A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Registration Number
- NCT07076199
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 877
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin icodec + insulin aspart Insulin icodec Participants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart . Insulin icodec + insulin aspart Insulin aspart Participants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart . Insulin glargine+ insulin aspart Insulin glargine Participants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart. Insulin glargine+ insulin aspart Insulin aspart Participants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart.
- Primary Outcome Measures
Name Time Method Change in glycosylated haemoglobin (HbA1c) From baseline (week 0) to week 26 Measured in percentage (%)-points.
- Secondary Outcome Measures
Name Time Method 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 Measured in %-points.
Time spent less than (<)3.0 mmol/L (54 mg/dL) From week 22 to week 26 Measured in % of time.
Change in time spent greater than (>)10.0 mmol/L (180 mg/dL) From baseline (week-2-0) to week 22-26 Measured in %-points.
Number of severe hypoglycaemic episodes (level 3) From baseline (week 0) to week 31 Measured as number of episodes.
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 Measured as number of episodes.
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 Measured as number of episodes.
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 Measured as number of episodes.
Mean total weekly insulin dose From week 24 to week 26 Measured in insulin units.
Change in body weight From baseline (week 0) to week 26 Measured in Kilogram (kg).
Trial Locations
- Locations (167)
Cullman Clinical Trials
🇺🇸Cullman, Alabama, United States
John Muir Health
🇺🇸Concord, California, United States
Headlands Research California, LLC
🇺🇸Escondido, California, United States
Clinical Res of Central Ca
🇺🇸Fresno, California, United States
Providence Research
🇺🇸Fullerton, California, United States
Scripps Whittier Diabetes Inst
🇺🇸La Jolla, California, United States
Loma Linda University Faculty Medical Clinics
🇺🇸Loma Linda, California, United States
Pacific Clinical Studies
🇺🇸Los Alamitos, California, United States
Pasadena Clinical Trials
🇺🇸Pasadena, California, United States
WestenU Health
🇺🇸Pomona, California, United States
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