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

Primary Purpose

Renal Insufficiency, Hemodialysis

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days

About this trial

This is an interventional treatment trial for Renal Insufficiency focused on measuring Mild, moderate, severe renal insufficiency, End stage renal disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

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

Full Information

NCT ID

NCT00418366

First Posted

January 3, 2007

Last Updated

August 18, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00418366

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

March 2003 (Actual)

Study Completion Date

March 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Insufficiency, Hemodialysis

Keywords

Mild, moderate, severe renal insufficiency, End stage renal disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Safety and tolerability in patients with renal insufficiency

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

17468348

Citation

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. doi: 10.2337/dc06-2545. Epub 2007 Apr 27. No abstract available.

Results Reference

result

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

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