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

Study Overview
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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.

Official Title
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A Randomized Clinical Trial to Evaluate Glucose-Dependent Insulinotropic Effects of a Single Dose of a DPP-4 Inhibitor in Lean Healthy Males

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: sitagliptin
* Drug: Comparator: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitagliptin/Sitagliptin/Placebo<br>Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods | Drug: sitagliptin<br>* Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.<br>* Other names: MK0431;Drug: Comparator: Placebo<br>* Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.<br>|
| Experimental: Sitagliptin/Placebo/Sitaglipitin<br>Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods | Drug: sitagliptin<br>* Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.<br>* Other names: MK0431;Drug: Comparator: Placebo<br>* Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.<br>|
| Experimental: Placebo/Sitagliptin/Sitagliptin<br>Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods | Drug: sitagliptin<br>* Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.<br>* Other names: MK0431;Drug: Comparator: Placebo<br>* Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose | ISR was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters. | 190 minutes to 340 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose | Glucose Infusion Rate required to maintain the target glucose level of 160 milligrams / deciliter (mg/dL) ; GIR was normalized to subject's body weight (kg). | 190 minutes to 340 minutes |