Efficacy and Safety Comparison of Liraglutide, Glimepiride, and Placebo, All in Combination With Metformin, in Type 2 Diabetes

• DOI: 10.2337/dc08-1355
• Publication Date: 2008-10-17T20:59:31Z
• Authors: Michael Nauck; Anders Frid; Kjeld Hermansen; Nalini S. Shah; Tsvetalina Tankova; Ismail H. Mitha; Milan Zdravkovic; Maria Düring; David R. Matthews
• Keywords: Glimepiride

OBJECTIVE—The efficacy and safety of adding liraglutide (a glucagon-like peptide-1 receptor agonist) to metformin were compared with addition placebo or glimepiride in subjects previously treated oral antidiabetes (OAD) therapy. RESEARCH DESIGN AND METHODS—In this 26-week, double-blind, double-dummy, placebo- active-controlled, parallel-group trial, 1,091 randomly assigned (2:2:2:1:2) once-daily (either 0.6, 1.2, 1.8 mg/day injected subcutaneously), placebo, (4 mg once daily). All treatments combination therapy (1g twice Enrolled (aged 25–79 years) had type 2 diabetes, A1C 7–11% (previous OAD monotherapy for ≥3 months) 7–10% months), BMI ≤40 kg/m2. RESULTS—A1C values significantly reduced all groups versus the group (P < 0.0001) mean decreases 1.0% liraglutide, 1.2 0.7% 0.6 an increase 0.1% placebo. Body weight decreased (1.8–2.8 kg) (1.0 kg; P 0.0001). The incidence minor hypoglycemia (∼3%) was comparable that but less than (17%; 0.001). Nausea reported by 11–19% liraglutide-treated 3–4% groups. nausea declined over time. CONCLUSIONS—In induced similar glycemic control, body weight, lowered occurrence glimepiride, when both background metformin.