A Study on the Effect of Kidney Disease on a Diabetes Medication (0431-008)

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A study to evaluate the effect of kidney disease, from mild to severe disease, on a diabetes medication

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria :

• Male and non-pregnant females with a clinical diagnosis of renal insufficiency with mild, moderate, severe or end stage renal disease on hemodialysis

• A body mass index of less than 40 kg per meter squared (body weight in kg divided by height in meters squared)

• Smokes less than 10 cigarettes/day

Exclusion Criteria :

• Patients with uncontrolled diabetes or uncontrolled congestive heart failure

• Patient has abnormal prestudy laboratory measurements including serum potassium or white blood counts

• Patient has systolic blood pressure below 100 mm Hg or above 180 mm Hg

• Patient has diastolic blood pressure less than 50 mm Hg systolic or above 100 mmHg