A Method to Evaluate Glucose-Dependent Insulin Secretion in Healthy Males (MK-0431-179)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-12

Study Completion Date

2009-07-21

Brief Summary

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This study will evaluate the effect of a single dose of sitagliptin on glucose dependent insulin secretion using a meal tolerance test (MTT) during a hyperglycemic clamp (HCG) procedure.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sitagliptin/Sitagliptin/Placebo

Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods

Group Type EXPERIMENTAL

sitagliptin

Intervention Type DRUG

Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.

Comparator: Placebo

Intervention Type DRUG

Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.

Sitagliptin/Placebo/Sitaglipitin

Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods

Group Type EXPERIMENTAL

sitagliptin

Intervention Type DRUG

Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.

Comparator: Placebo

Intervention Type DRUG

Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.

Placebo/Sitagliptin/Sitagliptin

Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods

Group Type EXPERIMENTAL

sitagliptin

Intervention Type DRUG

Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.

Comparator: Placebo

Intervention Type DRUG

Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.

Interventions

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sitagliptin

Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.

Intervention Type DRUG

Comparator: Placebo

Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.

Intervention Type DRUG

Other Intervention Names

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sitagliptin phosphate MK0431

Eligibility Criteria

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Inclusion Criteria

* Subject is an Asian Indian male between 18 to 45 years of age
* Subject is in good health
* Subject is a nonsmoker or has not used nicotine-containing products for six months
* Subject is willing to avoid strenuous activity

Exclusion Criteria

* Subject has a history of stroke, seizures, or major neurological disorders
* Subject has irritable bowel disease or recurrent nausea, vomiting, diarrhea, or abdominal pain
* Subject has a history of high blood pressure requiring treatment
* Subject has history of cancer
* Subject has a history of diabetes

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes