Lixisenatide treatment improves glycaemic control in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea: a randomized, double-blind, placebo-controlled, 24-week trial (GetGoal-M-Asia).

Abstract

BACKGROUND:

This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea.

METHODS:

In this 24-week, double-blind, placebo-controlled, multinational study, patients were randomized to lixisenatide 20 µg once daily or placebo. The primary endpoint was absolute change in glycated haemoglobin (HbA1c ) from baseline to week 24.

RESULTS:

A total of 391 patients were randomized. Lixisenatide significantly reduced HbA1c levels compared with placebo (LS mean difference: -0.36%, p = 0.0004). A significantly higher proportion of lixisenatide-treated patients achieved HbA1c targets of <7% (p = 0.003) and ≤6.5% (p = 0.001) versus placebo. Lixisenatide was associated with a statistically significant reduction in 2-h postprandial plasma glucose after a standardized breakfast versus placebo (LS mean difference: -4.28 mmol/L, p < 0.0001) and a significant reduction in fasting plasma glucose (p = 0.0109). There was no difference in weight loss versus placebo, with a modest reduction in body weight reported for both groups (lixisenatide: -1.50 kg, placebo: -1.24 kg; p = 0.296). The incidence of treatment-emergent adverse events (TEAEs) was 64.3% with lixisenatide versus 47.4% with placebo, with serious TEAEs reported in 1.5% versus 2.1% of patients, respectively. The most common TEAE in the lixisenatide group was nausea (16.3% vs 2.6% with placebo). The incidence of symptomatic hypoglycaemia was 5.6% with lixisenatide treatment and 2.6% with placebo (p = 0.1321), with no severe symptomatic hypoglycaemia events reported.

CONCLUSIONS:

In Asian patients with type 2 diabetes mellitus insufficiently controlled on metformin ± sulfonylurea, lixisenatide significantly improved glycaemic control and was well tolerated during the 24-week study.

• Authors: Chang Yu Pan, Ping Han, Xiaoming Liu, Shengli Yan, Ping Feng, Zhiguang Zhou, Xiaofeng Lv, Hui Tian, Yang Jin Kui, Benli Su, Shuhua Shang, Elisabeth Niemoeller
• Journal: Diabetes/metabolism research and reviews (Diabetes Metab Res Rev) Vol. 30 Issue 8 Pg. 726-35 (Nov 2014) ISSN: 1520-7560 [Electronic] England
• PMID: 24639432 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons, Ltd.

Chemical References

• GLP1R protein, human
• Glucagon-Like Peptide-1 Receptor
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Peptides
• Receptors, Glucagon
• Sulfonylurea Compounds
• hemoglobin A1c protein, human
• lixisenatide
• Metformin

Topics

• Adult
• China
• Diabetes Mellitus, Type 2 (blood, drug therapy, metabolism)
• Double-Blind Method
• Drug Resistance
• Drug Resistance, Multiple
• Drug Therapy, Combination (adverse effects)
• Female
• Glucagon-Like Peptide-1 Receptor
• Glycated Hemoglobin (analysis)
• Humans
• Hyperglycemia (prevention & control)
• Hypoglycemia (chemically induced)
• Hypoglycemic Agents (adverse effects, therapeutic use)
• Malaysia
• Male
• Metformin (adverse effects, therapeutic use)
• Middle Aged
• Nausea (chemically induced)
• Peptides (adverse effects, therapeutic use)
• Receptors, Glucagon (agonists, metabolism)
• Sulfonylurea Compounds (adverse effects, therapeutic use)
• Thailand