From: Safety and tolerability of sitagliptin in patients with type 2 diabetes: a 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 |