Overview
Japanese Phase 1 Multiple Ascending Dose Study
Status:
Completed
Completed
Trial end date:
2012-09-01
2012-09-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Bristol-Myers Squibb
Criteria
Inclusion Criteria:- 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 Criteria:
- 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