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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
302
Aleglitazar 150 mcg po daily for 52 weeks
Pioglitazone 45 mg po daily for 52 weeks
Renal function: estimated glomerular filtration rate
Time frame: Week 60
Safety, Tolerability: Adverse events (AEs), laboratory parameters
Time frame: AEs: Throughout study, laboratory assessments: Week 2, 4, 8, 12, 16, 20, 26, 39, 52, 56, 60
Renal function: estimated glomerular filtration rate
Time frame: Week 52
Effect on blood hemoglobin
Time frame: Week 52
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Camperdown, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Brisbane, Queensland, Australia
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Elizabeth Vale, South Australia, Australia
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Richmond, South Australia, Australia
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Launceston, Tasmania, Australia
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Melbourne, Victoria, Australia
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Fortaleza, Ceará, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
...and 70 more locations