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/S
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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: * K…
Interventions
- DrugInsulin icodec
Insulin icodec will be administered as subcutaneous injection
- DrugInsulin glargine
Insulin glargine will be administered as subcutaneous injection.
- DrugInsulin aspart
Insulin aspart will be administered as a subcutaneous injection.
Locations (193)
- Cullman Clinical TrialsCullman, Alabama
- John Muir HealthConcord, California
- Headlands Research California, LLCEscondido, California
- Clinical Res of Central CaFresno, California
- Providence Medical FoundationFullerton, California
- Scripps Whittier Diabetes InstLa Jolla, California