RECRUITINGPhase 3INTERVENTIONAL
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
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Previous participation in this study. Participation is defined as signed willing to sign a consent form.
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Insulin icodec
Insulin icodec will be administered as subcutaneous injection
DRUG
Insulin glargine
Insulin glargine will be administered as subcutaneous injection.
DRUG
Insulin aspart
Insulin aspart will be administered as a subcutaneous injection.
Locations (20)
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 Medical Foundation
Fullerton, California, United States
Scripps Whittier Diabetes Inst
La Jolla, California, United States
Loma Linda University Faculty Medical Clinics
Loma Linda, 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
WestenU Health
Pomona, California, United States
Alliance Clinical Network
San Diego, California, United States
Mills Health Center
San Mateo, California, United States
Center for Endocrine DM and Metabolic Disorders
Santa Clarita, California, United States
University Clin Investigators
Tustin, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Denver Endocrinology Diabetes and Thyroid Center
Englewood, Colorado, United States
Optumcare Clinical Trials,LLC-Golden
Golden, Colorado, United States
Northeast Research Institute
Fleming Island, Florida, United States