Table 1 |
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|
Studies and treatment arms included in the primary analysis |
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|
Study |
Study Design |
Sitagliptin 100 mg/day Group (N = 5429) |
n |
Non-exposed Group (N = 4817) |
n |
Reference* |
|
|
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|
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] |
|
|
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|
*References are for the initial phases of the studies that had extension or continuation phases, unless a reference is provided for the results beyond the initial phase. q.d. = once daily; b.i.d. = twice daily |
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|
Williams-Herman et al. BMC Endocrine Disorders 2010 10:7 doi:10.1186/1472-6823-10-7 |
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