Table 4.
Glycemic endpoints measured during meal-tolerance tests at Week 12 for Japanese patients with type 2 diabetes mellitus treated with sitagliptin or placebo added to glinide
| n | Week 0 mean (SD) | Week 12 mean (SD) | Change from Week 0 to Week 12 (LS mean (95 % CI)) | Between-group difference (LS mean (95 % CI)) | |
|---|---|---|---|---|---|
| 2-h postmeal glucose (mg/dL) | |||||
| Placebo | 78 | 214.8 (54.9) | 223.0 (63.6) | 18.7 (−0.4, 37.7) | −51.2 (−67.4, −35.0)*** |
| Sitagliptin | 73 | 224.3 (67.5) | 180.2 (63.0) | −32.5 (−50.1, −14.9) | |
| 2-h postmeal insulin (µU/mL) | |||||
| Placebo | 78 | 51.1 (34.2) | 46.3 (24.3) | −8.6 (−17.7, 0.4) | 2.1 (−4.5, 8.7) |
| Sitagliptin | 73 | 52.0 (34.2) | 48.6 (26.7) | −6.6 (−15.1, 2.0) | |
| Total glucose AUC (mg h/dL) | |||||
| Placebo | 78 | 432.8 (88.9) | 447.2 (100.2) | 42.0 (13.6, 70.4) | −80.6 (−105.2,-56.1)*** |
| Sitagliptin | 73 | 440.6 (100.7) | 376.9 (101.5) | −38.6 (−64.8, −12.5) | |
| Total insulin AUC (µU h/mL) | |||||
| Placebo | 78 | 98.1 (58.0) | 90.5 (47.7) | −10.6 (−20.3, −0.9) | 3.5 (−4.2, 11.2) |
| Sitagliptin | 73 | 96.4 (54.0) | 92.8 (45.3) | −7.1 (−16.2, 1.9) | |
| Total C-peptide AUC (ng h/mL) | |||||
| Placebo | 78 | 7.8 (2.6) | 7.3 (2.3) | −0.8 (−1.3, −0.3) | 0.6 (0.2, 1.0)** |
| Sitagliptin | 73 | 7.8 (2.8) | 7.8 (2.5) | −0.2 (−0.7,0.2) | |
| Insulinogenic index | |||||
| Placebo | 78 | 0.4 (3.5) | 0.7 (0.8) | 0.1 (−1.7, 1.9) | 0.3 (−1.3, 1.8) |
| Sitagliptin | 72 | 1.3 (1.9) | 1.2 (6.7) | 0.4 (−1.3, 2.1) | |
AUC total area under the concentration-versus-time curve, n number of patients who provided measurements at Weeks 0 and 12
*** P < 0.001, ** P < 0.01