Do you have Type 1 Diabetes and also struggle with weight management?
This study will compare 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.
Would you like to take part? Would you like a friend or family member to take part?
As a volunteer in a research study, you will receive personal study-related medical care from the study doctor and regular follow up on your type 1 diabetes to monitor the effectiveness of the care you will receive. The results of this research will be used to find out if the experimental medication being studied will be of benefit to others with type 1 diabetes or not. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Have been diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year before screening.
- Have been treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.
- Have HbA1c levels from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol/mol)), both inclusive, at screening confirmed by central laboratory analysis.
- Have an ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator’s judgement
You may not qualify to participate in this study if you:
- Have any known or suspected hypersensitivity to study intervention(s) or related products.
- Have previously participated in this study. Participation is defined as signed informed consent.
- Are a female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- Have been exposed to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
- Have 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.
- Have any 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).
- Have known hypoglycaemic unawareness as indicated by the Investigator according to Clarke’s questionnaire question.
- Have had any recurrent severe hypoglycaemic episodes within the last year as judged by the investigator
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.
Participants who qualify for this study will receive a study-related health examination at no cost, as well as possible compensation for time and travel.
