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Comparing once-weekly insulin icodec to once-daily insulin glargine, both with insulin aspart, in adults with type 1 diabetes

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

Phase 3 Interventional Novo Nordisk A/S · NCT07076199

This trial tests whether taking insulin icodec once a week controls blood sugar as well as taking insulin glargine every day in adults with type 1 diabetes who also use insulin aspart for meals.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment877 (estimated)
Ages18 Years and up
SexAll
SponsorNovo Nordisk A/S Industry-sponsored
Locations193 sites (Cullman, Alabama and 192 other locations)
Trial IDNCT07076199 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional study compares weekly basal insulin icodec with daily basal insulin glargine, with all participants using insulin aspart for bolus/mealtime coverage. Eligible adults have type 1 diabetes for at least one year, have been on multiple daily injections for at least six months, and have an HbA1c between 7.0% and 10.0% confirmed by a central lab. The treatment period lasts about 8.5 months with regular self‑measured glucose profiles and clinic visits to monitor glycemic control and safety. The study is sponsored by Novo Nordisk and conducted at multiple U.S. clinical sites.

Who should consider this trial

Good fit: Adults with type 1 diabetes for at least one year who are using multiple daily insulin injections, have an HbA1c of 7.0%–10.0%, and are willing to perform required self-monitored glucose checks and attend study visits are ideal candidates.

Not a fit: People who are pregnant or breastfeeding, have known hypersensitivity to the study insulins, recently used other investigational drugs, or whose HbA1c or insulin regimen falls outside eligibility criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, a once-weekly basal insulin could simplify insulin routines, improve adherence, and maintain similar blood sugar control compared with daily basal injections.

How similar studies have performed: Weekly basal insulin icodec has shown promising results in Type 2 diabetes and early-phase work, but large randomized phase 3 evidence in Type 1 diabetes is limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year before screening.
* Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.
* HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol/mol)), both inclusive, at screening confirmed by central laboratory analysis.
* 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:

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Previous participation in this study. Participation is defined as signed informed consent.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
* 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.
* 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).
* Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question.
* Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.

Where this trial is running

Cullman, Alabama and 192 other locations

+143 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetes Mellitus, Type 1
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.