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

Merck Sharp & Dohme LLC12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

sitagliptinDRUG

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

Comparator: PlaceboDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 190 minutes to 340 minutes

Secondary Outcomes

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).

Time frame: 190 minutes to 340 minutes

Data from ClinicalTrials.gov

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