Comparison of empagliflozin and glimepiride as add-on to metformin in patients with type 2 diabetes: A 104-week randomised, active-controlled, double-blind, phase 3 trial

  • Ridderstråle M
  • Andersen K
  • Zeller C
 et al. 
  • 99

    Readers

    Mendeley users who have this article in their library.
  • 145

    Citations

    Citations of this article.

Abstract

Background: Metformin is the recommended first-line pharmacotherapy for patients with type 2 diabetes. There is no consensus on the optimum second-line pharmacotherapy. We compared the efficacy and safety of the sodium glucose cotransporter 2 inhibitor empagliflozin and the sulfonylurea glimepiride as add-on to metformin in patients with type 2 diabetes. Methods: In this double-blind phase 3 trial, patients (aged ≥18 years) with type 2 diabetes and HbA1cconcentrations of 7-10%, despite metformin treatment and diet and exercise counselling, were randomly assigned in a 1:1 ratio with a computer-generated random sequence, stratified by HbA1c, estimated glomerular filtration rate (eGFR), and region, to empagliflozin (25 mg once daily, orally) or glimepiride (1-4 mg once daily, orally) as add-on to metformin for 104 weeks. Patients and investigators were masked to treatment assignment. The primary endpoint was change from baseline in HbA1clevels at weeks 52 and 104. Differences in the primary endpoint were first tested for non-inferiority (based on a margin of 0·3%). If non-inferiority was shown, differences in the primary endpoint at week 104 were then tested for superiority. Analysis was done on the full-analysis set-ie, patients who were treated with at least one dose of study drug and had a baseline HbA1cvalue. This study is registered with ClinicalTrials.gov, number NCT01167881. A 104-week extension is ongoing.

Get free article suggestions today

Mendeley saves you time finding and organizing research

Sign up here
Already have an account ?Sign in

Find this document

Get full text

Authors

  • Martin Ridderstråle

  • Knut Robert Andersen

  • Cordula Zeller

  • Gabriel Kim

  • Hans J. Woerle

  • Uli C. Broedl

Cite this document

Choose a citation style from the tabs below

Save time finding and organizing research with Mendeley

Sign up for free