Table 1 Studies and treatment arms included in the primary analysis
Study | Study Design | Sitagliptin 100 mg/day Group (N = 5429) | n | Non-exposed Group (N = 4817) | n | Reference* |
|---|---|---|---|---|---|---|
P010: twice-daily dose-range finding study | 106-week active-controlled period | Sitagliptin 50 mg b.i.d. switched to Sitagliptin 100 mg q.d. | 122 | Glipizide | 123 | [11] |
P014: once-daily dose-range finding study | 12-week placebo-controlled period and 94-week active- controlled period | -Sitagliptin 100 mg q.d. -Sitagliptin 50 mg b.i.d. switched to Sitagliptin 100 mg q.d. | 110 111 | Placebo (12 weeks) switched to metformin (94 weeks) | 111 | [12] |
P019: placebo-controlled add-on to pioglitazone study | 24-week placebo-controlled period | Sitagliptin 100 mg q.d. + pioglitazone | 175 | Placebo + pioglitazone | 178 | [48] |
P020: placebo-controlled add-on to metformin study | 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 | [49] |
P021: placebo-controlled monotherapy study | 24-week placebo-controlled period | Sitagliptin 100 mg q.d. | 238 | Placebo | 253 | [50] |
P023: placebo-controlled monotherapy study | 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 | [51] |
P024: active-comparator controlled add-on to metformin study | 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 study | 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 | [25] |
P036: placebo- and active-controlled study of initial combination use of sitagliptin and metformin | 24-week placebo-controlled period; 80-week active-controlled period | -Sitagliptin 100 mg q.d. -Sitagliptin 50 mg b.i.d./metformin 500 mg b.i.d. -Sitagliptin 50 mg b.i.d./metformin 1000 mg b.i.d. | 179 190 182 | -Placebo (24 weeks) switched to metformin (80 weeks) -Metformin 500 mg b.i.d. -Metformin 1000 mg b.i.d. | 176 182 182 | |
P040: placebo-controlled monotherapy study | 18-week placebo-controlled period | Sitagliptin 100 mg q.d. | 352 | Placebo | 178 | [54] |
P047: placebo-controlled monotherapy study in elderly patients | 24-week placebo-controlled period | Sitagliptin 100 mg q.d | 91 | Placebo | 92 | [55] |
P049: active-comparator controlled monotherapy study | 24-week active-controlled period | Sitagliptin 100 mg q.d | 528 | Metformin | 522 | [56] |
P051: placebo-controlled add-on to insulin, alone or in combination with metformin study | 24-week placebo-controlled period | Sitagliptin 100 mg q.d + insulin (± metformin) | 322 | Placebo + insulin ± metformin | 319 | [26] |
P052: placebo-controlled add-on to metformin and rosiglitazone study | 54-week placebo-controlled period | Sitagliptin 100 mg q.d. + metformin and rosiglitazone | 170 | Placebo + metformin and rosiglitazone | 92 | [57] |
P053: placebo-controlled add-on to metformin study | 30-week placebo-controlled period | Sitagliptin 100 mg q.d. + metformin | 96 | Placebo + metformin | 94 | [58] |
P061: placebo- and active-controlled mechanism of action factorial study | 12-week placebo-controlled period | -Sitagliptin 100 mg q.d. -Sitagliptin 100 mg q.d. + pioglitazone | 52 52 | -Pioglitazone -Placebo | 54 53 | [28] |
P064: active-comparator controlled study of initial combination use of sitagliptin and pioglitazone | 54-week active-controlled period | Sitagliptin 100 mg q.d + pioglitazone | 261 | Placebo + pioglitazone | 259 | [29] |
P079: active-comparator controlled study of initial combination use of sitagliptin/metformin FDC (MK-0431A) | 44-week active-controlled period | Sitagliptin 50 mg + metformin 1000 mg b.i.d. (FDC) | 625 | Metformin 1000 mg b.i.d. | 621 | |
P801: placebo- and active-controlled add-on to metformin study | 18-week placebo-controlled period | Sitagliptin 100 mg q.d. | 94 | -Rosiglitazone -Placebo | 87 91 | [59] |