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

• Status: Completed
• Trial end date: 2008-03-12
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Sitagliptin Phosphate

Criteria

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