NCT00822003

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
Last Updated

January 14, 2009

Status Verified

January 1, 2009

Enrollment Period

4 months

First QC Date

January 13, 2009

Last Update Submit

January 13, 2009

Conditions

Glucose Homeostasis

Keywords

GLP-1insulinglucose

Outcome Measures

Secondary Outcomes (1)

  • Glucagon secretion GH release adverse events

Study Arms (2)

1

ACTIVE COMPARATOR

Human GLP-1

Drug: Oral GLP-1

2

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo

Interventions

Oral GLP-1DRUG

GLP-1 tablet (2mg)

1
PlaceboDRUG

Control tablet

2

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male subjects
  • no gastrointestinal or endocrine disorder

You may not qualify if:

  • females
  • alcohol or drug abuse
  • active virus hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center, University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Christoph Beglinger, MD

    Clinical Research Center, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

February 1, 2008

Primary Completion

June 1, 2008

Study Completion

September 1, 2008

Last Updated

January 14, 2009

Record last verified: 2009-01

Locations

CH(1)