A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin Therapy
NCT ID: NCT01691989
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
PHASE3
197 participants
INTERVENTIONAL
2012-12-31
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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PARALLEL
TREATMENT
DOUBLE
Study Groups
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aleglitazar
aleglitazar
150 mcg orally once a day for 26 weeks
placebo
placebo
oral doses once a day for 26 weeks
Interventions
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aleglitazar
150 mcg orally once a day for 26 weeks
placebo
oral doses once a day for 26 weeks
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of diabetes mellitus, type 2
* Patients treated with stable sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 12 weeks prior to screening
* 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 PPAR agonist
* Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
* Any anti-hyperglycemic medication other than sulfonylurea alone or in combination with metformin within 12 weeks prior to screening
* 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
San Diego, California, United States
Santa Ana, California, United States
Jacksonville, Florida, United States
Kissimmee, Florida, United States
St. Petersburg, Florida, United States
Atlanta, Georgia, United States
Avon, Indiana, United States
Bethesda, Maryland, United States
Durham, North Carolina, United States
Morrisville, Pennsylvania, United States
Greer, South Carolina, United States
Dallas, Texas, United States
Richmond, Virginia, United States
Buenos Aires, , Argentina
Caba, , Argentina
Rosario, , Argentina
Bogotá, , Colombia
Floridablanca, , Colombia
Medellin-Antioquia, , Colombia
Guatemala City, , Guatemala
Guatemala City, , Guatemala
Aguascaliente, , Mexico
Celaya, , Mexico
Guadalajara, , Mexico
Guadalajara, , Mexico
Querétaro, , 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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WC28325
Identifier Type: -
Identifier Source: org_study_id