Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)

Exclusion Criteria

• •diagnosed with type 1 diabetes mellitus or has a history of ketoacidosis
• •treatment with insulin, TZDs (excluding rosiglitazone) or any other oral or injected antidiabetic (excluding metformin or Avandamet) within 3 months prior to screening or during study treatment
• •change in lipid-lowering medication within 2 months of screening
• •taken systemic corticosteroids within 1 month prior to screening or during study treatment
• •history of or current/active cardiovascular disease
• •significant current pulmonary conditions
• •significant thyroid disease
• •CPK value \> 3x ULN
• •a female who is pregnant or lactating
• •systolic BP \> 160 mm Hg or a diastolic BP \> 90 mm Hg at screening
• •previous or current history of cancer, other than basal cell or stage 1 squamous cell carcinoma of the skin, that has not been in remission within 5 years prior to randomization
• •liver function tests (ALT, AST, ALP) \> 2 times ULN, or active liver disease at screening
• •history of positive HIV
• •positive hepatitis B test at screening
• •weight loss or gain \>/= 15 lbs within 3 months of screening
• •history of substance abuse (including alcohol abuse) within 2 years prior to screening
• •donated and/or received any blood or blood products within 3 months prior to randomization
• •taken an investigational study medication within 30 days prior to screening or during the study