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

This study has been terminated.
(PI left JHU)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00947011
First Posted: July 27, 2009
Last Update Posted: July 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Johns Hopkins University
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Rate and Hepatic Glucose Release [ Time Frame: One year ]

Secondary Outcome Measures:
  • Peripheral Glucose Utilization and Peripheral Glucagon Release [ Time Frame: one year ]

Enrollment: 12
Actual Study Start Date: March 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo 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: Sitagliptin

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00947011     History of Changes
Other Study ID Numbers: NA_00018441
First Submitted: July 24, 2009
First Posted: July 27, 2009
Results First Submitted: May 1, 2017
Results First Posted: July 12, 2017
Last Update Posted: July 12, 2017
Last Verified: June 2017

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

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