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

Glucose Homeostasis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00947011
• Other study ID #: NA_00018441
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 24, 2009
• Last updated: March 25, 2010
• Start date: March 2009
• Est. completion date: May 2011

Study information

• Verified date: March 2010
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: May 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Glucose Homeostasis

Intervention

Drug:
• Placebo
1 tablet 100 mg once a day
• Januvia
1 tablet 100 mg once a day

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin release and hepatic glucose production rate.		One year	No
Secondary	Peripheral glucose utilization and glucagon release		one year	No