A Study of RO5093151 and RO5027838 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin
NCT ID: NCT00823680
Last Updated: 2016-07-28
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
110 participants
INTERVENTIONAL
2009-04-30
2009-08-31
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
DOUBLE
Study Groups
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Placebo
Placebo
po bid for 4 weeks
RO5027838 200mg
RO5027838
200mg po qd for 4 weeks
RO5027838 50mg
RO5027838
50mg po bid for 4 weeks
RO5093151 10mg
RO5093151
10mg po bid for 4 weeks
RO5093151 400mg
RO5093151
400mg po bid for 4 weeks
Interventions
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Placebo
po bid for 4 weeks
RO5027838
200mg po qd for 4 weeks
RO5027838
50mg po bid for 4 weeks
RO5093151
400mg po bid for 4 weeks
RO5093151
10mg po bid for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* type 2 diabetes for \>=3 months;
* treated for \>=3 months with stable dose of metformin \>=1.5g/day or maximum tolerated dose.
Exclusion Criteria
* currently or previously treated with insulin;
* currently or within previous 6 months treated with a thiazolidinedione or dual peroxisome proliferator activated receptor (PPAR) agonist;
* treated with lipoprotein-modifying therapy within a month before screening.
35 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Chula Vista, California, United States
Miami, Florida, United States
Graz, , Austria
München, , Germany
Neuss, , Germany
Countries
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Other Identifiers
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2008-001122-13
Identifier Type: -
Identifier Source: secondary_id
BP21850
Identifier Type: -
Identifier Source: org_study_id
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