Status:
COMPLETED
Japanese Phase 1 Multiple Ascending Dose Study
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20-65 years
Phase:
PHASE1
Brief Summary
The purpose of this clinical study is to assess the safety and tolerability of multiple oral doses of BMS-823778 in healthy Japanese subjects and Japanese patients with Type 2 Diabetes Mellitus.
Detailed Description
MAD study - Multiple Ascending Dose study
Eligibility Criteria
Inclusion
- Japanese patients with Type 2 Diabetes Mellitus (T2DM) \[Fasting glucose \< 240 mg/dL, Hemoglobin A1c (HbA1c): 6.5% to 10.0% National Glycohemoglobin Standardization Program (NGSP)\] who are treatment-naive and managed with diet and/or exercises only, ages: 20 to 65 years
Exclusion
- Patient who is taking any medication for T2DM
- Symptoms of poorly controlled diabetes that would preclude participation in this placebo-controlled trial
- Insulin therapy within one year of screening
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01515202
Start Date
March 1 2012
End Date
September 1 2012
Last Update
December 5 2012
Active Locations (1)
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1
Local Institution
Hachioji-Shi, Tokyo, Japan, 1920071