Table 2. Results for fasting and post‐meal end‐points at week 52.
| n | Week 0 mean (SD) | Week 52 mean (SD) | Change from week 0 (baseline) to week 52 (mean [95% CI]) | |
|---|---|---|---|---|
| HbA1c (%) | ||||
| P/S | 59 | 7.8 (0.6) | 7.2 (0.5) | −0.6 (−0.7 to −0.4)*** |
| S/S | 50 | 8.0 (0.7) | 7.3 (0.7) | −0.6 (−0.8 to −0.5)*** |
| Fasting plasma glucose (mmol/L) | ||||
| P/S | 59 | 8.0 (1.6) | 7.3 (1.3) | −0.7 (−1.0 to −0.4)*** |
| S/S | 50 | 7.8 (1.4) | 7.2 (1.1) | −0.7 (−1.0 to −0.4)*** |
| 1,5‐anhydroglucitol (ug/mL) | ||||
| P/S | 59 | 7.2 (5.3) | 12.0 (7.4) | 4.8 (3.8 to 5.9)*** |
| S/S | 50 | 6.5 (4.2) | 11.4 (6.4) | 5.0 (3.8 to 6.2) *** |
| Fasting insulin (pmol/L) | ||||
| P/S | 59 | 47.9 (26.0) | 52.3 (27.8) | 4.4 (−1.0 to 9.7) |
| S/S | 50 | 43.8 (20.3) | 47.9 (21.0) | 4.1 (−0.7 to 8.8) |
| HOMA‐IR | ||||
| P/S | 59 | 2.5 (1.5) | 2.5 (1.6) | 0.0 (−0.3 to 0.4) |
| S/S | 50 | 2.3 (1.2) | 2.2 (1.1) | 0.0 (−0.3 to 0.2) |
| HOMA‐β | ||||
| P/S | 59 | 33.0 (17.9) | 42.5 (26.2) | 9.4 (4.6 to 14.3)*** |
| S/S | 50 | 30.8 (17.1) | 39.9 (19.4) | 9.0 (4.5 to 13.5)*** |
| 2‐h Post‐meal glucose (mmol/L) | ||||
| P/S | 59 | 12.4 (3.2) | 9.8 (2.3) | −2.6 (−3.4 to −1.8)*** |
| S/S | 50 | 12.3 (3.0) | 9.6 (2.3) | −2.7 (−3.4 to −2.0)*** |
| 2‐h Post‐meal insulin (pmol/L) | ||||
| P/S | 59 | 312.2 (183.6) | 316.3 (190.1) | 4.1 (−33.3 to 41.5) |
| S/S | 50 | 278.9 (132.8) | 307.1 (183.1) | 28.2 (−11.4 to 67.9) |
| Glucose AUC (mmol h/L) | ||||
| P/S | 59 | 23.9 (4.7) | 20.1 (3.6) | −3.8 (−4.9 to −2.7)*** |
| S/S | 50 | 23.9 (4.2) | 20.3 (3.7) | −3.5 (−4.5 to −2.6)*** |
| Insulin AUC (pmol h/L) | ||||
| P/S | 59 | 465.5 (242.7) | 498.0 (245.4) | 32.5 (−4.2 to 69.2) |
| S/S | 50 | 445.5 (213.5) | 490.9 (260.0) | 45.4 (1.9 to 88.8)* |
| C‐peptide AUC (nmol h/L) | ||||
| P/S | 59 | 3.1 (1.0) | 3.6 (1.0) | 0.5 (0.3 to 0.7)*** |
| S/S | 50 | 3.1 (0.9) | 3.5 (0.9) | 0.4 (0.2 to 0.6)*** |
| Insulinogenic index | ||||
| P/S | 59 | 0.3 (0.2) | 0.6 (0.3) | 0.2 (0.1 to 0.2)*** |
| S/S | 50 | 0.3 (0.2) | 0.4 (0.3) | 0.1 (0.1 to 0.2)*** |
***P < 0.001, **P < 0.01, *P < 0.05. Missing data were not imputed. AUC, total area under the concentration‐versus‐time curve; CI, confidence interval; HOMA‐β: homeostasis model assessment of β‐cell function; HOMA‐IR: homeostasis model assessment of insulin resistance; P/S, patients received placebo in double‐blind period and sitagliptin in open‐label period; SD, standard deviation; S/S, patients received sitagliptin in double‐blind and open‐label periods.