CompletedPhase NA

Effect of Bile Acid Secretion and Sequestration on GLP-1 Secretion

Lead sponsor

University Hospital, Gentofte, Copenhagen

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

•BMI 23-35

Primary endpoint

•Glucagon-like peptide-1 (GLP-1)

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 IDNCT02445508

Timeline

Milestones

Study first posted2015-05-15estimated

Last update posted2017-05-03actual

Study start2015-05 (month precision)

Primary completion2016-07actual (month precision)

Study completion2016-07actual (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age40 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes for at least 3 months (diagnosed according to the criteria of the World Health Organization (WHO))

•Men and postmenopausal women

•Metformin applied as the only anti-diabetic drug

•Caucasian ethnicity

•Normal haemoglobin

•Age above 40 years and below 70 years

•BMI >23 kg/m2 and <35 kg/m2

•Informed and written consent

Exclusion criteria

•Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder

•Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery

•Nephropathy (serum creatinine >150 µM and/or albuminuria)

•Hypo- and hyperthyroidism

•Hypo- and hypercalcaemia

•Hypo- and hyperphosphataemia

•Active or recent malignant disease

•Treatment with medicine that cannot be paused for 12 hours

•Treatment with oral anticoagulants

•Any treatment or condition requiring acute or sub-acute medical or surgical intervention

•Any condition considered incompatible with participation by the investigators

Endpoints (6)

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)

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Glucagon-like peptide-1 (GLP-1): Incremental and total area under the Concentration-Time Curve

Time frame:-30, -15, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 min on study days 1-4

concentration, descriptive

Secondary/protocol endpoint

Responses of various other gut hormones: Incremental and total area under the Concentration-Time Curve

Time frame:-30, -15, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 min on study days 1-4

concentration, descriptive

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Blood analysis of paracetamol as an assessment of gastric emptying

Time frame:-30, -15, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 min on study days 1-4

descriptive

Secondary/protocol endpoint/low confidence

Indirect calorimetry: Basal metabolic rate

Time frame:-30 min to 240 min

descriptive

Secondary/protocol endpoint/low confidence

Gallbladder volume as assessed by Ultrasound measurements

Time frame:-30 min to 240 min

descriptive

Secondary/protocol endpoint/low confidence

Appetite as assessed by Visual analog scale score

Time frame:-30 min to 240 min

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.