Diabetes Mellitus Clinical Trial
Official title:
Comparison of the Effects of Pioglitazone vs. Placebo When Given in Addition to Standard Insulin Treatment in Patients With Type 2 Diabetes Mellitus and Renal Failure
The purpose of this study is to determine the metabolic and cardiovascular effects of pioglitazone, once daily (QD), and insulin combination therapy in subjects with Type 2 Diabetes and Renal Failure.
Patients with type 2 diabetes mellitus and clinically significant kidney disease presenting
with contra-indications for metformin and sulfonylurea drugs are usually treated with
insulin therapy only. While the prolonged pharmacokinetic insulin profile due to delayed
renal insulin elimination already is a hurdle for a successful therapy, impaired kidney
function results in increased oxidative stress and cardiovascular risk, especially in
patients requiring dialysis. Several potential mechanisms may explain this increased
cardiovascular risk, and one, frequent finding is coexistence of several other independent
cardiovascular risk factors including dyslipidemia, hypertension and smoking. In addition,
impaired kidney function is associated with elevated markers of inflammation and other
putative risk factors for cardiovascular events.
The focus of this study is to investigate whether pioglitazone may help improve overall
metabolic and cardiovascular risks in patients with end stage renal disease, and if
pioglitazone can potentially exert positive effects on kidney function in patients with
renal failure requiring dialysis.
The duration of treatment for patients completing the study is approximately 26 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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