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Clinical Trials/NCT07076199
NCT07076199
Recruiting
Phase 3

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

Novo Nordisk A/S363 sites in 1 country877 target enrollmentStarted: August 11, 2025Last updated:
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InterventionsInsulin icodecInsulin aspartInsulin glargine
DrugsInsulin icodecInsulin glargineInsulin aspart

Overview

Phase
Phase 3
Status
Recruiting
Enrollment
877
Locations
363
Primary Endpoint
Change in glycosylated haemoglobin (HbA1c)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Insulin icodec + insulin aspart

Experimental

Participants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart .

Intervention: Insulin icodec (Drug)

Insulin icodec + insulin aspart

Experimental

Participants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart .

Intervention: Insulin aspart (Drug)

Insulin glargine+ insulin aspart

Active Comparator

Participants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart.

Intervention: Insulin glargine (Drug)

Insulin glargine+ insulin aspart

Active Comparator

Participants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart.

Intervention: Insulin aspart (Drug)

Outcomes

Primary Outcomes

Change in glycosylated haemoglobin (HbA1c)

Time Frame: From baseline (week 0) to week 26

Measured in percentage (%)-points.

Secondary Outcomes

  • Number of severe hypoglycaemic episodes (level 3)(From baseline (week 0) to week 31)
  • Change in time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))(From baseline (week-2-0) to week 22-26)
  • Time spent less than (<)3.0 mmol/L (54 mg/dL)(From week 22 to week 26)
  • Change in time spent greater than (>)10.0 mmol/L (180 mg/dL)(From baseline (week-2-0) to week 22-26)
  • Number of clinically significant hypoglycaemicepisodes (level 2) (<3.0mmol/L [54 mg/dL],confirmed by blood glucose (BG) meter)(From baseline (week 0) to week 31)
  • Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL], severe hypoglycaemic confirmed by BG meter) or episodes (level 3)(From baseline (week 0) to week 31)
  • Number of continuous glucose continuous glucose (CGM)-based clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL])(From baseline (week 0) to week 31)
  • Mean total weekly insulin dose(From week 24 to week 26)
  • Change in body weight(From baseline (week 0) to week 26)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (363)

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