GASOLIN

CompletedPhase NA

GIP/GLP-1 Co-Activity in Subjects With Obesity: Lowering of Food Intake

Lead sponsor

University Hospital, Gentofte, Copenhagen

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI 25-40•Male

Primary endpoint

•Food intake

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02598791

Org study IDH-15008790 (GASOLIN)

Timeline

Milestones

Study start2015-10-01actual

Study first posted2015-11-06estimated

Primary completion2016-06-20actual

Study completion2016-06-20actual

Last update posted2018-12-06actual

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age25 Years

Maximum age70 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Caucasian men

•Age between 25 and 70 years

•Body mass index (BMI) between 25 and 40 kg/m2

Exclusion criteria

•Diabetes or prediabetes (defined as glycated haemoglobin (HbA1c) ≥ 43 mmol/mol)

•Anaemia (defined as haemoglobin < 8.3 mmol/l)

•Any gastrointestinal disease that may interfere with the endpoint variables

•Anorexia, bulimia or binge eating disorder

•Allergy or intolerance to ingredients included in the standardised meals

•Tobacco smoking

•Any regular drug treatment that cannot be discontinued for minimum 18 hours

•Any physical or psychological condition that the investigator feels would interfere with trial participation

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Glycemic / diabetes

Cardiometabolic biomarkers

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Insulin

Time frame:-30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min

descriptive

Secondary/protocol endpoint

C-peptide level

Time frame:-30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min

descriptive

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Cholesterol and FFA

Time frame:-30, 0, 30, 60, 90, 120, 180, 240 min

descriptive

Other (unclassified)

9 endpoints

Primary/protocol endpoint/low confidence

food intake

Time frame:250-280 min

descriptive