Monotherapy with the once weekly GLP-1 receptor agonist dulaglutide for 12 weeks in Japanese patients with type 2 diabetes: dose-dependent effects on glycaemic control in a randomised, double-blind, placebo-controlled study

The aim of this study was to evaluate the dose-dependent effect of dulaglutide, a glucagon-like peptide-1 receptor agonist, on glycaemic control in Japanese patients with type 2 diabetes mellitus who were treated with diet/exercise or oral antidiabetic drug monotherapy. In this randomised, double-bl...

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Bibliographic Details
Published in:Endocrine Journal 2014, Vol.61(10), pp.949-959
Main Authors: Terauchi, Yasuo, Satoi, Yoichi, Takeuchi, Masakazu, Imaoka, Takeshi
Format: Article
Language:English
Subjects:
Adult
Blood Glucose - analysis
Diabetes Mellitus, Type 2 - blood
Diabetes Mellitus, Type 2 - drug therapy
Dose-response
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Dulaglutide
Female
Glucagon-Like Peptide-1 Receptor
Glucagon-Like Peptides - administration & dosage
Glucagon-Like Peptides - analogs & derivatives
Glucagon-Like Peptides - therapeutic use
Humans
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - therapeutic use
Immunoglobulin Fc Fragments - administration & dosage
Immunoglobulin Fc Fragments - therapeutic use
Japanese
Male
Middle Aged
Receptors, Glucagon - agonists
Recombinant Fusion Proteins - administration & dosage
Recombinant Fusion Proteins - therapeutic use
Treatment Outcome
Type 2 diabetes mellitus
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Summary:The aim of this study was to evaluate the dose-dependent effect of dulaglutide, a glucagon-like peptide-1 receptor agonist, on glycaemic control in Japanese patients with type 2 diabetes mellitus who were treated with diet/exercise or oral antidiabetic drug monotherapy. In this randomised, double-blind, placebo-controlled, parallel-group, 12-week study, patients received once weekly subcutaneous dulaglutide doses of 0.25, 0.5, or 0.75 mg (DU 0.25, DU 0.5, and DU 0.75, respectively) or placebo (n=36, 37, 35, and 37, respectively). The primary measure was change from baseline in glycated haemoglobin (HbA1c; %) at 12 weeks. Continuous variables were analysed using a mixed-effects model for repeated measures. Significant dose-dependent reductions in HbA1c were observed (least squares mean difference versus placebo [95% confidence interval]): DU 0.25=-0.72% (-0.95, -0.48), DU 0.5=-0.97% (-1.20, -0.73), and DU 0.75=-1.17% (-1.41, -0.93); p
ISSN:0918-8959
1348-4540
DOI:10.1507/endocrj.EJ14-0147