Efficacy and Safety Study of Pioglitazone Combined With Metformin on Metabolic Syndrome in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to determine the efficacy of pioglitazone taken with metformin on high-density lipoprotein cholesterol in subjects with Type 2 Diabetes.

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

Details

• Lead Sponsor: Takeda
• Treatments: Metformin; Pioglitazone

Criteria

Inclusion Criteria:

• Diagnosis of Type 2 Diabetes Mellitus.

• Has glycosylated hemoglobin levels between 6.0% and 8.0%.

• Treatment with metformin (2,000 to 3,000 mg daily) for at least 3 months.

• Has reduced high-density lipoprotein cholesterol levels less than 40 mg/dl in males and less than 50 mg/dl in females, irrespective of treatment with statins.

• Has central obesity defined as a waist circumference greater than or equal to 94 cm for men and greater than or equal to 80 cm for females.

• 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:

• Has a diagnosis of Type 1 Diabetes Mellitus.

• 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:

• other oral antidiabetic drugs than metformin or with insulin in the 3 months preceding study entry.

• Fibrates

• Rifampicin

• Has any disease with malabsorption.

• Has acute or chronic pancreatitis.

• Has familial polyposis coli.

• Has a medical history of myocardial infarction, transient ischemic attacks or stroke in the past 6 months.

• Has heart failure as defined by the New York Heart Association classification I-IV.

• Has significant liver impairment, with an alanine aminotransferase level greater than 2.5 the upper limit of normal range.

• Has significant renal impairment, with a serum creatinine level greater than 1.5 mg/dl for men and greater than 1.2 mg/dl for women.

• Has anemia of any etiology (defined as hemoglobin levels less than 10.5 g/dL) or any other hematologic disease.

• Has a diagnosis or suspicion of neoplastic disease.

• History of chronic alcohol or drug abuse.

• Known allergy, sensitivity or intolerance to the study drugs and their formulation ingredients.

• Participation in another trial in the 3 months preceding study entry.