ONGLYZA® (saxagliptin)

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Study details: Nowicki et al. 2011

This was a 12-week, phase 3, randomised, parallel-group, placebo-controlled, double-blind international, multi-centre trial with a 40-week extension period.The aim of the study was to assess the efficacy and safety of saxagliptin vs. placebo in adults with type 2 diabetes mellitus and inadequate glycaemic control (HbA1c 7-11%) and moderate or severe renal impairment, or end-stage renal disease (ESRD).

Using CrCI estimated by the Cockcroft-Gault equation, eligible patients (n=170) were stratified based on degree of renal impairment, and randomised (1:1) in balanced blocks within each renal impairment category to double-blind treatment with saxagliptin 2.5 mg (n=85) or placebo (n=85) once daily. Other antidiabetic drugs in use at enrolment were continued, subject to adjustment as needed to prevent hypoglycaemia through the 52-week study or to improve glycaemic control during the 40-week extension; addition of new drugs except thiazolidinediones, glucagon-like peptide 1 (GLP-1) agonists, metformin and other DPP-4 inhibitors was allowed.

Efficacy was assessed by absolute changes from baseline to week 12 HbA1c (primary end-point) and FPG (secondary end-point).The percentage of patients achieving a therapeutic glycaemic response (defined as >0.5% decrease in HbA1C) in each treatment group was also determined.

The primary efficacy end-point was absolute HbA1c change from baseline to week 12. Secondary end-points included assessment of efficacy at 52 weeks using absolute change from baseline in HbA1c and fasting plasma glucose and changes from baseline in the type and/or daily doses of background oral antidiabetic drug therapy and insulin.
A total of 170 patients were randomised. Of these, 129 (76%) completed the 12-week short-term treatment period and 92 (54%) completed the 52-week study (saxagliptin, 49%; placebo, 59%).