Efficacy and safety of zenagamtide s.c. once weekly compared to insulin glargine s.c. once daily in participants with type 2 diabetes and increased cardiovascular risk inadequately controlled on 1–3 oral glucose-lowering medications (AMBITION 7)

Condition studied

Type 2 diabetes (T2D) and increased cardiovascular (CV) risk not in adequate glycaemic control on 1–3 marketed oral glucose lowering medications.

Investigational medicinal product(s)

Eligibility

Primary endpoint

"Change in haemoglobin A1c (HbA1c) from baseline (week 0) to week 52 'Time to first occurrence of a 4-point MACE endpoint consisting of: -CV death -non-fatal myocardial infarction -non-fatal stroke -hospitalisation for unstable angina from baseline (week 0) to CCI (up to 104 weeks or more)"

Endpoint detail

- Relative change in body weight - Change in HbA1c from baseline (week 0) to week 52, Time to first occurrence of a 3-point MACE endpoint consisting of: -CV death -non-fatal myocardial infarction -non-fatal stroke from baseline (week 0) to CCI (up to 104 weeks or more), - Change in waist circumference - Change in systolic blood pressure - Change in high-sensitivity C-reactive protein (hsCRP) - Change in Triglycerides and Non-high-density lipoprotein (non-HDL) cholesterol from baseline (week 0) to week 52, CCI, CCI