Table 2. Results for fasting and postmeal glycemic 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 | 54 | 7.8 (0.8) | 7.0 (0.7) | −0.8 (−1.0, −0.6)*** |
| S/S | 60 | 7.8 (0.7) | 7.0 (0.7) | −0.8 (−1.0,−0.7)*** |
| Fasting plasma glucose (mg/dL) | ||||
| P/S | 54 | 150.5 (31.2) | 135.6 (25.1) | −14.9 (−20.6, −9.3)*** |
| S/S | 60 | 149.9 (34.3) | 128.0 (20.9) | −21.9 (−28.0, −15.7)*** |
| 1,5‐anhydroglucitol (μg/mL) | ||||
| P/S | 54 | 11.6 (8.0) | 16.8 (9.1) | 5.1 (3.7, 6.5)*** |
| S/S | 60 | 11.0 (6.9) | 17.1 (9.2) | 6.1 (4.6, 7.5)*** |
| Fasting insulin (μU/mL) | ||||
| P/S | 54 | 5.4 (3.1) | 6.5 (3.9) | 1.0 (0.4, 1.7)** |
| S/S | 60 | 5.2 (3.5) | 6.2 (4.0) | 1.0 (0.4, 1.6)** |
| HOMA‐IR | ||||
| P/S | 54 | 2.0 (1.2) | 2.2 (1.5) | 0.2 (−0.1, 0.4) |
| S/S | 60 | 1.9 (1.3) | 2.0 (1.3) | 0.1 (−0.2, 0.3) |
| HOMA‐β | ||||
| P/S | 54 | 25.0 (17.6) | 34.1 (19.0) | 9.2 (5.2, 13.1)*** |
| S/S | 60 | 23.7 (17.4) | 37.0 (26.8) | 13.3 (9.5, 17.1)*** |
| 2‐h Postmeal glucose (mg/dL) | ||||
| P/S | 54 | 207.1 (51.3) | 164.3 (41.3) | −42.9 (−52.8, −33.0)*** |
| S/S | 60 | 210.2 (48.8) | 154.7 (34.2) | −55.5 (−66.0, −44.9)*** |
| 2‐h Postmeal insulin (μU/mL) | ||||
| P/S | 54 | 25.4 (14.4) | 27.6 (14.5) | 2.1 (−1.4, 5.7) |
| S/S | 60 | 26.6 (18.2) | 26.8 (15.8) | 0.2 (−2.6, 3.0) |
| 2‐h C‐peptide (ng/mL) | ||||
| P/S | 54 | 4.3 (1.6) | 4.2 (1.6) | −0.1 (−0.4, 0.3) |
| S/S | 60 | 4.2 (1.7) | 3.9 (1.4) | −0.3 (−0.6, −0.1)* |
| Glucose AUC (mg h/dL) | ||||
| P/S | 54 | 384.7 (73.9) | 323.6 (61.5) | −61.1 (−75.8, −46.4)*** |
| S/S | 60 | 383.6 (77.4) | 301.7 (52.0) | −81.8 (−96.7, −66.9)*** |
| Insulin AUC (μU h/mL) | ||||
| P/S | 54 | 39.5 (20.5) | 47.5 (25.1) | 7.9 (3.5, 12.4)*** |
| S/S | 60 | 39.8 (26.2) | 43.7 (26.3) | 3.9 (0.3, 7.6)* |
| C‐peptide AUC (ng h/mL) | ||||
| P/S | 54 | 6.2 (2.3) | 6.3 (2.5) | 0.1 (−0.3, 0.5) |
| S/S | 60 | 5.9 (2.3) | 5.7 (2.1) | −0.2 (−0.5, 0.1) |
| Insulinogenic index (μU/mL)/(mg/dL) | ||||
| P/S | 54 | 0.4 (0.3) | 0.7 (1.0) | 0.3 (0.1, 0.5)** |
| S/S | 60 | 0.5 (0.5) | 0.8 (0.7) | 0.3 (0.1, 0.5)** |
| Active GLP‐1 AUC (pmol h/L) | ||||
| P/S | 54 | 16.0 (0.4) | 33.8 (0.5) | 2.1 (1.9, 2.3)[Link],*** |
| S/S | 59 | 18.0 (0.4) | 37.3 (0.5) | 2.1 (1.9, 2.3)[Link],*** |
| Total GLP‐1 AUC (pmol h/L) | ||||
| P/S | 54 | 26.2 (0.4) | 20.4 (0.4) | 0.8 (0.7, 0.8)[Link],*** |
| S/S | 59 | 27.7 (0.4) | 22.5 (0.4) | 0.8 (0.7, 0.9)[Link],*** |
*P < 0.05, **P < 0.01, ***P < 0.001. †Geometric mean ratio. For parameters related to glucagon‐like peptide‐1 (GLP‐1), the values were log‐transformed before analysis and the back‐transformed results were reported. AUC, total area under the concentration‐versus‐time curve; CI, confidence interval; HbA1c, glycated hemoglobin; HOMA‐β, homeostasis model assessment of β‐cell function; HOMA‐IR, homeostasis model assessment of insulin resistance; P/S, patients who received placebo during the double‐blind period and open‐label sitagliptin in the open‐label period; SD, standard deviation, S/S, patients who received sitagliptin during the double‐blind period and the open‐label period.