|
Overall disposition of the 6139 randomized patients in the sitagliptin and non-exposed groups |
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| Sitagliptin 100 mg |
Non-Exposed |
|
|
|
||
| RANDOMIZED, N |
3415 |
2724 |
|
|
||
|
|
||
| n (%) |
n (%) |
|
|
|
||
| DISCONTINUED* |
1191 (34.9) |
1076 (39.5) |
|
|
||
| Reason for discontinuation |
||
|
|
||
| Clinical adverse experience |
119 (3.5) |
113 (4.1) |
|
|
||
| Laboratory adverse experience |
38 (1.1) |
22 (0.8) |
|
|
||
| Lack of efficacy† |
458 (13.4) |
381 (14.0) |
|
|
||
| Patient discontinued for other |
152 (4.5) |
176 (6.5) |
|
|
||
| Patient moved |
33 (1.0) |
19 (0.7) |
|
|
||
| Patient withdrew consent |
186 (5.4) |
203 (7.4) |
|
|
||
| Protocol specified discontinuation criteria |
48 (1.4) |
44 (1.6) |
|
|
||
| Protocol deviation |
58 (1.7) |
50 (1.8) |
|
|
||
| Lost to follow-up |
97 (2.8) |
65 (2.4) |
|
|
||
| Site terminated |
2 (0.1) |
3 (0.1) |
|
*To provide a complete accounting of the 6139 randomized patients, this table includes data from patients after they received glycemic rescue therapy, whereas the primary safety analysis focuses on results excluding data after patients received rescue therapy. These numbers include patients discontinued over periods of up to 2 years, including those patients who underwent glycemic rescue during the placebo-controlled phase and were ineligible in some studies to enter into the continuation phase. †Includes patients not meeting the progressively stricter, protocol-specified, glycemic rescue criteria and/or not meeting the investigator's expectations of glycemic improvement. | ||
Williams-Herman et al. BMC Endocrine Disorders 2008 8:14 doi:10.1186/1472-6823-8-14 |
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