Long-term Safety and Efficacy of Empagliflozin as Add on to GLP-1 RA

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: empagliflozin 10mg; Drug: empagliflozin 25 mg; Drug: Placebo

• Registration Number: NCT02589626
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This is a multi-center, randomised, double-blind, parallel-group, safety and efficacy study of empagliflozin as add-on to GLP-1 RA 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 First Posted: 2015-10-28
• Study Start: 2015-10-29
• Primary Completion: 2017-06-02
• Study Completion: 2017-06-02
• Results First Submitted: 2018-05-31
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-04
• Last Update Submitted: 2019-01-04
• Results First Posted: 2019-01-07
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
empagliflozin 10 mg	empagliflozin 10mg	empagliflozin 10 mg tablet and placebo matching empagliflozin 25 mg tablet
empagliflozin 10 mg	Placebo	empagliflozin 10 mg tablet and placebo matching empagliflozin 25 mg tablet
empagliflozin 25 mg	empagliflozin 25 mg	empagliflozin 25 mg tablet and placebo matching empagliflozin 10 mg tablet
empagliflozin 25 mg	Placebo	empagliflozin 25 mg tablet and placebo matching empagliflozin 10 mg tablet

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment	52 weeks	Percentage of patients with drug-related Adverse events (AEs) during 52 weeks of treatment are presented

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c After 52 Weeks of Treatment	baseline and 52 weeks	Change from baseline in HbA1c after 52 weeks of treatment is presented. Means presented are the adjusted means.

Trial Locations

Locations (16)

Seino I.M. Clinic, Fukushima, I.M.; 🇯🇵 Fukushima, Koriyama, Japan

Kubota Clinic; 🇯🇵 Kanagawa, Kawasaki, Japan

Kunisaki Makoto Clinic; 🇯🇵 Fukuoka, Fukuoka, Japan

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

Nakakinen Clinic; 🇯🇵 Ibaraki, Naka, Japan

Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic; 🇯🇵 Kanagawa, Yamato-shi, Japan

Yokkaichi Diabetes Clinic; 🇯🇵 Mie, Yokkaichi, Japan

AMC Nishi-umeda Clinic; 🇯🇵 Osaka, Osaka-shi, Japan

Yokohama Minoru Clinic; 🇯🇵 Kanagawa, Yokohama, Japan

Shiraiwa Medical Clinic; 🇯🇵 Osaka, Kashiwara-shi, Japan

OCROM Clinic; 🇯🇵 Osaka, Suita, Japan

ToCROM Clinic; 🇯🇵 Tokyo, Shinjuku-ku, Japan

Fukuwa Clinic; 🇯🇵 Tokyo, Chuo-ku, Japan

Tokyo-Eki Center-building Clinic; 🇯🇵 Tokyo, Chuo-ku, Japan

Minamino Heart Clinic; 🇯🇵 Tokyo, Hachioji, Japan

Shinjuku Research Park Clinic; 🇯🇵 Tokyo, Shinjuku-ku, Japan