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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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

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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 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)

1245.52.033 Boehringer Ingelheim Investigational Site; 🇯🇵 Isehara, Kanagawa, Japan

1245.52.052 Boehringer Ingelheim Investigational Site; 🇯🇵 Kitakyushu, Fukuoka, Japan

1245.52.073 Boehringer Ingelheim Investigational Site; 🇯🇵 Chiyoda-ku, Tokyo, Japan

1245.52.002 Boehringer Ingelheim Investigational Site; 🇯🇵 Chuo-ku, Tokyo, Japan

1245.52.069 Boehringer Ingelheim Investigational Site; 🇯🇵 Koriyama, Fukushima, Japan

1245.52.080 Boehringer Ingelheim Investigational Site; 🇯🇵 Maebashi, Gunma, Japan

1245.52.079 Boehringer Ingelheim Investigational Site; 🇯🇵 Morioka, Iwate, Japan

1245.52.046 Boehringer Ingelheim Investigational Site; 🇯🇵 Himeji, Hyogo, Japan

1245.52.088 Boehringer Ingelheim Investigational Site; 🇯🇵 Kamakura, Kanagawa, Japan

1245.52.019 Boehringer Ingelheim Investigational Site; 🇯🇵 Kashiwa, Chiba, Japan

1245.52.022 Boehringer Ingelheim Investigational Site; 🇯🇵 Kita-ku, Tokyo, Japan

1245.52.026 Boehringer Ingelheim Investigational Site; 🇯🇵 Kodaira, Tokyo, Japan

1245.52.071 Boehringer Ingelheim Investigational Site; 🇯🇵 Koriyama, Fukushima, Japan

1245.52.014 Boehringer Ingelheim Investigational Site; 🇯🇵 Koshigaya, Saitama, Japan

1245.52.005 Boehringer Ingelheim Investigational Site; 🇯🇵 Nagoya, Aichi, Japan

1245.52.038 Boehringer Ingelheim Investigational Site; 🇯🇵 Nagoya, Aichi, Japan

1245.52.059 Boehringer Ingelheim Investigational Site; 🇯🇵 Naha, Okinawa, Japan

1245.52.066 Boehringer Ingelheim Investigational Site; 🇯🇵 Naha, Okinawa, Japan

1245.52.068 Boehringer Ingelheim Investigational Site; 🇯🇵 Okinawa, Okinawa, Japan

1245.52.042 Boehringer Ingelheim Investigational Site; 🇯🇵 Osaka,Osaka, Japan

1245.52.024 Boehringer Ingelheim Investigational Site; 🇯🇵 Ota-ku, Tokyo, Japan

1245.52.044 Boehringer Ingelheim Investigational Site; 🇯🇵 Sakai, Osaka, Japan

1245.52.081 Boehringer Ingelheim Investigational Site; 🇯🇵 Yokohama, Kanagawa, Japan

1245.52.023 Boehringer Ingelheim Investigational Site; 🇯🇵 Adachi-ku, Tokyo, Japan

1245.52.087 Boehringer Ingelheim Investigational Site; 🇯🇵 Atami, Shizuoka, Japan

1245.52.020 Boehringer Ingelheim Investigational Site; 🇯🇵 Chuo-ku, Tokyo, Japan

1245.52.037 Boehringer Ingelheim Investigational Site; 🇯🇵 Hamamatsu, Shizuoka, Japan

1245.52.047 Boehringer Ingelheim Investigational Site; 🇯🇵 Hiroshima, Hiroshima, Japan

1245.52.016 Boehringer Ingelheim Investigational Site; 🇯🇵 Iruma,Saitama, Japan

1245.52.011 Boehringer Ingelheim Investigational Site; 🇯🇵 Isesaki, Gunma, Japan

1245.52.072 Boehringer Ingelheim Investigational Site; 🇯🇵 Kamakura,Kanagawa, Japan

1245.52.039 Boehringer Ingelheim Investigational Site; 🇯🇵 Kasugai, Aichi, Japan

1245.52.018 Boehringer Ingelheim Investigational Site; 🇯🇵 Kita-adachi-gun, Saitama, Japan

1245.52.027 Boehringer Ingelheim Investigational Site; 🇯🇵 Kawasaki, Kanagawa, Japan

1245.52.040 Boehringer Ingelheim Investigational Site; 🇯🇵 Kyoto, Kyoto, Japan

1245.52.010 Boehringer Ingelheim Investigational Site; 🇯🇵 Maebashi, Gunma, Japan

1245.52.050 Boehringer Ingelheim Investigational Site; 🇯🇵 Matsuyama, Ehime, Japan

1245.52.003 Boehringer Ingelheim Investigational Site; 🇯🇵 Nagoya, Aichi, Japan

1245.52.004 Boehringer Ingelheim Investigational Site; 🇯🇵 Nagoya, Aichi, Japan

1245.52.065 Boehringer Ingelheim Investigational Site; 🇯🇵 Nanjyo, Okinawa, Japan

1245.52.089 Boehringer Ingelheim Investigational Site; 🇯🇵 Osaki, Miyagi, Japan

1245.52.032 Boehringer Ingelheim Investigational Site; 🇯🇵 Sagamihara, Kanagawa, Japan

1245.52.054 Boehringer Ingelheim Investigational Site; 🇯🇵 Saga, Saga, Japan

1245.52.085 Boehringer Ingelheim Investigational Site; 🇯🇵 Sagamihara, Kanagawa, Japan

1245.52.015 Boehringer Ingelheim Investigational Site; 🇯🇵 Sakado, Saitama, Japan

1245.52.013 Boehringer Ingelheim Investigational Site; 🇯🇵 Saitama, Saitama, Japan

1245.52.035 Boehringer Ingelheim Investigational Site; 🇯🇵 Saku, Nagano, Japan

1245.52.009 Boehringer Ingelheim Investigational Site; 🇯🇵 Sapporo, Hokkaido, Japan

1245.52.025 Boehringer Ingelheim Investigational Site; 🇯🇵 Setagaya-ku, Tokyo, Japan

1245.52.063 Boehringer Ingelheim Investigational Site; 🇯🇵 Shimajiri-gun, Okinawa, Japan

1245.52.036 Boehringer Ingelheim Investigational Site; 🇯🇵 Shizuoka, Shizuoka, Japan

1245.52.001 Boehringer Ingelheim Investigational Site; 🇯🇵 Shinjuku-ku. Tokyo, Japan

1245.52.064 Boehringer Ingelheim Investigational Site; 🇯🇵 Shimajiri-gun, Okinawa, Japan

1245.52.006 Boehringer Ingelheim Investigational Site; 🇯🇵 Suita, Osaka, Japan

1245.52.043 Boehringer Ingelheim Investigational Site; 🇯🇵 Takatsuki, Osaka, Japan

1245.52.017 Boehringer Ingelheim Investigational Site; 🇯🇵 Tokorozawa, Saitama, Japan

1245.52.061 Boehringer Ingelheim Investigational Site; 🇯🇵 Tomigusuku, Okinawa, Japan

1245.52.062 Boehringer Ingelheim Investigational Site; 🇯🇵 Tomigusuku, Okinawa, Japan

1245.52.070 Boehringer Ingelheim Investigational Site; 🇯🇵 Tokorozawa, Saitama, Japan

1245.52.041 Boehringer Ingelheim Investigational Site; 🇯🇵 Uji, Kyoto, Japan

1245.52.067 Boehringer Ingelheim Investigational Site; 🇯🇵 Uruma, Okinawa, Japan

1245.52.028 Boehringer Ingelheim Investigational Site; 🇯🇵 Yokohama, Kanagawa, Japan

1245.52.029 Boehringer Ingelheim Investigational Site; 🇯🇵 Yokohama, Kanagawa, Japan

1245.52.030 Boehringer Ingelheim Investigational Site; 🇯🇵 Yokohama, Kanagawa, Japan

1245.52.082 Boehringer Ingelheim Investigational Site; 🇯🇵 Yokohama, Kanagawa, Japan

1245.52.008 Boehringer Ingelheim Investigational Site; 🇯🇵 Beppu, Oita, Japan

1245.52.012 Boehringer Ingelheim Investigational Site; 🇯🇵 Annaka, Gunma, Japan

1245.52.021 Boehringer Ingelheim Investigational Site; 🇯🇵 Chuo-ku, Tokyo, Japan

1245.52.034 Boehringer Ingelheim Investigational Site; 🇯🇵 Kanazawa, Ishikawa, Japan

1245.52.057 Boehringer Ingelheim Investigational Site; 🇯🇵 Miyazaki, Miyazaki, Japan

1245.52.007 Boehringer Ingelheim Investigational Site; 🇯🇵 Oita, Oita, Japan

1245.52.084 Boehringer Ingelheim Investigational Site; 🇯🇵 Yokohama, Kanagawa, Japan

1245.52.031 Boehringer Ingelheim Investigational Site; 🇯🇵 Fujisawa, Kanagawa, Japan

1245.52.077 Boehringer Ingelheim Investigational Site; 🇯🇵 Fukuoka, Fukuoka, Japan

1245.52.086 Boehringer Ingelheim Investigational Site; 🇯🇵 Hadano, Kanagawa, Japan

1245.52.058 Boehringer Ingelheim Investigational Site; 🇯🇵 Kanoya, Kagoshima, Japan

1245.52.076 Boehringer Ingelheim Investigational Site; 🇯🇵 Kobe, Hyogo, Japan

1245.52.074 Boehringer Ingelheim Investigational Site; 🇯🇵 Kuki, Saitama, Japan

1245.52.055 Boehringer Ingelheim Investigational Site; 🇯🇵 Kumamoto, Kumamoto, Japan

1245.52.049 Boehringer Ingelheim Investigational Site; 🇯🇵 Kure, Hiroshima, Japan

1245.52.075 Boehringer Ingelheim Investigational Site; 🇯🇵 Meguro-ku, Tokyo, Japan

1245.52.048 Boehringer Ingelheim Investigational Site; 🇯🇵 Aki-gun, Hiroshima, Japan

1245.52.051 Boehringer Ingelheim Investigational Site; 🇯🇵 Imabari, Ehime, Japan

1245.52.045 Boehringer Ingelheim Investigational Site; 🇯🇵 Izumisano,Osaka, Japan

1245.52.056 Boehringer Ingelheim Investigational Site; 🇯🇵 Miyazaki, Miyazaki, Japan

1245.52.053 Boehringer Ingelheim Investigational Site; 🇯🇵 Okawa, Fukuoka, Japan

1245.52.083 Boehringer Ingelheim Investigational Site; 🇯🇵 Yokohama, Kanagawa, Japan