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AleNephro: Aleglitazar vs Pioglitazone in T2D with Renal Impairment
NCT01043029Phase 2
Key facts
- Status
- Completed
- Start
- May 2010
- Primary completion
- Jul 2012
- Countries
- 13
- Sponsor
- Roche
- Modality
- Small Molecules
- Drugs
- aleglitazar
- Conditions
- type 2 diabetes mellitus (T2DM)diabetic nephropathy (DN)
01
Overview
Phase 2, randomised, double-blind trial of aleglitazar in type 2 diabetes mellitus (T2DM) and diabetic nephropathy (DN) (2 arms), sponsored by Roche. Primary endpoint: estimated glomerular filtration rate at Week 60. Started May 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Aleglitazar
Aleglitazar 150 mcg po daily
Pioglitazone
Pioglitazone 45 mg po daily
03
Who it enrols
Adult patients with Type 2 Diabetes and moderately impaired kidney function, BMI 25-35, drug naive or on stable dose of up to 2 antihyperglycemics. Excludes prior TZD or insulin use, recent fibrate use, or other renal diseases.
04
Endpoints
Primary
estimated glomerular filtration rate
Secondary
Adverse events
Laboratory parameters
estimated glomerular filtration rate
blood hemoglobin
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