Saxagliptin Added to a Thiazolidinedione Improves Glycemic Control in Patients with Type 2 Diabetes and Inadequate Control on Thiazolidinedione Alone

Context: Due to the natural progression of type 2 diabetes (T2D), most patients require combination therapy to maintain glycemic control. Objective: Our objective was to evaluate efficacy and safety of saxagliptin plus thiazolidinedione (TZD) in patients with T2D and inadequate glycemic control on TZD monotherapy. Design: The study was a multicenter, randomized, double-blind, placebo (PBO)-controlled phase 3 trial conducted from March 13, 2006, to October 15, 2007. Setting: Patients were recruited from 172 outpatient centers. Patients: Patients with inadequately controlled T2D [glycosylated hemoglobin (HbA1c) 7.0–10.5%], 18–77 yr, receiving stable TZD monotherapy (pioglitazone 30 or 45 mg or rosiglitazone 4 or 8 mg) for at least 12 wk before screening were eligible. Interventions: A total of 565 patients were randomized and treated with saxagliptin (2.5 or 5 mg) or PBO, once daily, plus stable TZD dose for 24 wk. Main Outcome Measures: Primary outcome was change in HbA1c from baseline to wk 24. Secondary ...