Onwards 6: Trial comparison of once day insulin vs. a new weekly insulin
This study compares insulin icodec (a new insulin) to insulin degludec (an insulin already available on the market known as “Trulicity”) in people with type 1 diabetes.
The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily.
Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week, or insulin degludec that participants will have to inject once a day at the same time every day. Which treatment participants get is decided at random. Participants will also get mealtime insulin.
The study will last for about 1 year and 2 months. Participants will have 28 clinic visits and 28 phone calls with the study doctor. At 11 clinic visits, participants will have blood samples taken; at 6 of the clinic visits, participants cannot eat or drink (except for water) for 8 hours before the visit.
Participants will be asked to wear a Dexcom sensor that measures their blood sugar continuously for the duration of the study.
Women cannot take part if they are pregnant, breastfeeding, or plan to become pregnant during the study period.
Inclusion Criteria:
Exclusion Criteria:
The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily.
Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week, or insulin degludec that participants will have to inject once a day at the same time every day. Which treatment participants get is decided at random. Participants will also get mealtime insulin.
The study will last for about 1 year and 2 months. Participants will have 28 clinic visits and 28 phone calls with the study doctor. At 11 clinic visits, participants will have blood samples taken; at 6 of the clinic visits, participants cannot eat or drink (except for water) for 8 hours before the visit.
Participants will be asked to wear a Dexcom sensor that measures their blood sugar continuously for the duration of the study.
Women cannot take part if they are pregnant, breastfeeding, or plan to become pregnant during the study period.
Inclusion Criteria:
- Male or female aged greater than or equal to 18 years at the time of signing informed consent.
- Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening.
- Treated with multiple daily insulin injections (basal and bolus insulin analogue regimes) greater than or equal to 1 year prior to the day of screening.
- HbA1c below10% at screening visit based on analysis from the central laboratory.
Exclusion Criteria:
- Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
- Chronic heart failure classified as New York Heart Association (NYHA) Class IV at screening.
- Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening
- Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) within 5 years prior to the day of screening.
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria (i.e. Metformin, Glimepiride, Pioglitozone, etc.) within the past 90 days prior to the day of screening