing potential and not using adequate contraceptive method.
4. Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
5. Any condition, except for conditions associated with type 1 diabetes mellitus, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol. Anticipated initiation or anticipated change in concomitant medications (for more than 15 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with thyroid hormones, or systemic corticosteroids).
6. Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke’s questionnaire question.
7. Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in HbA1c From baseline week 0 (V6) to week 26 (V32). Unit: %-point

Secondary endpoints 11

1. Change in time in range 3.9– 10.0 mmol/L (70–180 mg/dL). Using CGM system, Dexcom G7
2. Time spent <3.0 mmol/L (54 mg/dL). Using CGM system, Dexcom G7
3. Change in time spent >10.0 mmol/L (180 mg/dL). Using CGM system, Dexcom G7
4. Number of severe hypoglycaemic episodes (level 3)
5. Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL], confirmed by BG meter)
6. 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)
7. Number of CGM-based clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL]). Using CGM system, Dexcom G7
8. Mean total weekly insulin dose
9. Change in body weight
10. Change in ITSQ total score
11. Change in ADAQ total score

Investigational products

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

Test 6

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 9

Locations

4 EU/EEA countries · 49 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 58 files

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

Application history

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