Table 3.
Measures of glycemic control in the linagliptin and placebo groups at 12 weeks in Japanese patients, and 24 weeks in Asian (non‐Japanese) and white patients (full analysis set; last observation carried forward)
| Study 1 | Study 2 | |||||
|---|---|---|---|---|---|---|
| Japanese* 12 weeks | Asian 24 weeks | White 24 weeks | ||||
| Linagliptin | Placebo | Linagliptin | Placebo | Linagliptin | Placebo | |
| HbA1c (%) | ||||||
| Patients (n) | 159 | 80 | 155 | 72 | 178 | 90 |
| Change from baseline† (adjusted mean ± SE) | −0.24 ± 0.06 | 0.63 ± 0.08 | −0.45 ± 0.07 | 0.46 ± 0.10 | −0.42 ± 0.06 | 0.10 ± 0.09 |
| Difference vs placebo† (adjusted mean ± SE) | −0.87 ± 0.09 | −0.91 ± 0.12 | −0.52 ± 0.11 | |||
| P‐value | <0.0001 | <0.0001 | <0.0001 | |||
| FPG (mg/dL) | ||||||
| Patients (n) | 159 | 80 | 155 | 70 | 163 | 78 |
| Change from baseline‡ (adjusted mean ± SE) | −12.3 ± 1.9 | 7.4 ± 2.5 | −10.9 ± 12.1 | 12.8 ± 12.5 | 7.5 ± 12.1 | 30.8 ± 12.0 |
| Difference vs placebo‡ (adjusted mean ± SE) | −19.7 ± 2.9 | −23.7 ± 5.1 | −23.3 ± 4.9 | |||
| P‐value | <0.0001 | <0.0001 | <0.0001 | |||
*Previously reported by Kawamori et al.12 †In study 1, the model includes treatment, baseline glycated hemoglobin (HbA1c) and number of prior oral antidiabetes drugs (OADs); in study 2, the model includes baseline HbA1c, number of prior OADs, race, treatment group and treatment × race interaction. ‡In study 1, the model includes treatment, baseline fasting plasma glucose (FPG) and number of prior OADs; in study 2, the model includes baseline HbA1c, baseline FPG, number of prior OADs, race, treatment group and treatment × race interaction. SE, standard error.