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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2003-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Renal Insufficiency Hemodialysis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No