Status:
COMPLETED
A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus Subjects
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00454233
Start Date
February 1 2007
End Date
June 1 2008
Last Update
October 16 2008
Active Locations (6)
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1
4 Sites
Moscow, Russia
2
Nizhny Novgorod, Russia
3
Petrozavodsk, Russia
4
10 Sites
Saint Petersburg, Russia