Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Empagliflozin; Drug: Placebo

• Registration Number: NCT02589639
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group, efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-27
• Study Start: 2015-10-28
• Study First Posted: 2015-10-28
• Primary Completion: 2017-04-18
• Study Completion: 2018-01-05
• Status Verified: 2018-12
• Results First Submitted: 2018-12-11
• Results First Submitted QC: 2018-12-11
• Last Update Submitted: 2018-12-11
• Results First Posted: 2019-03-27
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
empagliflozin 10 mg	Empagliflozin	-
empagliflozin 10 mg	Placebo	-
empagliflozin 25 mg	Empagliflozin	-
empagliflozin 25 mg	Placebo	-
placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment.	Baseline and 16 weeks	The primary endpoint was the change from baseline in HbA1c after 16 weeks of treatment.; The term "baseline" refers to the last observation prior to the administration of any randomised study drug.; Means presented are the adjusted means.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Investigator Defined Drug-Related Adverse Events (AEs)	From 1st intake of study drug to last intake of study drug + 7 days; up to 53 weeks	Percentage of patients with investigator defined drug-related Adverse Events (AEs) are presented

Trial Locations

Locations (48)

Nakayama Clinic; 🇯🇵 Aichi, Japan

Kashiwa City Hospital; 🇯🇵 Chiba, Kashiwa, Japan

Saiseikai Fukuoka General Hospital; 🇯🇵 Fukuoka, Fukuoka, Japan

Seiwakai Medical Corporation Nagata Hospital; 🇯🇵 Fukuoka, Yanagawa, Japan

Kunisaki Makoto Clinic; 🇯🇵 Fukuoka, Japan

Saiseikai Maebashi Hospital; 🇯🇵 Gunma, Maebashi, Japan

Nippon Kokan Fukuyama Hospital; 🇯🇵 Hiroshima, Fukuyama, Japan

Jiyugaoka Yokoyama Naika Clinic; 🇯🇵 Hokkaido, Obihiro, Japan

Jiyugaoka Yamada Clinic; 🇯🇵 Hokkaido, Obihiro, Japan

Souen Diabetes Clinic; 🇯🇵 Hokkaido, Sapporo, Japan

Scroll for more (38 remaining)