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