Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: BI 10773; Drug: Placebo (mid dose); Drug: Placebo (high dose); Drug: Placebo (low dose)

• Registration Number: NCT01193218
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period. The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-31
• Study First Submitted QC: 2010-08-31
• Study Start: 2010-09
• Study First Posted: 2010-09-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• 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: 547

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
BI 10773 mid-high dose QD	BI 10773	BI 10773 tablets mid-high dose once a day
BI 10773 low dose QD	Placebo (mid dose)	BI 10773 tablets low dose once a day
BI 10773 low dose QD	Placebo (high dose)	BI 10773 tablets low dose once a day
BI 10773 low dose QD	BI 10773	BI 10773 tablets low dose once a day
BI 10773 mid-low dose QD	Placebo (high dose)	BI 10773 tablets mid-low dose once a day
BI 10773 mid-high dose QD	Placebo (high dose)	BI 10773 tablets mid-high dose once a day
BI 10773 mid-low dose QD	BI 10773	BI 10773 tablets mid-low dose once a day
BI 10773 mid-low dose QD	Placebo (low dose)	BI 10773 tablets mid-low dose once a day
BI 10773 mid-high dose QD	Placebo (low dose)	BI 10773 tablets mid-high dose once a day
Placebo	Placebo (mid dose)	Placebo tablets once a day
BI 10773 mid-high dose QD	Placebo (mid dose)	BI 10773 tablets mid-high dose once a day
BI 10773 high dose QD	Placebo (low dose)	BI 10773 tablets high dose once a day
BI 10773 high dose QD	Placebo (mid dose)	BI 10773 tablets high dose once a day
Placebo	Placebo (low dose)	Placebo tablets once a day
Placebo	Placebo (high dose)	Placebo tablets once a day
BI 10773 high dose QD	BI 10773	BI 10773 tablets high dose once a day

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c After 12 Weeks of Treatment.	baseline and 12 weeks	The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Occurrence of Treat to Target Efficacy Response	baseline and 12 weeks	Occurrence of treat to target efficacy response, that is an HbA1c of \<7.0% after 12 weeks of treatment
Change From Baseline in FPG	baseline and 12 weeks	Change from baseline in FPG after 12 weeks of treatment

Trial Locations

Locations (32)

1245.38.003 Boehringer Ingelheim Investigational Site; 🇯🇵 Chuo-ku, Tokyo, Japan

1245.38.032 Boehringer Ingelheim Investigational Site; 🇯🇵 Okawa, Fukuoka, Japan

1245.38.012 Boehringer Ingelheim Investigational Site; 🇯🇵 Sasima-gun, Ibaraki, Japan

1245.38.031 Boehringer Ingelheim Investigational Site; 🇯🇵 Okinawa, Okinawa, Japan

1245.38.022 Boehringer Ingelheim Investigational Site; 🇯🇵 Suita, Osaka, Japan

1245.38.020 Boehringer Ingelheim Investigational Site; 🇯🇵 Kanazawa, Ishikawa, Japan

1245.38.002 Boehringer Ingelheim Investigational Site; 🇯🇵 Hachioji, Tokyo, Japan

1245.38.030 Boehringer Ingelheim Investigational Site; 🇯🇵 Naha, Okinawa, Japan

1245.38.021 Boehringer Ingelheim Investigational Site; 🇯🇵 Kyoto, Kyoto, Japan

1245.38.010 Boehringer Ingelheim Investigational Site; 🇯🇵 Hanamaki, Iwate, Japan

1245.38.006 Boehringer Ingelheim Investigational Site; 🇯🇵 Sapporo, Hokkaido, Japan

1245.38.007 Boehringer Ingelheim Investigational Site; 🇯🇵 Sapporo, Hokkaido, Japan

1245.38.005 Boehringer Ingelheim Investigational Site; 🇯🇵 Kamakura, Kanagawa, Japan

1245.38.013 Boehringer Ingelheim Investigational Site; 🇯🇵 Kashiwa, Chiba, Japan

1245.38.008 Boehringer Ingelheim Investigational Site; 🇯🇵 Sapporo, Hokkaido, Japan

1245.38.001 Boehringer Ingelheim Investigational Site; 🇯🇵 Chuo-ku, Tokyo, Japan

1245.38.028 Boehringer Ingelheim Investigational Site; 🇯🇵 Urasoe, Okinawa, Japan

1245.38.016 Boehringer Ingelheim Investigational Site; 🇯🇵 Chiyoda-ku, Tokyo, Japan

1245.38.011 Boehringer Ingelheim Investigational Site; 🇯🇵 Moriya, Ibaraki, Japan

1245.38.025 Boehringer Ingelheim Investigational Site; 🇯🇵 Saga, Saga, Japan

1245.38.014 Boehringer Ingelheim Investigational Site; 🇯🇵 Saitama, Saitama, Japan

1245.38.019 Boehringer Ingelheim Investigational Site; 🇯🇵 Katsushika-ku, Tokyo, Japan

1245.38.024 Boehringer Ingelheim Investigational Site; 🇯🇵 Matsuyama, Ehime, Japan

1245.38.015 Boehringer Ingelheim Investigational Site; 🇯🇵 Shinjuku-ku, Tokyo, Japan

1245.38.004 Boehringer Ingelheim Investigational Site; 🇯🇵 Minato-ku, Tokyo, Japan

1245.38.009 Boehringer Ingelheim Investigational Site; 🇯🇵 Sapporo, Hokkaido, Japan

1245.38.017 Boehringer Ingelheim Investigational Site; 🇯🇵 Suginami-ku, Tokyo, Japan

1245.38.018 Boehringer Ingelheim Investigational Site; 🇯🇵 Shinjuku-ku, Tokyo, Japan

1245.38.026 Boehringer Ingelheim Investigational Site; 🇯🇵 Urasoe, Okinawa, Japan

1245.38.023 Boehringer Ingelheim Investigational Site; 🇯🇵 Ube, Yamaguchi, Japan

1245.38.027 Boehringer Ingelheim Investigational Site; 🇯🇵 Urasoe, Okinawa, Japan

1245.38.029 Boehringer Ingelheim Investigational Site; 🇯🇵 Urasoe, Okinawa, Japan