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: BI 10773; Drug: Placebo (low dose); Drug: Metformin; 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

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-19
• Study First Submitted QC: 2011-06-06
• Study First Posted: 2011-06-07
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2014-05
• Results First Submitted: 2014-05-16
• Results First Submitted QC: 2014-05-16
• Last Update Submitted: 2014-05-16
• Results First Posted: 2014-06-17
• Last Update Posted: 2014-06-17

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

Group	Intervention	Description
BI 10773 low dose	BI 10773	BI 10773 low dose tablet once daily
BI 10773 low dose	Placebo (high dose)	BI 10773 low dose tablet once daily
BI 10773 high dose	Placebo (low dose)	BI 10773 high dose tablet once daily
BI 10773 high dose	BI 10773	BI 10773 high dose tablet once daily
Metformin	Metformin	Metformin tablets 500-2250 mg a day (twice or three times per day)

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Change From Baseline in HbA1c	Baseline 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

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