Hemodialysis, Renal Insufficiency
Conditions
Keywords
Mild, moderate, severe renal insufficiency, End stage renal disease
Brief summary
A study to evaluate the effect of kidney disease, from mild to severe disease, on a diabetes medication
Interventions
DRUGMK0431, sitagliptin phosphate / Duration of Treatment : 1 Days
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the pharmacokinetics of MK0431 (sitagliptin phosphate) in patients with renal insufficiency compared to healthy volunteers | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability in patients with renal insufficiency | — |
Outcome results
None listed