A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus
NCT ID: NCT00800176
Last Updated: 2020-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
394 participants
INTERVENTIONAL
2009-01-22
2009-10-28
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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RO4998452 2.5mg
During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
RO4998452
2.5mg po daily for 12 weeks
RO4998452 20mg
During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.
RO4998452
20mg po daily for 12 weeks
RO4998452 40mg
During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
RO4998452
40mg po daily for 12 weeks
RO4998452 5mg
During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.
RO4998452
5mg po daily for 12 weeks
Placebo
During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast.
During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.
Placebo
po daily for 12 weeks
RO4998452 10mg
During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.
RO4998452
10mg po daily for 12 weeks
Interventions
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Placebo
po daily for 12 weeks
RO4998452
2.5mg po daily for 12 weeks
RO4998452
5mg po daily for 12 weeks
RO4998452
10mg po daily for 12 weeks
RO4998452
20mg po daily for 12 weeks
RO4998452
40mg po daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* type 2 diabetes, diagnosed for \>=3 months;
* either treated with diet, exercise and stable metformin, or with diet and exercise alone.
Exclusion Criteria
* currently or within 2 months prior to screening treated with an oral or injectable anti-diabetic agent except stable doses of metformin;
* currently or within 6 months prior to screening treated with any PPARgamma agonist;
* uncontrolled hypertension;
* significant pre-diagnosed diabetic complications requiring treatment.
18 Years
75 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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Phoenix, Arizona, United States
Los Angeles, California, United States
Palm Springs, California, United States
Bradenton, Florida, United States
Jacksonville, Florida, United States
Atlanta, Georgia, United States
Hayden Lake, Idaho, United States
Rochester, New York, United States
Greensboro, North Carolina, United States
Midland, Texas, United States
Richmond, Virginia, United States
Adelaide, , Australia
St Leonards, , Australia
Fortaleza, , Brazil
Goiânia, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Vancouver, British Columbia, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Berlin, , Germany
Falkensee, , Germany
Lübeck, , Germany
Mainz, , Germany
Neuss, , Germany
Hong Kong, , Hong Kong
Hong Kong, , Hong Kong
Fukuoka, , Japan
Ibaraki, , Japan
Kanagawa, , Japan
Osaka, , Japan
Saitama, , Japan
Saitama, , Japan
Tokyo, , Japan
Tokyo, , Japan
Jelgava, , Latvia
Riga, , Latvia
Talsi, , Latvia
Valmiera, , Latvia
Chihuahua City, , Mexico
Guadalajara, , Mexico
Guadalajara, , Mexico
Mexico City, , Mexico
Alba Iulia, , Romania
Brasov, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Târgu Mureş, , Romania
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
S.petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Yaroslavl, , Russia
Alzira, , Spain
Lleida, , Spain
Seville, , Spain
Countries
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Other Identifiers
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2008-001249-24
Identifier Type: -
Identifier Source: secondary_id
BC21587
Identifier Type: -
Identifier Source: org_study_id