Efficacy and safety of once-weekly GLP-1 receptor agonist albiglutide (HARMONY 2): 52 week primary endpoint results from a randomised, placebo-controlled trial in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise

• Published in: Diabetologia 2016-02, Vol.59 (2), p.266-274
• Main Authors: Nauck, Michael A., Stewart, Murray W., Perkins, Christopher, Jones-Leone, Angela, Yang, Fred, Perry, Caroline, Reinhardt, Rickey R., Rendell, Marc
• Format: Article
• Language: English
• Subjects: Adult; Aged; Biomarkers - analysis; Biomarkers - blood; Clinical medicine; Diabetes; Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - therapy; Diet; Exercise - physiology; Female; Follow-Up Studies; Glucagon; Glucagon-Like Peptide 1 - administration & dosage; Glucagon-Like Peptide 1 - adverse effects; Glucagon-Like Peptide 1 - analogs & derivatives; Glucagon-Like Peptide-1 Receptor - agonists; Glucose; Glycated Hemoglobin A - analysis; Human Physiology; Humans; Hypoglycemia; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - adverse effects; Internal Medicine; Male; Medicine; Medicine & Public Health; Metabolic Diseases; Middle Aged; Patients; Peptides; Treatment Outcome
• ISSN: 0012-186X; 1432-0428
• DOI: 10.1007/s00125-015-3795-1

Aims/hypothesis Additional safe and effective therapies for type 2 diabetes are needed, especially ones that do not cause weight gain and have a low risk of hypoglycaemia. The present study evaluated albiglutide as monotherapy. Methods In this placebo-controlled study, 309 patients (aged ≥18 years) with type 2 diabetes inadequately controlled by diet and exercise and who were not using a glucose-lowering agent (HbA 1c 7.0–10.0% [53.00–85.79 mmol/mol], body mass index 20–45 kg/m 2 , and fasting C-peptide ≥0.26 nmol/l) were randomised (1:1:1 on a fixed randomisation schedule using an interactive voice response system) to receive once-weekly albiglutide 30 mg ( n  = 102) or 50 mg ( n  = 102) or matching placebo ( n  = 105). The study treatments were blinded to both patients and study personnel. All study data were collected at individual patient clinic visits. The primary efficacy endpoint was change in HbA 1c from baseline to week 52. The primary analysis was applied to the intent-to-treat population. Additional efficacy and safety endpoints were assessed. Results At week 52, both albiglutide 30 mg and 50 mg were superior to placebo in reducing HbA 1c . The least-squares means treatment difference from placebo was −0.84% (95% CI −1.11%, −0.58%; p