Status:
COMPLETED
Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Boehringer Ingelheim
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
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 suff...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
547 Patients enrolled
Trial Details
Trial ID
NCT01193218
Start Date
September 1 2010
End Date
June 1 2012
Last Update
June 17 2014
Active Locations (32)
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1
1245.38.016 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo, Japan
2
1245.38.001 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
3
1245.38.003 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
4
1245.38.002 Boehringer Ingelheim Investigational Site
Hachioji, Tokyo, Japan