Effects of Oral GLP-1 on Glucose Homeostasis and Appetite Profile in Healthy Male Subjects (No)

This study has been completed.
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00822003
First received: January 13, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted

January 13, 2009
January 13, 2009
February 2008
June 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Glucagon secretion GH release adverse events [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Oral GLP-1 on Glucose Homeostasis and Appetite Profile in Healthy Male Subjects
Effects of Oral GLP-1 on Glucose Homeostasis and Appetite Profile Following an Oral Glucose Tolerance Test in Healthy Male Subjects

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

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Glucose Homeostasis
  • Drug: Oral GLP-1
    GLP-1 tablet (2mg)
  • Drug: Placebo
    Control tablet
  • Active Comparator: 1
    Human GLP-1
    Intervention: Drug: Oral GLP-1
  • Placebo Comparator: 2
    Placebo tablet
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
September 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy male subjects
  • no gastrointestinal or endocrine disorder

Exclusion Criteria:

  • females
  • alcohol or drug abuse
  • active virus hepatitis
Male
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00822003
EKBB 127/07, Amendment 1
No
Beglinger Christoph, Prof. Dr.med., University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Principal Investigator: Christoph Beglinger, MD Clinical Research Center, University Hospital Basel
University Hospital, Basel, Switzerland
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP