Status:
COMPLETED
Efficacy of Pioglitazone and Insulin in Treating Subjects With Type 2 Diabetes Mellitus and Renal Failure.
Lead Sponsor:
Takeda
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
Brief 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.
Detailed Description
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00770640
Start Date
August 1 2008
End Date
June 1 2010
Last Update
September 1 2010
Active Locations (9)
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1
Schwetzingen, Baden-Wurttemberg, Germany
2
Wiesbaden, Hesse, Germany
3
Bottrop, North Rhine-Westphalia, Germany
4
Düsseldorf, North Rhine-Westphalia, Germany