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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hemodialysis; Renal Insufficiency

Treatments: Drug: MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days

Study type: Interventional

Funder types: Industry

Identifiers

NCT00418366

2006_562

0431-008

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)