Efficacy of Pioglitazone and Glimepiride Combination Therapy in Treating Subjects With Type 2 Diabetes Mellitus.

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Glimepiride; Pioglitazone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.