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A Study on the Effect of Kidney Disease on a Diabetes Medication

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00418366
First received: January 3, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  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 1

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

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:
  • Safety and tolerability in patients with renal insufficiency

Estimated Enrollment: 30
Study Start Date: January 2003
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

No publications provided

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

Keywords provided by Merck:
Mild, moderate, severe renal insufficiency
End stage renal disease

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013