A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy
NCT ID: NCT01691755
Last Updated: 2016-08-11
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
PHASE3
196 participants
INTERVENTIONAL
2012-11-30
2013-09-30
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
oral doses once a day for 26 weeks
aleglitazar
aleglitazar
150 mcg orally once a day for 26 weeks
Interventions
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Placebo
oral doses once a day for 26 weeks
aleglitazar
150 mcg orally once a day for 26 weeks
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of diabetes mellitus, type 2 within 12 months prior to screening
* Patients who have not received a anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months in the past
* HbA1c \>/=7% and \</=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
* Fasting plasma glucose \</=240 mg/dL at pre-randomization visit
* Agreement to maintain diet and exercise habits during the study
Exclusion Criteria
* Any previous treatment with thiazolidinedione or a dual peroxisome proliferator activated receptor (PPAR) agonist
* Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
* Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening
18 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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Chino, California, United States
Los Angeles, California, United States
Santa Ana, California, United States
Thousand Oaks, California, United States
Upland, California, United States
West Hills, California, United States
Boynton Beach, Florida, United States
Cooper City, Florida, United States
Coral Gables, Florida, United States
Jacksonville, Florida, United States
Kissimmee, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Avon, Indiana, United States
City of Saint Peters, Missouri, United States
Greensboro, North Carolina, United States
Portland, Oregon, United States
Altoona, Pennsylvania, United States
Scranton, Pennsylvania, United States
Tipton, Pennsylvania, United States
Greer, South Carolina, United States
Knoxville, Tennessee, United States
Spokane, Washington, United States
Aguascaliente, , Mexico
Cuernavaca, , Mexico
Culiacán, , Mexico
Durango, , Mexico
Durango, , Mexico
Guadalajara, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Pachuca, , Mexico
Querétaro, , Mexico
Tampico, , Mexico
Countries
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References
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Henry RR, Buse JB, Wu H, Durrwell L, Mingrino R, Jaekel K, El Azzouzi B, Andjelkovic M, Herz M. Efficacy, safety and tolerability of aleglitazar in patients with type 2 diabetes: pooled findings from three randomized phase III trials. Diabetes Obes Metab. 2015 Jun;17(6):560-565. doi: 10.1111/dom.12455. Epub 2015 Apr 8.
Other Identifiers
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BC28034
Identifier Type: -
Identifier Source: org_study_id
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