|
Studies and treatment arms included in this pooled analysis |
|||||
| Study and Reference* |
Study Design |
Sitagliptin 100 mg/day Group (N = 3415) |
n |
Non-exposed Group (N = 2724) |
n |
|
|
|||||
| P010: twice-daily dose-range finding [6] |
106-week active-controlled period |
• Sitagliptin 50 mg b.i.d. switched to 100 mg q.d. |
122 |
• Glipizide |
123 |
|
|
|||||
| P014: once-daily dose-range finding [8] |
12-week placebo-controlled period and 94-week active-controlled period |
• Sitagliptin 100 mg q.d. |
110 |
• Placebo (12 weeks) switched to metformin (94 weeks) |
111 |
| • Sitagliptin 50 mg b.i.d. switched to Sitagliptin 100 mg q.d. |
111 |
||||
|
|
|||||
| P019: placebo-controlled add-on to pioglitazone study [11] |
24-week placebo-controlled period |
• Sitagliptin 100 mg q.d. + pioglitazone |
175 |
• Placebo + pioglitazone |
178 |
|
|
|||||
| P020: placebo-controlled add-on to metformin study [9] |
24-week placebo-controlled period and 80-week active-controlled period |
• Sitagliptin 100 mg q.d. + metformin |
464 |
• Placebo + metformin (24 weeks) switched to glipizide + metformin (80 weeks) |
237 |
|
|
|||||
| P021: placebo-controlled monotherapy study [4] |
24-week placebo-controlled period |
• Sitagliptin 100 mg q.d. |
238 |
• Placebo |
253 |
|
|
|||||
| P023: placebo-controlled |
18-week placebo-controlled period and 36-week active-controlled period |
• Sitagliptin 100 mg q.d. |
205 |
• Placebo (18 weeks) switched to pioglitazone (36 weeks) |
110 |
|
|
|||||
| P024: active-comparator controlled add-on to metformin study [14] |
104-week active-controlled period |
• Sitagliptin 100 mg q.d. + metformin |
588 |
• Glipizide + metformin |
584 |
|
|
|||||
| P035: placebo-controlled add-on to glimepiride, alone or in combination with metformin [10] |
24-week placebo-controlled period and 30-week active-controlled period |
• Sitagliptin 100 mg q.d. + glimepiride (± metformin) |
222 |
• Placebo + glimepiride (± metformin) (24 weeks) switched to pioglitazone + glimepiride (± metformin) (30 weeks) |
219 |
|
|
|||||
| P036: placebo- and active-controlled study of initial combination use of metformin and sitagliptin[12] |
24 week placebo-controlled period and 30-week active-controlled period |
• Sitagliptin 100 mg q.d. |
179 |
• Placebo (24 weeks) switched to metformin 1000 mg b.i.d. (30 weeks) |
176 |
| • Sitagliptin 50 mg b.i.d./metformin 500 mg b.i.d. |
190 |
• Metformin 500 mg b.i.d. |
182 |
||
| • Sitagliptin 50 mg b.i.d./metformin 1000 mg b.i.d. |
182 |
• Metformin 1000 mg b.i.d. |
182 |
||
|
|
|||||
| P040: placebo-controlled monotherapy study [39] |
18-week placebo-controlled period |
• Sitagliptin 100 mg q.d. |
352 |
• Placebo |
178 |
|
|
|||||
| P052: placebo-controlled add-on to metformin and rosiglitazone study [40] |
18-week placebo-controlled period |
• Sitagliptin 100 mg q.d. + metformin and rosiglitazone |
181 |
• Placebo + metformin and rosiglitazone |
97 |
|
|
|||||
| P053: placebo-controlled add-on to metformin study [13] |
30-week placebo-controlled period |
• Sitagliptin 100 mg q.d. + metformin |
96 |
• Placebo + metformin |
94 |
|
*References are for the initial phases of the studies that had extension or continuations phases. Studies P019, P040, and P053 did not have continuation phases. For Studies P052, patients continued their sitagliptin or placebo treatment in the currently ongoing continuation phase. | |||||
Williams-Herman et al. BMC Endocrine Disorders 2008 8:14 doi:10.1186/1472-6823-8-14 |
|||||