Table 1.
The inclusion criteria and study design of the trials
| Study 1 | Study 2 | Study 3 | ||
|---|---|---|---|---|
| N | 181 | 59 | 64 | |
| ClinicalTrials.gov No. | NCT0023660 | NCT01071850 | NCT01117584 | |
| Disease status | Treatment naïve | Treatment naïve (n = 28) and prior treatment (n = 31) | Inadequately controlled on a daily dose of 1.5 g metformin (>6 weeks) | |
| BMI ( kg m −2 ) | 27–50 | 20–45 | ||
| HbA1c (%) a | <10.5 | 6.8–9.5 | 7.0–9.5 | |
| Diet and exercise regimen | 600 kcal deficient diet and physical activity at all visits | Reported at stable diet and exercise regimen throughout the study | ||
| Study design | ||||
| Trial duration | 66 weeks | 14 weeks | ||
| Washout phase | – | – | 6 weeks | – |
| Placebo run‐in | 6 weeks | 2 weeks | ||
| Placebo treatment phase | 60 weeks | 12 weeks | ||
| Follow‐up phase | – | 4 weeks | ||
BMI, body mass index; HbA1c, glycosylated haemoglobin
a
As measured at the first clinic visit