Effects of Oral GLP-1 on Glucose Homeostasis and Appetite Profile in Healthy Male Subjects

Phase 1

Completed

• Conditions: Glucose Homeostasis
• Interventions: Drug: Oral GLP-1; Drug: Placebo

• Registration Number: NCT00822003
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

The investigators aimed to investigate the pharmacokinetic and pharmacodynamic effects of a single dose (2 mg) of oral GLP-1 administered prior to an oral glucose tolerance test (oGTT) in 16 healthy males

Detailed Description

Background: Glucagon like peptide-1 (GLP-1) promotes satiety and reduces food intake. GLP-1 is secreted from intestinal L-cells into the splanchnic circulation, it is (i) subject to rapid breakdown and (ii) submitted to a high liver extraction. Highest concentrations of GLP-1 are therefore found in the splanchnic blood rather than in the systemic circulation. An oral delivery system would mimick the physiological path of endogenous secretion. Objective: We aimed to investigate the pharmacokinetic and pharmacodynamic effects of a single dose (2 mg) of oral GLP-1 administered prior to an oral glucose tolerance test (oGTT) in 16 healthy males.

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-06
• Study Completion: 2008-09
• Status Verified: 2009-01
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-13
• Last Update Submitted: 2009-01-13
• Study First Posted: 2009-01-14
• Last Update Posted: 2009-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

• healthy male subjects
• no gastrointestinal or endocrine disorder

Exclusion Criteria

• females
• alcohol or drug abuse
• active virus hepatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Oral GLP-1	Human GLP-1
2	Placebo	Placebo tablet

Trial Locations

Locations (1)

Clinical Research Center, University Hospital Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland