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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00947011
First received: July 24, 2009
Last updated: March 25, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Glucose Homeostasis
Drug: Placebo
Drug: Januvia
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Insulin release and hepatic glucose production rate. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peripheral glucose utilization and glucagon release [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: March 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar pill Drug: Placebo
1 tablet 100 mg once a day
Other Name: Sugar pill
Active Comparator: Januvia Drug: Januvia
1 tablet 100 mg once a day
Other Name: Sitaglipton

Detailed Description:

The purpose of the present proposal is to 1) examine the role of 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, we 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, we will also test the role of the latter by infusing GLP-1m when the volunteers are being treated with DPP-4 inhibitors.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947011

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Dariush Elahi, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Dariush Elahi, PhD, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00947011     History of Changes
Other Study ID Numbers: NA_00018441
Study First Received: July 24, 2009
Last Updated: March 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
Healthy volunteers
GLP-1
Januvia
Sitagliptin

Additional relevant MeSH terms:
Glucagon-Like Peptide 1
Glucagon
Sitagliptin
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents

ClinicalTrials.gov processed this record on April 16, 2014