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

Adrian Vella

Status and phase: Completed; Phase 1

Conditions: Pancreatic Effects of 9,39-Exendin and 9,36-GLP-1

Treatments: Drug: Exendin-9,39 at low dose; Drug: GLP-1-9,36 infusion; Drug: Exendin-9,39 at high dose; Drug: saline infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01218633

10-003435

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Healthy Not on any medication other than thyroid hormone replacement or OCP No history of diabetes No prior upper GI surgery

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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11 participants in 4 patient groups, including a placebo group

Saline

Placebo Comparator group

Treatment:

Drug: saline infusion

GLP-1-(9,36)-amide

Active Comparator group

Treatment:

Drug: GLP-1-9,36 infusion

Exendin-9,39 @30pmol/kg/min

Active Comparator group

Treatment:

Drug: Exendin-9,39 at low dose

Exendin-9,39 @300pmol/kg/min

Active Comparator group

Treatment:

Drug: Exendin-9,39 at high dose