Table 1.
Vildagliptin monotherapy studies
| Study | Study description | Randomized patients* | Treatment duration** | Reference |
|---|---|---|---|---|
| 1 | Placebo-controlled dose-ranging study (efficacy/safety) in drug-naïve T2DM patients (HbA1c 7.5%–10.0%) | 354 | 24 weeks | 34 |
| 2 | Placebo-controlled dose-ranging study (efficacy/safety) in drug-naïve T2DM patients (HbA1c 7.5%–10.0%) | 632 | 24 weeks | 25 |
| 3 | Placebo-controlled long-term efficacy/safety study in drug-naïve T2DM patients with mild hyperglycemia (HbA1c 6.2%–7.5%) | 306 | 52 weeks | 31 |
| 4 | Placebo-controlled 52-week extension to study 3 | 131 | 104 weeks | 30 |
| 5 | Placebo-controlled mechanistic study in drug-naïve T2DM patients with mild hyperglycemia (HbA1c ≤ 7.5%) | 89 | 52 weeks | 36 |
| 6 | Placebo-controlled efficacy/mechanistic study in diet-controlled T2DM patients (HbA1c 6.3%–10.0%) | 40 | 4 weeks | 38 |
| 7 | Placebo-controlled mechanistic study in drug-naïve T2DM patients (HbA1c 6.5%–10.0%) | 31 | 4 weeks | 39 |
| 8 | Placebo-controlled mechanistic study in drug-naïve T2DM patients (HbA1c ≤ 7.5%) | 30 | 4 weeks | 40 |
| 9 | Active-controlled (metformin) long-term efficacy/safety study in drug-naïve T2DM patients (HbA1c 7.5%–11.0%) | 780 | 52 weeks | 32 |
| 10 | Active-controlled (metformin) 52-week extension to study 9 | 463 | 104 weeks | 27 |
| 11 | Active-controlled (metformin) efficacy/safety study in drug-naïve elderly (≥65 years) T2DM patients (HbA1c 7.0%–9.0%) | 335 | 24 weeks | 33 |
| 12 | Active-controlled (gliclazide) long-term efficacy/safety study in drug-naïve T2DM patients (HbA1c 7.5%–11%) | 1092 | 104 weeks | 26 |
| 13 | Active-controlled (acarbose) efficacy/safety study in drug-naïve T2DM patients (HbA1c 7.5%–11%) | 661 | 24 weeks | 28 |
| 14 | Active-controlled (rosiglitazone) efficacy/safety study in drug-naïve T2DM patients (HbA1c 7.5%–11%) | 786 | 24 weeks | 29 |
| 15 | Active-controlled (voglibose) efficacy/safety study in Japanese T2DM patients (HbA1c 6.5%–10%) | 380 | 12 weeks | 37 |
| 16 | Placebo-controlled study in subjects with IGT | 179 | 12 weeks | 49 |
| 17 | Uncontrolled study in subjects with IFG | 22 | 6 weeks | 50 |
| 18 | Pooled monotherapy analysis in patients < and ≥65 years | NA | ≥24 weeks | 10 |
| 19 | Pooled monotherapy analysis in patients < and ≥75 years | NA | ≥24 weeks | 45 |
Notes:
*
For extension studies, patients who entered extension;
**
For extension studies, duration of core + extension study.
Abbreviations: HbA1c, glycosylated hemoglobin; IGT, impaired glucose tolerance; IFG, impaired fasting glucose; NA, not applicable; T2DM, type 2 diabetes.