A Phase 2 interventional study of Pioglitazone and insulin and Insulin in Diabetes Mellitus, sponsored by Takeda. Completed at 9 sites in Germany. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-09-01.
Sponsored by Takeda · Phase 2, Interventional, and Treatment
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.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 40 is close to the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
(and variable insulin therapy)
Drug: Pioglitazone and insulin
(and variable insulin therapy)
Drug: Insulin
Pioglitazone 30 mg, tablets, orally, once daily and variable insulin therapy for up to 24 weeks.
Also known as: ACTOS®, AD-4833
Pioglitazone placebo-matching tablets, orally, once daily and variable insulin therapy for up to 24 weeks.
Change of total daily Insulin Dose.
Time frame: Week 24 or Final Visit.
Individual insulin doses to assess the number of patients with insulin reduction of greater than or equal to 30%.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in Glycosylated Hemoglobin.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in Glucose.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in Insulin.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in C-peptide.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in Intact Proinsulin.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in Adiponectin.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in Angiotensin.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in Relaxin.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in fetuin A.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in Carbonyl Protein.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in Myeloperoxidase.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in Matrix-Gla Protein.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in High Sensitivity C-reactive Protein.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in Cholesterol.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in High-Density Lipoprotein.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in Low-Density Lipoprotein.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in Oxidized Low-Density Lipoprotein.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in Triglycerides.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in Matrix Metalloproteinase -9.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in Monocyte Chemoattractant Protein -1.
Time frame: Weeks 12 and 24 or Final Visit.
Change from Baseline in E-selectin.
Time frame: Weeks 12 and 24 or Final Visit.
Pioglitazone in serum.
Time frame: Week 12.
Change from Baseline in intact Parathyroid Hormone.
Time frame: Weeks 12 and 24 or Final Visit.
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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