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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Insulin icodec + insulin aspart 		Participants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart .
  • Drug: Insulin icodec
    Insulin icodec will be administered as subcutaneous injection
  • Drug: Insulin aspart
    Insulin aspart will be administered as a subcutaneous injection.
Active Comparator
Insulin glargine+ insulin aspart 		Participants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart.
  • Drug: Insulin glargine
    Insulin glargine will be administered as subcutaneous injection.
  • Drug: Insulin aspart
    Insulin aspart will be administered as a subcutaneous injection.

Recruiting Locations

MedStar Health Research Institute
Hyattsville 4358821, Maryland 4361885 20782

More Details

Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

Novo Nordisk
(+1) 866-867-7178
clinicaltrials@novonordisk.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.