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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Page 1 of 2 (6 locations)

1

4 Sites

Moscow, Russia

2

Nizhny Novgorod, Russia

3

Petrozavodsk, Russia

4

10 Sites

Saint Petersburg, Russia