Placebo | Vildagliptin | |
---|---|---|
Primary endpoint | ||
Units insulin | 47 (16 – 62) | 34 (12 – 62) |
Secondary endpoints | ||
Glycemic variability end of study (SD) | 2.1 (1.1 – 2.8) | 1.5 (1.0 – 3.6) |
Change in weight (kg) | 3 (−2.5 – 5.5) | 0.5 (−2.6 – 4) |
Hypoglycemia during the study (nr per pat) | 1.5 (0 – 5) | 1.0 (0 – 8) |
Change in blood-pressure (mmHg) | ||
Systolic | −3 (−12 – 6) | 2.5 (−14 – 10) |
Diastolic | −1.5 (−9 – 3) | −0.5 (−6 – 11) |
Change in LDL (mmol/L) | 0 (−1 – 0.6) | −0.3 (−1.4 – 0) |
Change in SAF (skin AGEs) (AU) | 0.1 (−0.4 – 0.8) | 0.15 (−0.4 – 0.6) |
Safety | ||
Patients with one or more hypoglycemia (%) | 67% | 78% |
Patients with severe hypoglycemia (%) | 0% | 0% |
Patients with one or more AE (%) | 100% | 44% |
Patients with one or more SAE (%) | 0% | 0% |
Other | ||
Delta HbA1c (mmol/mol) | −6.5 (−18 - 7) | −6 (−25 - 4) |
(%) | −0.6 (−1.6 – 0.6) | −0.5 (−2.3 - 0.3) |
Compliance (% of tablets taken) | 96% | 98% |