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A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8).
- Source :
-
Diabetes, obesity & metabolism [Diabetes Obes Metab] 2016 May; Vol. 18 (5), pp. 475-82. Date of Electronic Publication: 2016 Feb 19. - Publication Year :
- 2016
-
Abstract
- 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.<br />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.<br />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 < 0.001. A greater proportion of participants in the dulaglutide group reached an HbA1c level of <7.0% (53 mmol/mol) compared with placebo (55.3% vs 18.9%; p < 0.001). Dulaglutide significantly decreased fasting serum glucose from baseline compared with placebo (between-group difference -1.86 mmol/l (95% CI -2.58, -1.14) or -33.54 mg/dl (95% CI -46.55, -20.53); p < 0.001. Weight was decreased significantly from baseline in the dulaglutide group (p < 0.001); the between-group difference was not significant. The most common treatment-emergent adverse events for dulaglutide 1.5 mg were gastrointestinal: nausea (10.5%), diarrhoea (8.4%) and eructation (5.9%). Total hypoglycaemia was higher with dulaglutide 1.5 mg vs placebo (2.37 and 0.07 events/participant/year, respectively; p = 0.025). No severe hypoglycaemia was reported.<br />Conclusions: Once-weekly dulaglutide 1.5 mg had a favourable benefit/risk profile when added to glimepiride monotherapy.<br /> (© 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
- Subjects :
- Aged
Diabetes Mellitus, Type 2 blood
Diabetes Mellitus, Type 2 metabolism
Double-Blind Method
Drug Administration Schedule
Drug Resistance
Drug Therapy, Combination adverse effects
Female
Glucagon-Like Peptide-1 Receptor metabolism
Glucagon-Like Peptides administration & dosage
Glucagon-Like Peptides adverse effects
Glucagon-Like Peptides therapeutic use
Glycated Hemoglobin analysis
Humans
Hypoglycemia chemically induced
Hypoglycemia prevention & control
Hypoglycemic Agents administration & dosage
Hypoglycemic Agents adverse effects
Immunoglobulin Fc Fragments administration & dosage
Immunoglobulin Fc Fragments adverse effects
Injections, Subcutaneous
Intention to Treat Analysis
Male
Middle Aged
Patient Dropouts
Recombinant Fusion Proteins administration & dosage
Recombinant Fusion Proteins adverse effects
Sulfonylurea Compounds adverse effects
Diabetes Mellitus, Type 2 drug therapy
Glucagon-Like Peptide-1 Receptor agonists
Glucagon-Like Peptides analogs & derivatives
Hyperglycemia prevention & control
Hypoglycemic Agents therapeutic use
Immunoglobulin Fc Fragments therapeutic use
Recombinant Fusion Proteins therapeutic use
Sulfonylurea Compounds therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1463-1326
- Volume :
- 18
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Diabetes, obesity & metabolism
- Publication Type :
- Academic Journal
- Accession number :
- 26799540
- Full Text :
- https://doi.org/10.1111/dom.12634