GLP-1 Peptide Atlas, by Delfa

CompletedPhase 4Results posted

Effects of Antidiabetic Medications on the Postprandial State in Prediabetes

Comparative Effects of Antidiabetic Medications on Postprandial Hyperlipidemia, Free Fatty Acid Signaling, and Endothelial Dysfunction in Individuals With Prediabetes

Lead sponsor

The University of Texas Health Science Center, Houston

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Prediabetes / glucose intolerance

Key I/E criteria

•BMI 30-35•HbA1c 5.7-6.4%

Primary endpoints

•Monocyte NfkB Levels as Detected by Western Blotting•Monocyte nfkb western blot

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02104739

Org study IDHSC-MS-13-0791

Timeline

Milestones

Study first posted2014-04-04estimated

Last update posted2018-07-03actual

Results first posted2018-07-03actual

Study start2014-04actual (month precision)

Primary completion2017-03actual (month precision)

Study completion2017-03actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age30 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Diagnosis of Prediabetes - defined as either impaired fasting glucose (fasting glucose of 100-125 mg/dL), impaired glucose tolerance (2-hour postprandial blood glucose of 140-199 mg/dL after 75 gram oral glucose challenge), and/or a hemoglobin A1C ranging from 5.7% to 6.4%

•Subjects are allowed, but not required, to be on statins, ACE-inhibitors, beta-blockers, angiotensin-receptor blockers, thiazide diuretics, and/or loop diuretics at doses that have been stable for at least the last 3 months

•BMI between 30-35 kg/m2 (±1 kg/m2)

•Body weight has been stable (±4-5 pounds) over the prior three months.

•Women of childbearing age must agree to use an acceptable method of pregnancy prevention (barrier methods, abstinence, or surgical sterilization) for the duration of the study

•Patients must have the following laboratory values: Hematocrit ≥ 34 vol% S. creatinine < 1.5 mg/dl in men and 1.4 mg/dl in women AST (SGOT) < 2.5 times ULN, ALT (SGPT) < 2.5 times ULN, alkaline phosphatase< 2.5 times ULN

Exclusion criteria

•History of Type 1 or Type 2 diabetes mellitus

•History of diabetic ketoacidosis or hyperosmolar nonketotic coma

•Pregnant or breastfeeding women

•Patients must not be receiving lipid-lowering medications other than statins within the last 3 months

•Patient must not be receiving metformin, DPP-IV inhibitors, GLP-1 agonists, thiazolidinediones, insulin, sulfonylureas, acarbose, SGLT-2 inhibitors, corticosteroids, or immunosuppressive therapy within the last 3 months and cannot take them for the duration of the study. Patient must not be receiving NSAIDS or antioxidant vitamins within the last 1 week, and cannot take them for the duration of the study.

•Patients must not be on hormone replacement therapy.

•Patients with diabetic gastroparesis

•Patients with current tobacco use

•Patients with active malignancy

•Patients with history of urinary bladder cancer

•Patients with dietary restrictions precluding a high-fat meal

•Patients with a history of clinically significant heart disease (NYHA III or IV; more than non- specific ST-T wave changes on the EKG), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) will not be studied

•Subjects with a history of any serious hypersensitivity reaction to the study medications

•Prisoners or subjects who are involuntarily incarcerated

•Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness

•Subjects with known allergic reactions to the study medications or test meal

•Subjects unwilling or unable to provide informed consent

•Subjects determined by the investigator(s) to not be appropriate candidates for the study

Endpoints (13)

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

Cardiometabolic biomarkers

Cardiovascular outcomes

3 endpoints

Secondary/protocol endpoint

Peak Forearm Blood Flow

Time frame:baseline

forearm blood flow peak

descriptive

Posted result

Group	Value (mean), mL per minute per 100mL of tissue	95% CI
Exenatide	12.65	—
Saxagliptin	12.79	—
Placebo	12.18	—
Exenatide Extended-release (ER)	16.18	—

Secondary/protocol endpoint

Peak Forearm Blood Flow

Time frame:3 hours after meal

peak FBF

change from baseline, improvement

Posted result

Group	Value (mean), mL per minute per 100mL of tissue	95% CI
Exenatide	13.18	—
Saxagliptin	13.25	—
Placebo	15.11	—
Exenatide Extended-release (ER)	16.54	—

p0.5ANOVA

Secondary/protocol endpoint

Peak Forearm Blood Flow

Time frame:6 hours after meal

concentration, improvement

Posted result

Group	Value (mean), mL per minute per 100mL of tissue	95% CI
Exenatide	14.25	—
Saxagliptin	15.87	—
Placebo	13.45	—

p>0.05ANOVA

The reported p-value compares exenatide and saxagliptin over all time points (3 hours, 6 hours).

p>0.05ANOVA

The reported p-value compares exenatide and placebo over all time points (3 hours, 6 hours).

Cardiometabolic biomarkers

10 endpoints

Primary/protocol endpoint

Monocyte NfkB Levels as Detected by Western Blotting

Time frame:baseline

change from baseline, improvement

Posted result

Group	Value (mean), NfkB p65 arbitrary units	95% CI
Exenatide	62.79	—
Saxagliptin	72.03	—
Placebo	67.68	—
Exenatide Extended-release (ER)	84.19	—

Primary/protocol endpoint

Monocyte NfkB Levels as Detected by Western Blotting

Time frame:2 hours after ingestion of meal

monocyte nfkb western blot

change from baseline, improvement

Posted result

Group	Value (mean), NfkB p65 arbitrary units	95% CI
Exenatide	67.39	—
Saxagliptin	68.39	—
Placebo	71.37	—
Exenatide Extended-release (ER)	93.47	—

p0.27Non-parametric Wilcoxon paired rank sum

Exenatide at baseline and 2 hours after ingestion of meal is compared.

p0.59Non-parametric Wilcoxon paired rank sum

Saxagliptin at baseline and 2 hours after ingestion of meal is compared.

p0.51Non-parametric Wilcoxon paired rank sum

Placebo at baseline and 2 hours after ingestion of meal is compared.

p0.31Non-parametric Wilcoxon paired rank sum

Exenatide extended-release (ER) at baseline and 2 hours after ingestion of meal is compared.

Secondary/protocol endpoint

Triglycerides

Time frame:baseline

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (mean), milligrams per deciliter	95% CI
Exenatide	108	—
Saxagliptin	101	—
Placebo	102	—
Exenatide Extended-release (ER)	106	—

Secondary/protocol endpoint

Triglycerides

Time frame:2 hours after ingestion of meal

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (mean), milligrams per deciliter	95% CI
Exenatide	119	—
Saxagliptin	130	—
Placebo	163	—
Exenatide Extended-release (ER)	168	—

p0.02ANOVA

Secondary/protocol endpoint

Triglycerides

Time frame:4 hours after ingestion of meal

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (mean), milligrams per deciliter	95% CI
Exenatide	124	—
Saxagliptin	153	—
Placebo	206	—

Secondary/protocol endpoint

Triglycerides

Time frame:6 hours after ingestion of meal

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (mean), milligrams per deciliter	95% CI
Exenatide	161	—
Saxagliptin	179	—
Placebo	200	—

p<0.05ANOVA

The reported p-value compares exenatide and saxagliptin over all time points (2 hours, 4 hours, 6 hours).

p<0.05ANOVA

The reported p-value compares exenatide and placebo over all time points (2 hours, 4 hours, 6 hours).

Secondary/protocol endpoint

Free Fatty Acids

Time frame:baseline

Free fatty acids, change

change from baseline, improvement

Posted result

Group	Value (mean), millimoles per liter	95% CI
Exenatide	0.45	—
Saxagliptin	0.49	—
Placebo	0.51	—
Exenatide Extended-release (ER)	0.65	—

Secondary/protocol endpoint

Free Fatty Acids

Time frame:2 hours after meal

Free fatty acids, change

change from baseline, improvement

Posted result

Group	Value (mean), millimoles per liter	95% CI
Exenatide	0.35	—
Saxagliptin	0.18	—
Placebo	0.17	—
Exenatide Extended-release (ER)	0.19	—

p0.018ANOVA

Secondary/protocol endpoint

Free Fatty Acids

Time frame:4 hours after meal

Free fatty acids, change

change from baseline, improvement

Posted result

Group	Value (mean), millimoles per liter	95% CI
Exenatide	0.43	—
Saxagliptin	0.24	—
Placebo	0.23	—

Secondary/protocol endpoint

Free Fatty Acids

Time frame:6 hours after meal

Free fatty acids, change

change from baseline, improvement

Posted result

Group	Value (mean), millimoles per liter	95% CI
Exenatide	0.29	—
Saxagliptin	0.31	—
Placebo	0.33	—

p<0.05ANOVA

The reported p-value compares exenatide and saxagliptin over all time points (2 hours, 4 hours, 6 hours).

p<0.05ANOVA

The reported p-value compares exenatide and placebo over all time points (2 hours, 4 hours, 6 hours).

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

Acute Exenatide Therapy Attenuates Postprandial Vasodilation in Humans with Prediabetes: A Randomized Controlled Trial.
Metabolic syndrome and related disorders2020 Jun (month)PMID32228379doi:10.1089/met.2019.0102via clinicaltrials gov reference derived + 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.