Baseline and week 24 mean A1C, FPG, proinsulin-to-insulin ratio, and HOMA-β and least-squares mean change from baseline to study end point with sitagliptin or placebo treatment
| . | n . | Week 0 (baseline) mean ± SD . | Week 24 mean ± SD . | Least-squares mean change from baseline (95% CI) . |
|---|---|---|---|---|
| A1C (%) | ||||
| Placebo | 244 | 8.03 ± 0.82 | 8.20 ± 1.37 | 0.18 (0.06 to 0.30) |
| Sitagliptin 100 mg q.d. | 229 | 8.01 ± 0.88 | 7.39 ± 1.15 | −0.61 (−0.74 to −0.49)* |
| Sitagliptin 200 mg q.d. | 238 | 8.08 ± 0.94 | 7.31 ± 1.14 | −0.76 (−0.88 to −0.64)* |
| FPG (mmol/l) | ||||
| Placebo | 247 | 9.8 ± 2.3 | 10.0 ± 3.1 | 0.3 (−0.0 to 0.5) |
| Sitagliptin 100 mg q.d. | 234 | 9.5 ± 2.4 | 8.8 ± 2.5 | −0.7 (−1.0 to −0.4)* |
| Sitagliptin 200 mg q.d. | 244 | 9.7 ± 2.5 | 8.7 ± 2.6 | −0.9 (−1.2 to −0.7)* |
| Proinsulin-to-insulin ratio | ||||
| Placebo | 220 | 0.44 ± 0.30 | 0.44 ± 0.28 | −0.01 (−0.04 to 0.02) |
| Sitagliptin 100 mg q.d. | 210 | 0.47 ± 0.82 | 0.37 ± 0.25 | −0.08 (−0.11 to −0.05)† |
| Sitagliptin 200 mg q.d. | 217 | 0.44 ± 0.48 | 0.34 ± 0.22 | −0.11 (−0.14 to −0.07)* |
| HOMA-β | ||||
| Placebo | 235 | 55.8 ± 52.1 | 56.3 ± 61.5 | 0.3 (−6.0 to 6.5) |
| Sitagliptin 100 mg q.d. | 218 | 57.6 ± 71.7 | 70.9 ± 91.8 | 13.2 (6.7 to 19.7)† |
| Sitagliptin 200 mg q.d. | 228 | 55.2 ± 53.4 | 68.4 ± 66.3 | 13.1 (6.8 to 19.5)† |
| . | n . | Week 0 (baseline) mean ± SD . | Week 24 mean ± SD . | Least-squares mean change from baseline (95% CI) . |
|---|---|---|---|---|
| A1C (%) | ||||
| Placebo | 244 | 8.03 ± 0.82 | 8.20 ± 1.37 | 0.18 (0.06 to 0.30) |
| Sitagliptin 100 mg q.d. | 229 | 8.01 ± 0.88 | 7.39 ± 1.15 | −0.61 (−0.74 to −0.49)* |
| Sitagliptin 200 mg q.d. | 238 | 8.08 ± 0.94 | 7.31 ± 1.14 | −0.76 (−0.88 to −0.64)* |
| FPG (mmol/l) | ||||
| Placebo | 247 | 9.8 ± 2.3 | 10.0 ± 3.1 | 0.3 (−0.0 to 0.5) |
| Sitagliptin 100 mg q.d. | 234 | 9.5 ± 2.4 | 8.8 ± 2.5 | −0.7 (−1.0 to −0.4)* |
| Sitagliptin 200 mg q.d. | 244 | 9.7 ± 2.5 | 8.7 ± 2.6 | −0.9 (−1.2 to −0.7)* |
| Proinsulin-to-insulin ratio | ||||
| Placebo | 220 | 0.44 ± 0.30 | 0.44 ± 0.28 | −0.01 (−0.04 to 0.02) |
| Sitagliptin 100 mg q.d. | 210 | 0.47 ± 0.82 | 0.37 ± 0.25 | −0.08 (−0.11 to −0.05)† |
| Sitagliptin 200 mg q.d. | 217 | 0.44 ± 0.48 | 0.34 ± 0.22 | −0.11 (−0.14 to −0.07)* |
| HOMA-β | ||||
| Placebo | 235 | 55.8 ± 52.1 | 56.3 ± 61.5 | 0.3 (−6.0 to 6.5) |
| Sitagliptin 100 mg q.d. | 218 | 57.6 ± 71.7 | 70.9 ± 91.8 | 13.2 (6.7 to 19.7)† |
| Sitagliptin 200 mg q.d. | 228 | 55.2 ± 53.4 | 68.4 ± 66.3 | 13.1 (6.8 to 19.5)† |
P ≤ 0.001 for least-squares mean difference for sitagliptin 100 or 200 mg vs. placebo;
P ≤ 0.01 for least-squares mean difference for sitagliptin 100 or 200 mg vs. placebo. P = NS for sitagliptin at 200- vs. 100-mg comparisons. (To convert glucose values from mmol/l to mg/dl, divide by 0.05551.)