A Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose (0000-099)(COMPLETED)

Merck Sharp & Dohme LLC12 enrolled

Overview

A four-period study to evaluate if the grade glucose infusion procedure will be able to detect an increase in beta-cell glucose sensitivity from exenatide compared to no treatment in healthy subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

Comparator: Treatment AOTHER

No Treatment

Comparator: Treatment BDRUG

single dose administration of exenatide 5ug by subcutaneous injection

Comparator: Treatment CDRUG

single dose administration of exenatide 10ug by subcutaneous injection

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is in good health * Subject is a non-smoker Exclusion Criteria: * Subject has irritable bowel disease * Subject has a history of cancer * Subject has a history of hypertension requiring treatment * Subject is unable to refrain from the use of any prescription or non-prescription medication * Subject consumes excessive amounts of alcohol or caffeine * Subject has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

Outcomes

Primary Outcomes

beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose)

Time frame: 0-160 minutes after start of infusion

Secondary Outcomes

safety and tolerability of a graded glucose infusion procedure measured by the number of clinical adverse experiences

Time frame: 11 weeks

Data from ClinicalTrials.gov

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