- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01193218
Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus
May 16, 2014 updated by: Boehringer Ingelheim
A Double-blind, Randomised, Parallel Group Efficacy and Safety Study of BI 10773 (5 mg, 10 mg, 25 mg, and 50 mg) Compared to Placebo When Administered Orally Once Daily Over 12 Weeks, as Monotherapy, in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Diet and Exercise, Followed by a 40 Week Randomised Extension Study to Assess Long Term Safety of BI 10773 (10 mg and 25 mg)
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
547
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chiyoda-ku, Tokyo, Japan
- 1245.38.016 Boehringer Ingelheim Investigational Site
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Chuo-ku, Tokyo, Japan
- 1245.38.001 Boehringer Ingelheim Investigational Site
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Chuo-ku, Tokyo, Japan
- 1245.38.003 Boehringer Ingelheim Investigational Site
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Hachioji, Tokyo, Japan
- 1245.38.002 Boehringer Ingelheim Investigational Site
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Hanamaki, Iwate, Japan
- 1245.38.010 Boehringer Ingelheim Investigational Site
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Kamakura, Kanagawa, Japan
- 1245.38.005 Boehringer Ingelheim Investigational Site
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Kanazawa, Ishikawa, Japan
- 1245.38.020 Boehringer Ingelheim Investigational Site
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Kashiwa, Chiba, Japan
- 1245.38.013 Boehringer Ingelheim Investigational Site
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Katsushika-ku, Tokyo, Japan
- 1245.38.019 Boehringer Ingelheim Investigational Site
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Kyoto, Kyoto, Japan
- 1245.38.021 Boehringer Ingelheim Investigational Site
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Matsuyama, Ehime, Japan
- 1245.38.024 Boehringer Ingelheim Investigational Site
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Minato-ku, Tokyo, Japan
- 1245.38.004 Boehringer Ingelheim Investigational Site
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Moriya, Ibaraki, Japan
- 1245.38.011 Boehringer Ingelheim Investigational Site
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Naha, Okinawa, Japan
- 1245.38.030 Boehringer Ingelheim Investigational Site
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Okawa, Fukuoka, Japan
- 1245.38.032 Boehringer Ingelheim Investigational Site
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Okinawa, Okinawa, Japan
- 1245.38.031 Boehringer Ingelheim Investigational Site
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Saga, Saga, Japan
- 1245.38.025 Boehringer Ingelheim Investigational Site
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Saitama, Saitama, Japan
- 1245.38.014 Boehringer Ingelheim Investigational Site
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Sapporo, Hokkaido, Japan
- 1245.38.006 Boehringer Ingelheim Investigational Site
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Sapporo, Hokkaido, Japan
- 1245.38.007 Boehringer Ingelheim Investigational Site
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Sapporo, Hokkaido, Japan
- 1245.38.008 Boehringer Ingelheim Investigational Site
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Sapporo, Hokkaido, Japan
- 1245.38.009 Boehringer Ingelheim Investigational Site
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Sasima-gun, Ibaraki, Japan
- 1245.38.012 Boehringer Ingelheim Investigational Site
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Shinjuku-ku, Tokyo, Japan
- 1245.38.015 Boehringer Ingelheim Investigational Site
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Shinjuku-ku, Tokyo, Japan
- 1245.38.018 Boehringer Ingelheim Investigational Site
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Suginami-ku, Tokyo, Japan
- 1245.38.017 Boehringer Ingelheim Investigational Site
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Suita, Osaka, Japan
- 1245.38.022 Boehringer Ingelheim Investigational Site
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Ube, Yamaguchi, Japan
- 1245.38.023 Boehringer Ingelheim Investigational Site
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Urasoe, Okinawa, Japan
- 1245.38.026 Boehringer Ingelheim Investigational Site
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Urasoe, Okinawa, Japan
- 1245.38.027 Boehringer Ingelheim Investigational Site
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Urasoe, Okinawa, Japan
- 1245.38.028 Boehringer Ingelheim Investigational Site
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Urasoe, Okinawa, Japan
- 1245.38.029 Boehringer Ingelheim Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Diagnosis of type 2 diabetes mellitus prior to informed consent
Male and female patients on diet and exercise regimen who are:
- drug-naïve, defined as no antidiabetic drugs for 10 weeks prior to informed consent.
- pre-treated with one oral antidiabetic drug; the present antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent.
HbA1c at Visit 1a:
- for patients who are drug naïve: HbA1c >=7.0 to =<10.0%
- for patients treated with one oral antidiabetic drug: HbA1c >=6.5 to =<9.0%
- HbA1c of >=7.0% and =<10% at Visit 2 (start of run-in)
Exclusion criteria:
- Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L) after an overnight fast during wash-out/placebo run-in period and confirmed by a second measurement (not on the same day).
- Acute coronary syndromes, stroke or transient ischaemic attack within 12 weeks prior to informed consent
- Impaired renal function, defined as calculated eGFR <60 ml/min (MDRD formula) during screening and/or wash-out period and/or run-in phase.
- Bariatric surgery within the past 2 years and other gastrointestinal surgeries that induce chronic malabsorption
- Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
- Treatment with anti-obesity drugs (e.g. sibutramine, mazindol) 12 weeks prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BI 10773 low dose QD
BI 10773 tablets low dose once a day
|
Placebo tablets once a day
Placebo tablets once a day
BI 10773 tablets low dose once a day
BI 10773 tablets mid-high dose once a day
BI 10773 tablets high dose once a day
BI 10773 tablets mid-low dose once a day
|
Experimental: BI 10773 mid-low dose QD
BI 10773 tablets mid-low dose once a day
|
Placebo tablets once a day
Placebo tablets once a day
BI 10773 tablets low dose once a day
BI 10773 tablets mid-high dose once a day
BI 10773 tablets high dose once a day
BI 10773 tablets mid-low dose once a day
|
Experimental: BI 10773 mid-high dose QD
BI 10773 tablets mid-high dose once a day
|
Placebo tablets once a day
Placebo tablets once a day
Placebo tablets once a day
BI 10773 tablets low dose once a day
BI 10773 tablets mid-high dose once a day
BI 10773 tablets high dose once a day
BI 10773 tablets mid-low dose once a day
|
Experimental: BI 10773 high dose QD
BI 10773 tablets high dose once a day
|
Placebo tablets once a day
Placebo tablets once a day
BI 10773 tablets low dose once a day
BI 10773 tablets mid-high dose once a day
BI 10773 tablets high dose once a day
BI 10773 tablets mid-low dose once a day
|
Placebo Comparator: Placebo
Placebo tablets once a day
|
Placebo tablets once a day
Placebo tablets once a day
Placebo tablets once a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in HbA1c After 12 Weeks of Treatment.
Time Frame: baseline and 12 weeks
|
The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.
|
baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of Treat to Target Efficacy Response
Time Frame: baseline and 12 weeks
|
Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after 12 weeks of treatment
|
baseline and 12 weeks
|
Change From Baseline in FPG
Time Frame: baseline and 12 weeks
|
Change from baseline in FPG after 12 weeks of treatment
|
baseline and 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confirmed Hypoglycaemic Adverse Events
Time Frame: between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
Number of patients with confirmed hypoglycaemic adverse events
|
between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
- Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.
- Kadowaki T, Haneda M, Inagaki N, Terauchi Y, Taniguchi A, Koiwai K, Rattunde H, Woerle HJ, Broedl UC. Efficacy and safety of empagliflozin monotherapy for 52 weeks in Japanese patients with type 2 diabetes: a randomized, double-blind, parallel-group study. Adv Ther. 2015 Apr;32(4):306-18. doi: 10.1007/s12325-015-0198-0. Epub 2015 Apr 7.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
August 31, 2010
First Submitted That Met QC Criteria
August 31, 2010
First Posted (Estimate)
September 1, 2010
Study Record Updates
Last Update Posted (Estimate)
June 17, 2014
Last Update Submitted That Met QC Criteria
May 16, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1245.38
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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