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

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. Identifier: NCT00947011
Recruitment Status : Terminated (PI left JHU)
First Posted : July 27, 2009
Results First Posted : July 12, 2017
Last Update Posted : July 12, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
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 or disease Intervention/treatment Phase
Glucose Homeostasis Drug: Placebo Drug: Januvia Phase 2

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  (Clinical Trial)
Actual Enrollment : 12 participants
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
Actual Study Start Date : March 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Insulin Release Rate and Hepatic Glucose Release [ Time Frame: One year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00947011

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

Responsible Party: Johns Hopkins University Identifier: NCT00947011     History of Changes
Other Study ID Numbers: NA_00018441
First Posted: July 27, 2009    Key Record Dates
Results First Posted: July 12, 2017
Last Update Posted: July 12, 2017
Last Verified: June 2017

Keywords provided by Johns Hopkins University:
Healthy volunteers

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