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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014