Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes

A randomized, placebo-controlled trial

on behalf of the NN2211-3917 Study Group

Research output: Contribution to journalArticle

50 Citations (Scopus)

Abstract

Aim: To confirm the superiority, compared with placebo, of adding liraglutide to pre-existing basal insulin analogue±metformin in adults with inadequately controlled type 2 diabetes [glycated haemoglobin (HbA1c) 7.0-10.0% (53-86mmol/mol)]. Methods: In this 26-week, double-blind, parallel-group study, conducted in clinics or hospitals, 451 subjects were randomized 1:1 to once-daily liraglutide 1.8mg (dose escalated from 0.6 and 1.2mg/day, respectively, for 1week each; n=226) or placebo (n=225) added to their pre-existing basal insulin analogue (≥20U/day)±metformin (≥1500mg/day). After randomization, insulin adjustments above the pre-study dose were not allowed. The primary endpoint was HbA1c change. Results: After 26weeks, HbA1c decreased more with liraglutide [-1.3% (-14.2mmol/mol)] than with placebo [-0.1% (-1.2mmol/mol); p

Original languageEnglish (US)
Pages (from-to)1056-1064
Number of pages9
JournalDiabetes, Obesity and Metabolism
Volume17
Issue number11
DOIs
StatePublished - Nov 1 2015

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Metformin
Type 2 Diabetes Mellitus
Randomized Controlled Trials
Placebos
Insulin
Safety
Glycosylated Hemoglobin A
Random Allocation
Liraglutide

Keywords

  • GLP-1 analogue
  • Glycaemic control
  • Incretin therapy
  • Insulin therapy
  • Randomised trial
  • Weight loss therapy

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

Cite this

Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes : A randomized, placebo-controlled trial. / on behalf of the NN2211-3917 Study Group.

In: Diabetes, Obesity and Metabolism, Vol. 17, No. 11, 01.11.2015, p. 1056-1064.

Research output: Contribution to journalArticle

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