Dose-response Study of Exendin-9,39 on Glucose Metabolism

Phase 1

Completed

• Conditions: Pancreatic Effects of 9,39-Exendin and 9,36-GLP-1
• Interventions: Drug: saline infusion; Drug: GLP-1-9,36 infusion; Drug: Exendin-9,39 at low dose; Drug: Exendin-9,39 at high dose

• Registration Number: NCT01218633
• Lead Sponsor: Adrian Vella

Brief Summary

Multiple studies have examined the effect of endogenous GLP-1 secretions by using a competitive antagonist of GLP-1 - Exendin-9,39 - infused at rates of 300pmol/kg/min. However, the presence of an effect does not necessarily imply that this effect is due to the blockade of the endogenous GLP-1 actions at the receptor. It is possible that the supraphysiologic concentrations of Exendin may have effects of its own. To examine the effect of Exendin on glucose metabolism the investigators propose a dose-response study to determine whether the compound has effects in a dose-dependent fashion.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-11
• Study Start: 2011-05
• Primary Completion: 2012-07
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-18
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline	saline infusion	-
GLP-1-(9,36)-amide	GLP-1-9,36 infusion	-
Exendin-9,39 @30pmol/kg/min	Exendin-9,39 at low dose	-
Exendin-9,39 @300pmol/kg/min	Exendin-9,39 at high dose	-

Primary Outcome Measures

Name	Time	Method
Insulin Secretion	over 360 minutes of study

Secondary Outcome Measures

Name	Time	Method
glucagon secretion	over 360 minutes of study

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States