A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8)

• Published in: Diabetes, obesity & metabolism obesity & metabolism, 2016-05, Vol.18 (5), p.475-482
• Main Authors: Dungan, K. M., Weitgasser, R., Perez Manghi, F., Pintilei, E., Fahrbach, J. L., Jiang, H. H., Shell, J., Robertson, K. E.
• Format: Article
• Language: English
• Subjects: Aged; Confidence intervals; Diabetes; Diabetes mellitus; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - metabolism; Diarrhea; Double-Blind Method; Drug Administration Schedule; Drug Resistance; Drug Therapy, Combination - adverse effects; dulaglutide; Female; GLP-1 receptor agonists; Glucagon; Glucagon-like peptide 1; Glucagon-Like Peptide-1 Receptor - agonists; Glucagon-Like Peptide-1 Receptor - metabolism; Glucagon-Like Peptides - administration & dosage; Glucagon-Like Peptides - adverse effects; Glucagon-Like Peptides - analogs & derivatives; Glucagon-Like Peptides - therapeutic use; Glycated Hemoglobin A - analysis; Hemoglobin; Humans; Hyperglycemia - prevention & control; Hypoglycemia; Hypoglycemia - chemically induced; Hypoglycemia - prevention & control; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; Immunoglobulin Fc Fragments - administration & dosage; Immunoglobulin Fc Fragments - adverse effects; Immunoglobulin Fc Fragments - therapeutic use; Injections, Subcutaneous; Intention to Treat Analysis; Male; Middle Aged; Motivation; Nausea; Original; Patient Dropouts; Recombinant Fusion Proteins - administration & dosage; Recombinant Fusion Proteins - adverse effects; Recombinant Fusion Proteins - therapeutic use; Safety; Sulfonylurea Compounds - adverse effects; Sulfonylurea Compounds - therapeutic use; type 2 diabetes
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.12634

Aims To evaluate the safety and efficacy of once‐weekly dulaglutide 1.5 mg, a long‐acting glucagon‐like peptide‐1 receptor agonist, compared with placebo in patients with type 2 diabetes (T2D) on glimepiride monotherapy. Methods This phase III, randomized (4 : 1; dulaglutide:placebo), double‐blind, placebo‐controlled, 24‐week study compared the safety and efficacy of once‐weekly dulaglutide 1.5 mg with placebo in sulphonylurea‐treated (≥half‐maximal dose, stable ≥3 months) patients (N = 300) with T2D and inadequate glycaemic control [glycated haemoglobin (HbA1c) ≥7.5 and ≤9.5% (≥58 mmol/mol and ≤80 mmol/mol)]. Analysis was carried out according to intention‐to‐treat. Results At baseline, the mean participant age was 58 years; mean HbA1c was 8.4% (68 mmol/mol) and mean weight was 85.5 kg. Dulaglutide 1.5 mg was superior to placebo at 24 weeks for HbA1c reduction from baseline with a between‐group HbA1c difference of −1.3% [95% confidence interval (CI) −1.6, −1.0] or ‐14 mmol/mol (95% CI −17, −11); p