A Study on the Effect of Kidney Disease on a Diabetes Medication - Full Text View

Purpose

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

Condition	Intervention	Phase
Renal Insufficiency Hemodialysis	Drug: MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days	Phase I

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Sitagliptin phosphate Sitagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study

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

Further study details as provided by Merck:

Primary Outcome Measures:

Determination of the pharmacokinetics of MK0431 (sitagliptin phosphate) in patients with renal insufficiency compared to healthy volunteers

Secondary Outcome Measures:

Estimated Enrollment:	30
Study Start Date:	January 2003

Eligibility

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418366

Sponsors and Collaborators

Merck

Investigators


Study Director:	Medical Monitor	Merck

More Information

Study ID Numbers:	2006_562
First Received:	January 3, 2007
Last Updated:	January 3, 2007
ClinicalTrials.gov Identifier:	NCT00418366
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Mild, moderate, severe renal insufficiency

End stage renal disease

Study placed in the following topic categories:

Renal Insufficiency

Urologic Diseases

Diabetes Mellitus

Kidney Failure, Chronic

Kidney Diseases

Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Pharmacologic Actions

Protease Inhibitors

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00418366