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

Johns Hopkins University

Status and phase

Terminated

Phase 2

Conditions

Glucose Homeostasis

Treatments

Drug: Januvia

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00947011

NA_00018441

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

21 to 75 years old

Volunteers

Accepts Healthy Volunteers

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)