Efficacy of Pioglitazone and Fortamet Combination Therapy in Subjects With Type 2 Diabetes

Inclusion Criteria * 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 * Diagnosed with type 2 diabetes and must have received appropriate counseling on lifestyle modification for type 2 diabetes including diet and exercise. * If taking metformin monotherapy or metformin and sulfonylurea combination therapy, has a glycosylated hemoglobin greater than or equal to 7.5% and less than or equal to 9.0% at screening and randomization. * If naïve or taking sulfonylurea monotherapy has an glycosylated hemoglobin greater than or equal to 8.5% and less than or equal to 10.0% at screening and greater than or equal to 7.5% and less than or equal to 9.0% at randomization. Exclusion Criteria * Has type 1 diabetes mellitus * Currently taking any thiazolidinedione or have taken any thiazolidinedione within 12 weeks prior to screening * Has congestive heart failure; has a triglyceride level greater than 500 mg per dL * Diastolic blood pressure greater than 100 mmHg or a systolic pressure greater than 160 mmHg * Body mass index greater than or equal to 42 kg/m2 (weight /height2) * Alanine transaminase level greater than or equal to 2.5 times the upper limit of normal, active liver disease, or jaundice. * Male subjects who have a serum creatinine level greater than or equal to 1.5 mg per dL; female subjects who have a serum creatinine level greater than or equal to 1.4 mg per dL at the screening visit and at randomization. * Currently using insulin or has used insulin 3 months prior to Screening * Acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma. * 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: * Chronically used oral or parenteral glucocorticoids (eg, prednisone, cortisone, hydrocortisone, dexamethasone) * Niacin greater than 200 mg per day, including niacin-containing products such as Advicor - 3 months prior to screening and during the study * Chronically used steroid-joint injections - 3 months prior to screening and during the study * Thiazolidinediones - 3 months prior to screening and during the study * Insulin - 3 months prior to screening * Other oral antidiabetic medications (eg, nateglinide \[Starlix\], acarbose \[Precose\]) with the exception of sulfonylurea - 3 months prior to screening and during the study * Metformin - Fortamet Stabilization and during the study