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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00418366
Recruitment Status : Completed
First Posted : January 4, 2007
Last Update Posted : August 19, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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
Study Start Date : January 2003
Actual Primary Completion Date : March 2003
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Primary Outcome Measures :
  1. Determination of the pharmacokinetics of MK0431 (sitagliptin phosphate) in patients with renal insufficiency compared to healthy volunteers

Secondary Outcome Measures :
  1. Safety and tolerability in patients with renal insufficiency

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00418366

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00418366    
Other Study ID Numbers: 0431-008
First Posted: January 4, 2007    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015
Keywords provided by Merck Sharp & Dohme Corp.:
Mild, moderate, severe renal insufficiency
End stage renal disease
Additional relevant MeSH terms:
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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