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

University Hospital Basel

Status and phase: Completed; Phase 2; Phase 1

Conditions: Glucose Homeostasis

Treatments: Drug: Oral GLP-1; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00822003

EKBB 127/07, Amendment 1

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy male subjects
• no gastrointestinal or endocrine disorder

Exclusion criteria

• females
• alcohol or drug abuse
• active virus hepatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Human GLP-1

Treatment:

Drug: Oral GLP-1

2

Placebo Comparator group

Description:

Placebo tablet

Treatment:

Drug: Placebo