type 2 diabetes
Conditions
Interventions
Participants will be randomised (1:1) to receive once weekly IcoSema or once weekly insulin icodec.
-an up to 2 weeks screening period
-a 52-week treatment period
-a 5-week follow-up period
IcoSema
Sponsors
Takase Juri
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female and age above or equal to 18 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus >= 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 basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) 20-80 units/day >= 90 days before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes. The treatment can be with or without any of the following anti-diabetic drugs with stable doses >=90 days before screening: - Metformin - Sulfonylureasa - 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.
Exclusion criteria
Exclusion criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. -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). -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. - Chronic heart failure classified as being in New York Heart Association Class IV at screening. - Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator. - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c: From baseline week 0 (V2) to week 52 (V54) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change in body weight: From baseline week 0 (V2) to week 52 (V54) -Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3): From baseline week 0 (V2) to week 57 (V56) | — |
Countries
Australia, Belgium, Bulgaria, China, Croatia, Finland, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Romania, Russia, Serbia, South Africa, South Korea, Taiwan, Turkey, United States
Contacts
Public ContactRegistrar Clinical trail information
Novo Nordisk Pharma Ltd.
Outcome results
None listed