Abstract | INTRODUCTION: METHODS: This was a randomised, double-blind, parallel-group phase 4 trial of empagliflozin (10 mg or 25 mg) for 52 weeks as an add-on therapy to liraglutide (0.9 mg/day) in Japanese patients with T2DM insufficiently controlled by liraglutide alone. RESULTS: 59.4% (19/32) and 66.7% (22/33) of patients in the empagliflozin 10 mg and 25 mg groups, respectively, reported at least one adverse event (AE). 9.4% (3/32) and 21.2% (7/33) of patients, respectively, reported drug-related AEs (primary endpoint). From baseline to week 52, adjusted mean changes with empagliflozin 10 mg and 25 mg, respectively, were: - 0.55 (standard error: 0.15) and - 0.77 (0.14)% for glycated haemoglobin; - 32.5 (4.6) and - 36.0 (4.5) mg/dL for fasting plasma glucose; - 2.6 (0.4) and -3.1 (0.3) kg for body weight; - 6.7 (2.2) and - 8.4 (2.1) mmHg for systolic blood pressure; and - 3.0 (1.2) and - 4.7 (1.1) mmHg for diastolic blood pressure. CONCLUSION:
Empagliflozin as an add-on to liraglutide for 52 weeks was well tolerated and led to clinically meaningful and sustained improvements in glycaemic control, body weight and blood pressure in Japanese patients with T2DM. TRIAL REGISTRATION: ClinicalTrials.gov with the identifier NCT02589626. FUNDING: Nippon Boehringer Ingelheim Co. Ltd.
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Authors | Yasuo Terauchi, Kazunori Utsunomiya, Atsutaka Yasui, Tetsuo Seki, Gang Cheng, Kosuke Shiki, Jisoo Lee |
Journal | Diabetes therapy : research, treatment and education of diabetes and related disorders
(Diabetes Ther)
Vol. 10
Issue 3
Pg. 951-963
(Jun 2019)
ISSN: 1869-6953 [Print] United States |
PMID | 30912033
(Publication Type: Journal Article)
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