A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT00961909
Last Updated: 2016-11-02
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
PHASE1
122 participants
INTERVENTIONAL
2009-06-30
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
DOUBLE
Study Groups
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1active
RO5095932
cohorts receiving multiple ascending doses, sc once weekly for 4 weeks
metformin
stable dose
1placebo
metformin
stable dose
placebo
sc once weekly for 4 weeks
2active
RO5095932
dose titration to target dose, sc once weekly for 6 weeks
metformin
stable dose
2placebo
metformin
stable dose
placebo
sc once weekly for 4 weeks
Interventions
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RO5095932
cohorts receiving multiple ascending doses, sc once weekly for 4 weeks
RO5095932
dose titration to target dose, sc once weekly for 6 weeks
metformin
stable dose
placebo
sc once weekly for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* females who are either surgically sterile or post-menopausal
* type 2 diabetes treated with a stable dose of metformin
* BMI between 25-39kg/m2
* HbA1c between 7 and 10%
* fasting plasma glucose between 7 and 13.3mmol/L
Exclusion Criteria
* history of clinically significant hepatic or renal disease or impairment
* recent therapy with insulin, thiazolidinedione, glucagon-like peptide-1 analogues, amylin analogues and/or DPP-IV inhibitors
18 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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Anaheim, California, United States
Chula Vista, California, United States
Fort Myers, Florida, United States
Miramar, Florida, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Countries
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Other Identifiers
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NP22340
Identifier Type: -
Identifier Source: org_study_id