A 40-week study comparing the efficacy, safety and patient-reported outcomes of once weekly IcoSema and once or twice daily insulin degludec/insulin aspart 100 units/mL, both treatment arms with or without oral anti-diabetic drugs, in participants with type 2 diabetes inadequately controlled with daily pre-mixed insulin. COMBINE 5

Condition studied

Type 2 diabetes

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change in HbA1c

Endpoint detail

Change in body weight, 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), Weekly insulin dose (total), Change in DTSQs total treatment satisfaction, Change in HbA1c, Change in mean 7-point SMPG profiles, Change in mean post-prandial glucose increment (over all meals), Time spent < 3.0 mmol/L (54 mg/dL), Time spent > 10.0 mmol/L (180 mg/dL), Change in time in range 3.9-10.0 mmol/L (70-180 mg/dL), Change in FPG, Change in Treatment Related Impact Measure - Diabetes (TRIM-D) score, Change in EQ-5D-5L score, Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L [54 mg/dL], confirmed by BG meter), Number of severe hypoglycaemic episodes (level 3)