Study of Sitagliptin in Older Type 2 Diabetics (0431-047)(COMPLETED)

A Multicenter, Double-Blind, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Sitagliptin in Elderly Patients With Type 2 Diabetes Mellitus

To evaluate the effect of treatment with sitagliptin compared to placebo in elderly patients with type 2 diabetes mellitus who have poor glycemic control with diet and exercise.

Inclusion Criteria:

• Community dwelling patients 65 years of age or older diagnosed with Type 2 Diabetes not controlled with diet and exercise
• Patients must have a HbA1c of 7-10% off medication, or as a result of a protocol wash-out from oral anti-hyperglycemic agents by the qualifying visit

Exclusion Criteria:

• Patients with type 1 diabetes
• History of ketoacidosis or requires insulin use
• Alanine aminotransferase / aspartate aminotransferase > 2.5 X ULN, triglycerides > 600 mg/dL, creatinine clearance < 35 mL/min
• Fasting plasma glucose consistently > 260 mg/dL
• Poorly controlled hypertension