A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator

Inclusion criteria

• Diagnosis of Type 2 diabetes and on either sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 3 months at stable dose
• Males and Females (of non-childbearing potential or who are using dual barrier methods of contraception) between 30 and 75 years of age
• HbA1c must be ≥7.5% and ≤10% at screening
• Fasting Plasma Glucose must be <240 mg/dL at screening

Exclusion criteria

• History of type 1 diabetes
• History of diabetic ketoacidosis
• NYHA Class III or IV cardiac status or hospitalization for congestive heart failure within 6 weeks prior to Visit 1
• Treatment with any non-peroxisome proliferator-activated receptor (non-PPAR) antidiabetic agent, investigational or approved, other than metformin or permitted sulfonylureas within 3 months prior to screening
• Treatment with rosiglitazone, pioglitazone, or any PPAR investigational antidiabetic agent within 6 month prior to screening
• Body mass index >45 kg/m2
• Fasting triglycerides >500 mg/dL
• Uncontrolled hypertension (sitting systolic blood pressure >160 mmHg and/or sitting diastolic blood pressure >100 mmHg
• Presence of diabetic complications, which in the opinion of the investigator, would complicate the subject's participation in the study (i.e., require initiation of new medication)