A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus Subjects
NCT ID: NCT00454233
Last Updated: 2008-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
97 participants
INTERVENTIONAL
2007-02-28
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Dose 1
YM543
Oral
2
Dose 2
YM543
Oral
3
Dose 3
YM543
Oral
4
Dose 4
YM543
Oral
5
Metformin
Oral
6
Placebo
oral
Interventions
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YM543
Oral
Metformin
Oral
Placebo
oral
Eligibility Criteria
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Inclusion Criteria
* Stable diet and exercise program for at least 6 weeks
* Inadequate glycemic control indicated by HbA1c and FPG level at Visit 1
Exclusion Criteria
* Use of insulin or oral blood glucose lowering drugs in the last 3 months
18 Years
65 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Astellas Pharma Europe BV
Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Europe B.V.
Locations
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4 Sites
Moscow, , Russia
Nizhny Novgorod, , Russia
Petrozavodsk, , Russia
10 Sites
Saint Petersburg, , Russia
Samara, , Russia
Yekaterinburg, , Russia
Countries
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Other Identifiers
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EudraCT number: 2006-001110-33
Identifier Type: -
Identifier Source: secondary_id
543-CL-003
Identifier Type: -
Identifier Source: org_study_id
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