A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus Subjects
Phase 2
Completed
- Conditions
- Diabetes Mellitus Type 2
- Interventions
- Registration Number
- NCT00454233
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The purpose of this study is to investigate the safety of YM543 in type 2 Diabetes Mellitus patients and to investigate whether this study drug is effective in these patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
Inclusion Criteria
- Treatment-naive subjects diagnosed with T2DM
- Stable diet and exercise program for at least 6 weeks
- Inadequate glycemic control indicated by HbA1c and FPG level at Visit 1
Exclusion Criteria
- Any known complication of T2DM indicating a late disease state, clinical manifestations of macro- and/or micro vascular disorders
- Use of insulin or oral blood glucose lowering drugs in the last 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 YM543 Dose 2 3 YM543 Dose 3 4 YM543 Dose 4 5 Metformin - 6 Placebo - 1 YM543 Dose 1
- Primary Outcome Measures
Name Time Method Safety and tolerability (adverse events; biochemical, hematological and urine analysis tests; vital signs, 12-lead ECG, physical examination) 3 Months
- Secondary Outcome Measures
Name Time Method Efficacy and pharmacodynamics (change in HbA1c and fasting plasma glucose; change in urinary glucose excretion; plasma levels of YM543; C-peptide, insulin, fructosamine, non-esterified fatty acids, triglyceride, cholesterol-panel) 3 Months
Trial Locations
- Locations (2)
4 Sites
🇷🇺Moscow, Russian Federation
10 Sites
🇷🇺St. Petersburg, Russian Federation