Status:
COMPLETED
Efficacy of Pioglitazone and Glimepiride Combination Therapy in Treating Subjects With Type 2 Diabetes Mellitus.
Lead Sponsor:
Takeda
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
30-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the effect of pioglitazone, once daily (QD), and glimepiride combination therapy compared to glimepiride monotherapy in subjects with Type 2 Diabetes.
Detailed Description
Tight glycemic control is mandatory for the prevention and treatment of vascular complications in patients suffering from diabetes mellitus. After onset of Type 2 Diabetes, patients are usually treate...
Eligibility Criteria
Inclusion
- Type 2 Diabetes according to the American Diabetes Association Criteria.
- Treatment with Glimepiride monotherapy (1-3 mg per day) 3 months before entering the study.
- Glycosylated hemoglobin greater than 6.5%, but less than 8.5% and/ or fasting plasma glucose greater than 7 mmol/l within the last 4 weeks.
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Exclusion
- Type 1 Diabetes mellitus.
- History of hypersensitivity to the study drugs or to drugs with similar chemical structures.
- Progressive fatal disease.
- History of drug or alcohol abuse during the last 5 years.
- More than one unexplained episode of severe hypoglycemia within 6 months prior to entering the study.
- A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (alanine aminotransferase greater than 2.5 times the upper limit of the normal reference range), renal (serum creatinine greater than 1.8 mg/dl; glomerular filtration rate less than 40 ml/min as estimated by the Cockroft-Gault formula), neurological, psychiatric and/or hematological disease, history of macular edema.
- Blood donation within the last 30 days.
- 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:
- CYP2C9 inductors
- CYP2C9 inhibitors
- rifampicin
- fluconazole
- drugs used for treating type 2 diabetes (insulin, insulin analogous compounds and oral antidiabetic drugs)
- Pretreatment with thiazolidinediones within the last 12 months.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00770952
Start Date
December 1 2006
End Date
December 1 2008
Last Update
July 5 2010
Active Locations (17)
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1
Villingen-Schwenningen, Baden-Wurttemberg, Germany
2
Aschaffenburg, Bavaria, Germany
3
Ingolstadt, Bavaria, Germany
4
Frankfurt am Main, Hesse, Germany