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Table 1 Studies and treatment arms included in this pooled analysis

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
  1. *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.