Efficacy and Safety Comparison of Liraglutide, Glimepiride, and Placebo, All in Combination With Metformin, in Type 2 Diabetes The LEAD (Liraglutide Effect and Action in Diabetes)-2 study

Michael Nauck, Anders Frid, Kjeld Hermansen, Nalini S. Shah, Tsvetalina Tankova, Ismail H. Mitha, Milan Zdravkovic, Maria During, David R. Matthews

Research output: Chapter in Book/Report/Conference proceedingPaper in conference proceedingpeer-review

916 Citations (SciVal)

Abstract

OBJECTIVE - The efficacy and Safety of adding liraglutide (a glucagon-like peptide-1 receptor agonist) to Metformin were compared with addition of placebo or glimepiride to metformin in subjects previously treated With oral antidiabetes (OAD) therapy. RESEARCH DESIGN AND METHODS - In this 26-week, double-blind, double-dummy, placebo- and active-controlled, parallel-group trial, 1,091 subjects were randomly assigned (2:2:2:1:2) to once-daily liraglutide (either 0.6, 1.2, or 1.8 mg/day injected subcutaneous ), to placebo, or to glimepiride (4 mg once daily). All treatments were in combination therapy with metformin (1g twice daily). Enrolled subjects (aged 25-79 years) had type 2 diabetes, A1C of 7-11% (previous OAD monotherapy for >= 3 months) or 7-10% (previous OAD combination therapy for >= 3 months), and BMI <= 40 kg/m(2). RESULTS - A1C Values were significantly reduced in all liraglutide groups versus the placebo group (P<0.0001) with mean decreases of 1.0% for 1.8 mg liraglutide, 1.2 mg liraglutide and glimepiride and 0.7% for 0.6 mg liraglutide and -,in increase of 0.1% for placebo. Bod weight decreased in all liraglutide groups (1.8-2.8 kg) compared with an increase in the glimepiride group (1.0 kg; P < 0.0001). The incidence of minor hypoglycemia with liraglutide (similar to 3%) was comparable to that, with placebo but less than that with glimepiride (1,7%; P < 0.001). Nausea was reported by 11-19% of the liraglutide-treated subjects versus 3-4% in the placebo and glimepiride groups. The incidence of nausea declined over time. CONCLUSIONS - In subjects with type 2 diabetes, once-daily liraglutide induced similar glycemic control, reduced body weight, and lowered the Occurrence of hypoglycemia compared with glimepiride, when both had background therapy of metformin.
Original languageEnglish
Title of host publicationDiabetes Care
PublisherAmerican Diabetes Association
Pages84-90
Volume32
DOIs
Publication statusPublished - 2009
Event68th Annual Meeting of the American-Diabetes-Association - San Francisco, CA
Duration: 2008 Jun 62008 Jun 10

Publication series

Name
Number1
Volume32
ISSN (Print)0149-5992

Conference

Conference68th Annual Meeting of the American-Diabetes-Association
Period2008/06/062008/06/10

Bibliographical note

The information about affiliations in this record was updated in December 2015.
The record was previously connected to the following departments: Endocrinology (013241500), Pediatrics/Urology/Gynecology/Endocrinology (013240400)

Subject classification (UKÄ)

  • Endocrinology and Diabetes

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