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Table 2 Overall disposition of the 6139 randomized patients in the sitagliptin and non-exposed groups

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

  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)
  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.
  2. Includes patients not meeting the progressively stricter, protocol-specified, glycemic rescue criteria and/or not meeting the investigator's expectations of glycemic improvement.