GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT00782418

CompletedPhase 1Results posted

A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED)

A Randomized Clinical Trial to Study Glucose Dependent Insulin Secretion Methodologies in Healthy Lean Male Subjects

Lead sponsor

Merck Sharp & Dohme LLC

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI ≤26•Male

Primary endpoints

•Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose•C-peptide AUC•Insulin Concentration

Identifiers

Registered as

NCT IDNCT00782418

Org study ID0000-104

Secondary ID2008_568

Timeline

Milestones

Study first posted2008-10-31estimated

Results first posted2010-04-06estimated

Last update posted2016-12-21estimated

Study start2008-09 (month precision)

Primary completion2009-02actual (month precision)

Study completion2009-03actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Subject has a Body Mass Index (BMI) of less than or equal to 26 kg/m2 at screening

•Subject is judged to be in good health

•Subject has been a nonsmoker for at least 3 months

•Subject is willing to avoid strenuous physical activity for the duration of the study

Exclusion criteria

•Subject has a history of high blood pressure requiring treatment

•Subject has a history of diabetes or a family history of diabetes mellitus

•Subject is unable to discontinue all prescription and non-prescription drugs for duration of study

•Subject consumes more than 3 alcoholic beverages per day

•Subject consumes more than 6 servings of caffeinated beverages per day (1 serving = 120mg caffeine)

•Subject has had major surgery or has donated or loss 1 unit of blood within 4 weeks of screening

•Subject has multiple and/or severe allergies to foods or drugs

•Subject is a regular user of illegal drugs

•Subject is unwilling or unable to consume the standardized meals during the study and/or is on a carbohydrate restricted diet

Endpoints (3)

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.

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose

Time frame:Steady-state of HGC: 90 - 120 minutes post dose; highest glucose infusion rate of GGI: 120 - 160 minutes post dose

change from baseline, improvement

Posted result

Group	Value (geometric_mean), (ng/min) / (mg/dL)	95% CI
HGC - Exenatide 5 μg	2.14	1.52 – 2.52
HGC - Exenatide 1.5 μg	1.49	0.78 – 2.16
HGC - Placebo	0.53	0.19 – 0.73
GGI - Exenatide 5 μg	2.95	0.94 – 3.88
GGI - Exenatide 1.5 μg	2.07	0.82 – 3.30
GGI - Placebo	0.71	0.10 – 1.22

Least Squares Mean1.6090% CI1.29 – 1.92p<0.001ANOVA

Least Squares Mean0.9590% CI0.66 – 1.24p<0.001ANOVA

Least Squares Mean2.3290% CI1.57 – 3.06p<0.001ANOVA

Least Squares Mean1.3890% CI0.64 – 2.12p<0.001ANOVA

Primary/protocol endpoint

Change From Baseline in C-peptide Concentration

Time frame:Pre and Post glucose infusion

C-peptide AUC

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), ng/mL	95% CI
HGC - Exenatide 5 μg	29.3	25.2 – 35.1
HGC - Exenatide 1.5 μg	22.6	14.0 – 34.1
HGC - Placebo	6.24	2.3 – 8.9

Least Squares Mean23.190% CI19.2 – 27.0p<0.001ANOVA

Least Squares Mean16.490% CI12.6 – 20.1p<0.001ANOVA

Primary/protocol endpoint

Change From Baseline in Insulin Concentration

Time frame:Pre and Post glucose infusion

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), μIU(insulin)/mL	95% CI
HGC - Exenatide 5 μg	592	445 – 695
HGC - Exenatide 1.5 μg	293	128 – 597
HGC - Placebo	46.5	16.2 – 123

Least Squares Mean545.090% CI451.4 – 638.7p<0.001ANOVA

Least Squares Mean246.690% CI160.9 – 323.3p<0.001ANOVA

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Linearity of β-cell response across the metabolic spectrum and to pharmacology: insights from a graded glucose infusion-based investigation series.
American journal of physiology. Endocrinology and metabolism2016 Jun 1PMID27072496doi:10.1152/ajpendo.00527.2015via CT.gov reference + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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 1, 2026 snapshot.