Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36‐week, randomized, double‐blind, parallel‐group trial

Aims/Introduction To assess efficacy and safety of liraglutide in combination with insulin compared with insulin monotherapy in Japanese patients with type 2 diabetes. Materials and methods This was a 36‐week, multicenter, double‐blind, parallel‐group trial, where patients on stable insulin therapy...

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Published in:Journal of diabetes investigation 2016-07, Vol.7 (4), p.565-573
Main Authors: Seino, Yutaka, Kaneko, Shizuka, Fukuda, Shuichi, Osonoi, Takeshi, Shiraiwa, Toshihiko, Nishijima, Keiji, Bosch‐Traberg, Heidrun, Kaku, Kohei
Format: Article
Language:English
Subjects:
Advisors
Aged
Antidiabetics
Blood Glucose - drug effects
Body mass index
Body Weight - drug effects
Clinical medicine
Clinical Trial
Diabetes
Diabetes mellitus
Diabetes mellitus (non-insulin dependent)
Diabetes Mellitus, Type 2 - drug therapy
Diabetes Mellitus, Type 2 - metabolism
Double-Blind Method
Double-blind studies
Drug Therapy, Combination
Female
Glucose
Glycated Hemoglobin A - analysis
Hemoglobin
Humans
Hypoglycemia
Hypoglycemic Agents - adverse effects
Hypoglycemic Agents - therapeutic use
Insulin
Insulin - adverse effects
Insulin - therapeutic use
Liraglutide
Liraglutide - adverse effects
Liraglutide - therapeutic use
Male
Middle Aged
Pharmaceuticals
Public speaking
Studies
Treatment Outcome
Type 2 diabetes mellitus
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Summary:Aims/Introduction To assess efficacy and safety of liraglutide in combination with insulin compared with insulin monotherapy in Japanese patients with type 2 diabetes. Materials and methods This was a 36‐week, multicenter, double‐blind, parallel‐group trial, where patients on stable insulin therapy (basal/premixed/basal–bolus) were randomized 1:1 to additional liraglutide 0.9 mg/day (n = 127) or placebo (n = 130). The insulin dose was fixed for 16 weeks, and titrated based on self‐measured plasma glucose thereafter. The primary end‐point was change in glycosylated hemoglobin after 16 weeks. Results Superiority of liraglutide plus insulin versus insulin monotherapy was confirmed based on estimated mean difference in glycosylated hemoglobin after 16 weeks of −1.30% (−14 mmol/mol; 95% confidence interval −1.47 to −1.13 [−16, −12]; P < 0.0001). Statistical significance was maintained to week 36. More patients on liraglutide achieved a glycosylated hemoglobin target of
ISSN:2040-1116
2040-1124
DOI:10.1111/jdi.12457