Efficacy of Pioglitazone and Insulin in Treating Subjects With Type 2 Diabetes Mellitus and Renal Failure.

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Insulin; Insulin, Globin Zinc; Pioglitazone

Criteria

Inclusion Criteria:

• Has Type 2 Diabetes Mellitus, and is a patient on insulin treatment for at least 3 months.

• Has a body mass index less than 36 kg/m²

• Has a glycosylated hemoglobin level greater than or equal to 6.0% and less than 10%.

• Patient is on hemo-dialysis with or without residual excretion

• An insulin dose greater than 20 IE/day

Exclusion Criteria:

• Has a history of type 1 diabetes.

• Has acute infections.

• History of hypersensitivity to the study drugs or to drugs with similar chemical structures.

• History of severe or multiple allergies.

• Has a progressive fatal disease other than kidney failure.

• Has a history of drug or alcohol abuse within the last 5 years.

• A history of significant cardiovascular (e.g. Coronary heart failure based on New York Heart Association stage III - IV), respiratory, gastrointestinal, hepatic (e.g. alanine aminotransferase greater than 2.5 times the normal reference range) or hematological disease.

• History of primary hyperaldosteronism

• Acute myocardial infarction, open heart surgery or cerebral event (stroke/transient ischemic attack) within the last year prior to study start.

• Any further antidiabetic treatment except pioglitazone and insulin.

• History of macular edema.

• 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:

• Treatment with any other investigational drug within 3 months before trial entry.

• Treatment with steroids within 3 months before trial entry.

• Treatment with thiazolidinediones within the past 3 months.

• If statin therapy applicable: Change of medication within the last 4 weeks.

• Pre-treatment with gemfibrozil within the last 12 weeks.

• Pre-treatment with rifampicin within the last 12 weeks.

• Has uncontrolled unstable angina.