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

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418366
• Other study ID #: 0431-008
• Secondary ID: 2006_562
• Status: Completed
• Phase: Phase 1
• First received: January 3, 2007
• Last updated: August 18, 2015
• Start date: January 2003
• Est. completion date: March 2003

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Bergman 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. Epub 2007 Apr 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the pharmacokinetics of MK0431 (sitagliptin phosphate) in patients with renal insufficiency compared to healthy volunteers
Secondary	Safety and tolerability in patients with renal insufficiency