Clinical trial · Interventional
A Study on the Effect of Kidney Disease on a Diabetes Medication (0431-008)
An Open- Label, 2 Part Study to Investigate the Pharmacokinetics, Safety, and Tolerability of MK0431(Sitagliptin Phosphate) in Patients With Varying Degrees of Renal Insufficiency
NCT00418366CI-TRIAL-00018883completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study to evaluate the effect of kidney disease, from mild to severe disease, on a diabetes medication
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hemodialysis | — | UNRESOLVED | — |
| Renal Insufficiency | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determination of the pharmacokinetics of MK0431 (sitagliptin phosphate) in patients with renal insufficiency compared to healthy volunteers
Secondary outcomes (1)
- measure
- Safety and tolerability in patients with renal insufficiency
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTBergman AJ, Cote J, Yi B, Marbury T, Swan SK, Smith W, Gottesdiener K, Wagner J, Herman GA. Effect of renal insufficiency on the pharmacokinetics of sitagliptin, a dipeptidyl peptidase-4 inhibitor. Diabetes Care. 2007 Jul;30(7):1862-4. doi: 10.2337/dc06-2545. Epub 2007 Apr 27. No abstract available. PMID 17468348