A research study to see how weekly IcoSema controls blood sugar levels when compared with daily insulin degludec/insulin aspart (IDegAsp) in people with poorly controlled type 2 diabetes (COMBINE 5)

Prior treatment

• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
• Any episodes of diabetic ketoacidosis within 90 days before screening.
• Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
• Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before 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.

Other illness

• Chronic heart failure classified as being in New York Heart Association Class IV at screening.

Lab values

• Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids).

Other

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
• Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.

• Male or female
• Age 18 years or above at the time of signing the informed consent.
• Diagnosed with T2D ≥ 180 days before screening.
• HbA1c of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
• Treated with once-daily or twice-daily pre-mixed insulin (containing 25%, 30% or 50% fast/rapid acting component) 20-80 units/day ≥ 90 days before screening. The treatment can be with or without any of the following anti-diabetic drugs with stable daily doses ≥ 90 days before screening: Metformin Sulfonylureas Meglitinides (glinides) DPP-4 inhibitors Sodium-glucose co-transporter 2 inhibitors Alpha-glucosidase-inhibitors Thiazolidinediones Marketed oral combination products only including the products listed above.
• Body mass index (BMI) ≤ 40.0 kg/m2.