A Study on the Effect of Kidney Disease on a Diabetes Medication (0431-008) (NCT00418366) | Clinical Trial Compass
CompletedPhase 1
A Study on the Effect of Kidney Disease on a Diabetes Medication (0431-008)
24 participantsStarted 2003-01
Plain-language summary
A study to evaluate the effect of kidney disease, from mild to severe disease, on a diabetes medication
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Determination of the pharmacokinetics of MK0431 (sitagliptin phosphate) in patients with renal insufficiency compared to healthy volunteers