Sitagliptin Added-on to Insulin Study (0431-051)

A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin (MK0431) to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Therapy (Alone or In Combination With Metformin)

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on insulin or insulin/metformin combination therapy.

Inclusion Criteria:

• Patient has type 2 diabetes mellitus
• Patient is poorly controlled while on insulin or insulin and metformin

Exclusion Criteria:

• Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
• Patient is taking oral antidiabetic agents other than metformin during the past 3 months
• Patient is currently on treatment with daily use of pre-prandial short-acting or rapid-acting insulin