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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.