In a clinical trial of patients with inadequate glycemic control on diet, exercise and Metformin monotherapy greater than 1500 mg/day, patients were randomized in a double-blind manner to the addition of Sitagliptin 100 mg once daily or the sulfonylurea Glipizide 5-20 mg/day ( mean daily dose 10 mg daily ) for 52 weeks. In this study, Sitagliptin achieved the pre-specified bounds for non-inferiority vs. a sulfonylurea ( Glipizide ). After 52 weeks, the mean A1C reduction from baseline was 0.5 percent for Sitagliptin ( n=576 ) and 0.6% for Glipizide ( n=559 ) in the intent-to-treat patient population and 0.7% for Sitagliptin and 0.7% for Glipizide in the per protocol analysis, confirming the similar mean A1C reductions of Sitagliptin compared to Glipizide. At 52 weeks, mean body weight decreased with the addition of Sitagliptin ( -1.5 kg ) and increased with the addition of glipizide ( 1.1 kg ), a significant difference of 2.5 kg ( -3.1, -2.0; p less than 0.001 ) or 5.5 pounds. Additionally, patients treated with Sitagliptin experienced a significantly lower incidence of hypoglycemia than patients treated with Glipizide ( 4.9 vs. 32.0%, respectively, p less than 0.001 ). A conclusion in favor of the non-inferiority of Sitagliptin to Glipizide may be limited to patients with baseline A1C comparable to those included in the study.

Source: Merck, 2011

XagenaMedicine2011