Japanese Phase 1 MAD study
Phase 1
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- JPRN-jRCT2080221729
- Lead Sponsor
- Bristol-Myers K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
for T2DM patients:
- Japanese patients with Type 2 Diabetes Mellitus (Fasting glucose < 240 mg/dL, HbA1c: 6.5% to 10.0% (NGSP)) who are treatment-naive and managed with diet and/or exercises only.
Exclusion Criteria
for T2DM patients:
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method