Overview

This trial is active, not recruiting.

Condition glucose homeostasis
Treatments placebo, januvia
Phase phase 2
Sponsor Johns Hopkins University
Collaborator Merck Sharp & Dohme Corp.
Start date March 2009
End date May 2010
Trial size 64 participants
Trial identifier NCT00947011, NA_00018441

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose health services research
Arm
(Placebo Comparator)
placebo Sugar pill
1 tablet 100 mg once a day
(Active Comparator)
januvia Sitaglipton
1 tablet 100 mg once a day

Primary Outcomes

Measure
Insulin release and hepatic glucose production rate.
time frame: One year

Secondary Outcomes

Measure
Peripheral glucose utilization and glucagon release
time frame: one year

Eligibility Criteria

Male or female participants from 21 years up to 75 years old.

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

Additional Information

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
Principal investigator Dariush Elahi, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by Johns Hopkins University.