Dapagliflozin monotherapy in drug-naïve patients with diabetes: a randomized-controlled trial of low-dose range

C.J. Bailey, N. Iqbal, C. T'joen, J.F. List

Research output: Contribution to journalArticlepeer-review

Abstract

Aims: Many patients with type 2 diabetes are suboptimally managed with currently available therapies. Dapagliflozin, a sodium-glucose co-transporter-2 inhibitor, has shown efficacy in reducing diabetic hyperglycaemia. This study assessed efficacy of three lower doses in recently diagnosed patients. Methods: This phase 3, randomized, double-blind, placebo-controlled study assigned treatment-naïve patients to placebo or dapagliflozin monotherapy (1, 2.5 or 5 mg) daily for 24 weeks. Patients were antidiabetic drug-naïve with inadequate glycaemic control [haemoglobin A1c (HbA1c) =7.0 and =10.0%]. The primary efficacy endpoint was change in HbA1c from baseline. Secondary endpoints included changes in body weight and fasting plasma glucose (FPG), and proportions achieving HbA1c
Original languageEnglish
Pages (from-to)951-959
Number of pages9
JournalDiabetes, Obesity and Metabolism
Volume14
Issue number10
DOIs
Publication statusPublished - Oct 2012

Keywords

  • dapagliflozin
  • diabetes mellitus
  • glycaemic control
  • SGLT2
  • sodium-glucose co-transporter 2
  • type 2 diabetes

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