Type 2 diabetes (T2D) and increased cardiovascular (CV) risk not in adequate glycaemic control on 1–3 marketed oral glucose lowering medications.
Conditions
Brief summary
"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)"
Detailed description
- 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
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| "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)" | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 | — |