Table 1.
Secondary and other efficacy endpoints
| Point estimate for treatment difference (95% CI) | |||||
|---|---|---|---|---|---|
| Alogliptin once daily (n = 71) | Alogliptin once daily/metformin once daily (n = 152) | Alogliptin once daily/metformin twice daily (n = 151) | Alogliptin once daily/metformin once daily vs alogliptin once daily alone | Alogliptin once daily/metformin once daily vs alogliptin once daily/metformin twice daily | |
| Number patients evaluable | 71 | 149 1 or 152 | 151 | ||
| Number of patients with HbA1c <7.0% at week 24, n (%) | 3 (4.8) | 48 (35.0) | 48 (34.3) | 30.3 (20.7, 39.8) | 0.8 (−10.5, 12.0) |
| Mean changes from baseline to week 24, mean (s.d.) | |||||
| Fasting glucose, mg/dL | 7.4 (26.9) | −7.6 (26.4) | −18.2 (25.4) | −14.9 (−22.5, −7.4) | 10.6 (4.7, 16.5) |
| Fasting insulin, μU/mL | −0.1 (4.0) | −0.2 (4.0) | −0.6 (4.2) | −0.1 (−1.2, 1.1) | 0.3 (−0.6, 1.3) |
| Fasting glucagon, pg/mL | −0.6 (15.1) | 1.9 (18.4) | −0.8 (18.6) | 2.5 (−2.4, 7.5) | 2.7 (−1.5, 6.9) |
| HOMA‐IR | 0.2 (2.1) | −0.3 (2.0) | −0.6 (2.0) | −0.5 (−1.1, 0.1) | 0.3 (−0.1, 0.8) |
| HOMA‐β | −3.4 (13.2) | 3.2 (17.4) | 4.8 (15.4) | 6.6 (2.0, 11.2) | −1.6 (−5.3, 2.2) |
| Body weight, kg | −0.1 (1.5) | 0.0 (1.5) | 0.0 (1.7) | 0.1 (−0.3, 0.5) | 0.0 (−0.4, 0.4) |
Abbreviations: HOMA‐β, homeostatic model assessment of β‐cell function; HOMA‐IR, homeostatic model assessment of insulin resistance; s.d., standard deviation.
1
Three randomized patients were not evaluable for evaluation of fasting insulin, HOMA‐IR or HOMA‐β.