A Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment
Tracking Information
Start Date ICMJE | April 2010 |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: January 5, 2010) | Renal function: estimated glomerular filtration rate [ Time Frame: Week 60 ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | No Changes Posted |
Current Secondary Outcome Measures ICMJE (submitted: January 5, 2010) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | A Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment |
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Official Title ICMJE | Effects of 0.15 mg Aleglitazar on Renal Function in Patients With Type 2 Diabetes and Moderate Renal Impairment, as Compared to Actos® |
Brief Summary | This multi-center, randomized, double-blind, active controlled, parallel-group study in type 2 diabetes patients with moderate renal impairment will evaluate the effect on renal function and the safety and tolerability of aleglitazar compared with pioglitazone. Patients will be randomized to receive either 150 mcg aleglitazar or 45 mg pioglitazone as daily oral doses. In addition, a diet and exercise plan will also be implemented during the anticipated time on study treatment of 52 weeks. The target sample size is 200-400 patients. |
Detailed Description | |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Diabetes Mellitus, Type 2 |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 300 | ||||
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Estimated Completion Date | February 2013 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Australia, Brazil, Colombia, El Salvador, Germany, Hong Kong, Hungary, Italy, Mexico, Peru, Romania, Russian Federation, Slovakia |
Administrative Information
NCT ID ICMJE | NCT01043029 | ||||
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Responsible Party | Disclosures Group, Hoffmann-La Roche | ||||
Study ID Numbers ICMJE | BC22419, 2009-012270-12 | ||||
Study Sponsor ICMJE | Hoffmann-La Roche | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Hoffmann-La Roche |
Source: http://clinicaltrials.gov/