Efficacy of Pioglitazone/Metformin Combination Therapy in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia.

Exclusion Criteria

• •Type 1 diabetes mellitus.
• •Insulin-dependent type 2 diabetes mellitus.
• •Treatment or history of treatment with any insulin formulation other than emergency for more than 2 weeks.
• •Treatment with other oral antidiabetic drugs in addition to metformin within the last 12 weeks.
• •Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures.
• •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:
• •* Heparin (and heparin-like drugs)
• •* coumarin
• •* phenprocoumon
• •* hirudin
• •* Protein C
• •* Fondaparinux
• •* antithrombin III
• •* Peroxisome Proliferation Activating Receptor (gamma) agonists
• •* Treatment within the last 12 weeks with:
• •* fibrates
• •* gemfibrozil
• •* niacin
• •* months
• •* Rifampicin
• •* Changes in dosage of any statin treatment to lower low-density lipoprotein within 2 weeks before study entry and during study participation interval.
• •* Changes in dosage of any anticoagulant treatment with acetyl salicylic acid and/or clopidogrel within 2 weeks before study entry and during study participation interval.
• •* Start of statin and/or anticoagulant treatment during study participation interval.
• •History of severe or multiple allergies and/ or acute severe infections.
• •Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit.
• •Progressive fatal disease.
• •Any elective surgery during study participation.
• •History of drug or alcohol abuse within the last 5 years.
• •A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (alanine aminotransferase and/or aspartate aminotransferase greater than 2.5 times the upper limit of the normal reference range), renal (serum creatinine greater than 1.2 mg/dL in women and greater than 1.5 mg/dL in men, glomerular filtration rate less than 60 ml/min as estimated by the Cockroft-Gault formula), neurological, psychiatric and/or hematological disease as judged by the investigator, history of macular edema.
• •Blood donation within the last 30 days.