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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: January 3, 2007
Last updated: August 18, 2015
Last verified: August 2015
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
Intervention Model: Parallel Assignment
Masking: None (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:

Further study details as provided by Merck Sharp & Dohme Corp.:

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

Enrollment: 24
Study Start Date: January 2003
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00418366

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00418366     History of Changes
Other Study ID Numbers: 0431-008
Study First Received: January 3, 2007
Last Updated: August 18, 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Mild, moderate, severe renal insufficiency
End stage renal disease

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 17, 2017