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
367 participants
INTERVENTIONAL
2013-08-31
2016-03-31
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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MT-1303-Low
MT-1303-Low Dose
MT-1303-Low
MT-1303-Middle
MT-1303-Middle Dose
MT-1303-Middle
MT-1303-High
MT-1303-High Dose
MT-1303-High
Interventions
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MT-1303-Low
MT-1303-Middle
MT-1303-High
Eligibility Criteria
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Inclusion Criteria
* Able to provide written informed consent and to comply with the requirements of the protocol
* For males and females of reproductive potential, two methods of contraception must be used throughout the study and for 12 weeks after cessation of study medication. At least one of the methods of contraception must be a barrier method.
Exclusion Criteria
* Newly diagnosed diabetes mellitus during MT-1303-E04
18 Years
60 Years
ALL
No
Sponsors
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Mitsubishi Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Ludwig Kappos, MD
Role: STUDY_DIRECTOR
University Hospital, Basel, Switzerland
Locations
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Research Site
City Name, , Belgium
Research Site
City Name, , Bulgaria
Research Site
City Name, , Canada
Research Site
City Name, , Croatia
Research Site
City Name, , Czechia
Research Site
City Name, , Finland
Research Site
City Name, , Germany
Research Site
City Name, , Hungary
Research Site
City Name, , Italy
Research Site
City Name, , Lithuania
Research Site
City Name, , Poland
Research Site
City Name, , Russia
Research Site
City Name, , Serbia
Research Site
City Name, , Spain
Research Site
City Name, , Turkey (Türkiye)
Research Site
City Name, , Ukraine
Research Site
City Name, , United Kingdom
Countries
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Other Identifiers
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MT-1303-E05
Identifier Type: -
Identifier Source: org_study_id
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