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

Phase 2

Terminated

• Conditions: Glucose Homeostasis
• Interventions: Drug: Placebo; Drug: Januvia

• Registration Number: NCT00947011
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2017-05-01
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-29
• Last Update Submitted: 2017-06-29
• Results First Posted: 2017-07-12
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Januvia	Januvia	-

Primary Outcome Measures

Name	Time	Method
Insulin Release Rate and Hepatic Glucose Release	One year

Secondary Outcome Measures

Name	Time	Method
Peripheral Glucose Utilization and Peripheral Glucagon Release	one year

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States