Dipeptidyl Peptidase-4 Inhibition on Glucagon-like Peptide-1 (GLP-1)

June 29, 2017 updated by: Johns Hopkins University

The Effect of Dipeptidyl Peptidase-4 Inhibition on GLP-1 Induced Insulin Secretion and Glucose Turnover During Mild Stable Hyperglycemia in Young and Old Normal Volunteers

This research is being done to evaluate the effect of glucagon-like peptide-1 (GLP-1, a naturally occurring hormone) on insulin release and to examine whether there is extra insulin release when GLP-1 is not allowed to be rapidly inactivated.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of the present proposal is to 1) examine the role of dipeptidyl peptidase (DPP-4) inhibition on insulin release during a hyperglycemic clamp while GLP-1 is being infused and, 2) further elucidate the role of the metabolite of GLP-1, that is GLP-1 9-36 amide (GLP-1m). During stable and very reproducible elevated plasma glucose levels the effect of increased active incretin levels with DPP-4 inhibitors should result in increased plasma insulin levels. Therefore the aim of this protocol is to document whether plasma insulin levels are increased following GLP-1 infusion in the presence or absence of DPP-4 inhibitors. Additionally, the investigators have shown that some improvement in glucose homeostasis during GLP-1 administration is due in part to the metabolite of GLP-1, i.e. GLP-1 (9-36) amide (GLP-1m). Therefore, the investigators will also test the role of the latter by infusing GLP-1m when the volunteers are being treated with DPP-4 inhibitors.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center

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

21 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hct level of at least 34% for women and 36% for men
  • Women of non-bearing potential and women of childbearing potential using adequate contraception
  • Serum creatine level of less than 1.7 mg/dl

  • Four groups:

    • Age 21-45 (BMI between 18.50-24.99) & (BMI between 30-35)
    • Age greater than 65 years (BMI between 18.50-24.99) & (BMI between 30-35)

Exclusion Criteria:

  • Pregnant and/or lactating females
  • Women of childbearing potential not willing to use adequate contraception
  • Hct below inclusion criteria
  • Serum creatine level greater than 1.8 mg/dl
  • Age less than 21 and age between 46-64
  • Diabetes mellitus
  • BMI less than 18 and BMI greater than 35

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: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
1 tablet 100 mg once a day
Other Names:
  • Sugar pill
ACTIVE_COMPARATOR: Januvia
Drug: Januvia
1 tablet 100 mg once a day
Other Names:
  • Sitagliptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insulin Release Rate and Hepatic Glucose Release
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Peripheral Glucose Utilization and Peripheral Glucagon Release
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

Johns Hopkins University

Collaborators

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 (ACTUAL)

March 1, 2009

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

July 24, 2009

First Submitted That Met QC Criteria

July 24, 2009

First Posted (ESTIMATE)

July 27, 2009

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2017

Last Update Submitted That Met QC Criteria

June 29, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00018441

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.

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