A Study of Aleglitazar in Patients With Type 2 Diabetes
NCT ID: NCT00388518
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
PHASE2
332 participants
INTERVENTIONAL
2006-11-30
2008-03-31
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
DOUBLE
Study Groups
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Actos
Actos
45mg po daily
Aleglitazar 1
aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
Aleglitazar 2
aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
Aleglitazar 3
aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
Aleglitazar 4
aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
Placebo
Placebo
po daily
Interventions
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Actos
45mg po daily
Placebo
po daily
aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
Eligibility Criteria
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Inclusion Criteria
* type 2 diabetes, diagnosed \>=1 month of screening;
* either drug-naive, or pretreated with a maximum of 2 oral antihyperglycemic agents at submaximal doses;
* HbA1c \<=10.0% at screening, and 7.0-10.0% at pre-randomisation visit.
Exclusion Criteria
* currently or previously treated with insulin, a thiazolidinedione, or a dual Peroxisome Proliferator Activated Receptor (PPAR) agonist;
* clinically significant cardiovascular disease;
* Congestive Heart Failure (CHF) New York Heart Association (NYHA) 3-4.
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
Phoenix, Arizona, United States
Beverly Hills, California, United States
Palm Springs, California, United States
San Diego, California, United States
Chiefland, Florida, United States
Hollywood, Florida, United States
West Palm Beach, Florida, United States
Augusta, Georgia, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Baton Rouge, Louisiana, United States
Baltimore, Maryland, United States
Olive Branch, Mississippi, United States
Hamilton, New Jersey, United States
New Hyde Park, New York, United States
Johnson City, Tennessee, United States
Spokane, Washington, United States
Athens, , Greece
Thessaloniki, , Greece
Hong Kong, , Hong Kong
Bologna, , Italy
Genova, , Italy
Napoli, , Italy
Olbia, , Italy
Pavia, , Italy
Perugia, , Italy
Roma, , Italy
Siena, , Italy
Torino, , Italy
Aguascalientes, , Mexico
Chihuahua City, , Mexico
Cuernavaca, , Mexico
Durango, , Mexico
Guadalajara, , Mexico
Guadalajara, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Pachuca, , Mexico
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Galati, , Romania
Ploieşti, , Romania
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Belgrade, , Serbia
Kragujevac, , Serbia
Niš, , Serbia
Countries
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References
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Henry RR, Lincoff AM, Mudaliar S, Rabbia M, Chognot C, Herz M. Effect of the dual peroxisome proliferator-activated receptor-alpha/gamma agonist aleglitazar on risk of cardiovascular disease in patients with type 2 diabetes (SYNCHRONY): a phase II, randomised, dose-ranging study. Lancet. 2009 Jul 11;374(9684):126-35. doi: 10.1016/S0140-6736(09)60870-9. Epub 2009 Jun 8.
Other Identifiers
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BM17864
Identifier Type: -
Identifier Source: org_study_id