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

April 27, 2015 updated by: Merck Sharp & Dohme LLC

A Randomized, 4-Period Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Sequence 1
A-B-C-C
Other: Comparator: Treatment A
No Treatment
Drug: Comparator: Treatment B
single dose administration of exenatide 5ug by subcutaneous injection
Drug: Comparator: Treatment C
single dose administration of exenatide 10ug by subcutaneous injection
Procedure: Comparator: graded glucose infusion
A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods.
Experimental: Treatment Sequence 2
B-C-A-C
Other: Comparator: Treatment A
No Treatment
Drug: Comparator: Treatment B
single dose administration of exenatide 5ug by subcutaneous injection
Drug: Comparator: Treatment C
single dose administration of exenatide 10ug by subcutaneous injection
Procedure: Comparator: graded glucose infusion
A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods.
Experimental: Treatment Sequence 3
C-A-B-C
Other: Comparator: Treatment A
No Treatment
Drug: Comparator: Treatment B
single dose administration of exenatide 5ug by subcutaneous injection
Drug: Comparator: Treatment C
single dose administration of exenatide 10ug by subcutaneous injection
Procedure: Comparator: graded glucose infusion
A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods.
Experimental: Treatment Sequence 4
A-C-B-C
Other: Comparator: Treatment A
No Treatment
Drug: Comparator: Treatment B
single dose administration of exenatide 5ug by subcutaneous injection
Drug: Comparator: Treatment C
single dose administration of exenatide 10ug by subcutaneous injection
Procedure: Comparator: graded glucose infusion
A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods.
Experimental: Treatment Sequence 5
B-A-C-C
Other: Comparator: Treatment A
No Treatment
Drug: Comparator: Treatment B
single dose administration of exenatide 5ug by subcutaneous injection
Drug: Comparator: Treatment C
single dose administration of exenatide 10ug by subcutaneous injection
Procedure: Comparator: graded glucose infusion
A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods.
Experimental: Treatment Sequence 6
C-B-A-C
Other: Comparator: Treatment A
No Treatment
Drug: Comparator: Treatment B
single dose administration of exenatide 5ug by subcutaneous injection
Drug: Comparator: Treatment C
single dose administration of exenatide 10ug by subcutaneous injection
Procedure: Comparator: graded glucose infusion
A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose)
Time Frame: 0-160 minutes after start of infusion
0-160 minutes after start of infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
safety and tolerability of a graded glucose infusion procedure measured by the number of clinical adverse experiences
Time Frame: 11 weeks
11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

November 25, 2009

First Submitted That Met QC Criteria

November 25, 2009

First Posted (Estimate)

November 30, 2009

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 0000-099
  • 099
  • 2009_697

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Comparator: Treatment A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe