A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6)
A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6)
This study compares insulin icodec (a new insulin) to insulin degludec (an insulin already
 available on the market) 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 a mealtime insulin.

 The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach.

 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 clinic visits participants cannot eat or drink (except for water) for 8 hours before the
 visit.

 Participants will be asked to wear a sensor that measures your blood sugar all the time.
 Participants will be asked to wear it for a total of 57 weeks (around 1 year).

 Women cannot take part if pregnant, breast-feeding 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 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 randomisation. Pharmacological pupil-dilation is a
 requirement unless using a digital fundus photography camera specified for non-dilated
 examination.