MedPath

Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Placebo (low dose)
Drug: Placebo (high dose)
Registration Number
NCT01368081
Lead Sponsor
Boehringer Ingelheim
Brief Summary

The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1162
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BI 10773 low doseBI 10773BI 10773 low dose tablet once daily
BI 10773 low dosePlacebo (high dose)BI 10773 low dose tablet once daily
BI 10773 high dosePlacebo (low dose)BI 10773 high dose tablet once daily
BI 10773 high doseBI 10773BI 10773 high dose tablet once daily
MetforminMetforminMetformin tablets 500-2250 mg a day (twice or three times per day)
Primary Outcome Measures
NameTimeMethod
Number of Patients With Drug Related Adverse EventsAfter the first drug intake until 7 days after the last treatment administration, up to 383 days

Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days

Secondary Outcome Measures
NameTimeMethod
Change From Baseline in HbA1cBaseline and 52 weeks

Change from baseline in HbA1c after 52 weeks of treatment

Trial Locations

Locations (87)

1245.52.023 Boehringer Ingelheim Investigational Site

🇯🇵

Adachi-ku, Tokyo, Japan

1245.52.048 Boehringer Ingelheim Investigational Site

🇯🇵

Aki-gun, Hiroshima, Japan

1245.52.012 Boehringer Ingelheim Investigational Site

🇯🇵

Annaka, Gunma, Japan

1245.52.087 Boehringer Ingelheim Investigational Site

🇯🇵

Atami, Shizuoka, Japan

1245.52.008 Boehringer Ingelheim Investigational Site

🇯🇵

Beppu, Oita, Japan

1245.52.073 Boehringer Ingelheim Investigational Site

🇯🇵

Chiyoda-ku, Tokyo, Japan

1245.52.002 Boehringer Ingelheim Investigational Site

🇯🇵

Chuo-ku, Tokyo, Japan

1245.52.020 Boehringer Ingelheim Investigational Site

🇯🇵

Chuo-ku, Tokyo, Japan

1245.52.021 Boehringer Ingelheim Investigational Site

🇯🇵

Chuo-ku, Tokyo, Japan

1245.52.031 Boehringer Ingelheim Investigational Site

🇯🇵

Fujisawa, Kanagawa, Japan

Scroll for more (77 remaining)
1245.52.023 Boehringer Ingelheim Investigational Site
🇯🇵Adachi-ku, Tokyo, Japan

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.