PrediabetesPhase 4NCT02104739

Effects of Antidiabetic Medications on the Postprandial State in Prediabetes

A Phase 4 study testing Exenatide, Saxagliptin and Exenatide extended-release (ER) in people with Prediabetes and Obesity, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This project addresses cardiovascular disease risk in patients with prediabetes. Levels of lipids after eating a meal ("postprandial lipids") are strong independent predictors of cardiovascular risk. Newer anti-diabetic agents - exenatide and saxagliptin - impact lipid metabolism. Read more about this study

Who is it for?: Ages 30 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Prediabetes, Obesity
What is being tested?: Exenatide, Saxagliptin and Exenatide extended-release (ER)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Apr 2014to Mar 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

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

Read the detailed description

It is a paradox that medical efforts to control blood glucose in type 2 diabetes mellitus have not decreased the risk of cardiovascular disease. Postprandial lipid concentrations are a strong predictor of cardiovascular risk, independent of traditional cardiovascular risk factors. The new classes of antidiabetic medications - GLP-1 agonists and DPP-IV inhibitors - affect lipid as well as glucose metabolism. This study will investigate the efficacy of these medications in reducing postprandial hyperlipidemia, disrupting the concurrent proinflammatory free fatty acid signaling, and ameliorating endothelial dysfunction in individuals with prediabetes. This will consist of a single center, randomized, crossover, placebo-controlled double-blinded prospective trial involving three study arms representing the aforementioned medications: exenatide (GLP-1 agonist), saxagliptin (DPP-IV inhibitor), and placebo (control arm). Each subject will participate in each of the three arms, which are three separate, daylong outpatient studies. For each study arm, subjects will eat a standardized atherogenic high-fat test lunch. Venous blood draws and measurements of forearm blood flow will be done prior to the meal and periodically during a 6-hour period after the meal. Forearm blood flow measurements will assess for changes in endothelial function. The blood will be analyzed for multiple markers of hyperlipidemia and free fatty acid signaling. After completing the three randomized study visits, subjects are invited to participate in an optional, nonrandomized extension study. For the extension study, subjects will take exenatide ER (extended-release exenatide) weekly for total of six weeks. Then subjects return to eat a standardized atherogenic high-fat test lunch. Venous blood draws and measurements of forearm blood flow will be done prior to the meal and periodically during a 4-hour period after the meal, for the same analyses described before. The results will provide new insights into the anti-inflammatory effects of multiple antidiabetic medications via the mechanisms of postprandial hyperlipidemia, free fatty acid signaling, and endothelial function in prediabetic individuals.

Conditions: Prediabetes, Obesity
Being tested: Exenatide, Saxagliptin, Exenatide extended-release (ER), Placebo
Keywords: prediabetes, diabetes mellitus type 2, exenatide, saxagliptin, exenatide ER
Medical subject headings: Prediabetic State, Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ExenatideDrug
Also called Byetta
Single subcutaneous injection (10 mcg)
SaxagliptinDrug
Also called Onglyza
Single dose orally (5 mg)
Exenatide extended-release (ER)Drug
Also called Bydureon
Subcutaneous injection (2mg) weekly for 6 weeks
PlaceboOther
Placebo tablets and Placebo (normal saline) injections

Study groups in NCT02104739
Study group	Role	What they receive
Exenatide, then Saxagliptin, then Placebo	Experimental	Exenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablets and Placebo (normal saline) injections Receives: Drug: Exenatide; Drug: Saxagliptin; Other: Placebo
Exenatide, then Placebo, then Saxagliptin	Experimental	Exenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablets and Placebo (normal saline) injections Receives: Drug: Exenatide; Drug: Saxagliptin; Other: Placebo
Saxagliptin, then Exenatide, then Placebo	Placebo comparator	Exenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablets and Placebo (normal saline) injections Receives: Drug: Exenatide; Drug: Saxagliptin; Other: Placebo
Saxagliptin, then Placebo, then Exenatide	Experimental	Exenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablets and Placebo (normal saline) injections Receives: Drug: Exenatide; Drug: Saxagliptin; Other: Placebo
Placebo, then Exenatide, then Saxagliptin	Experimental	Exenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablets and Placebo (normal saline) injections Receives: Drug: Exenatide; Drug: Saxagliptin; Other: Placebo
Placebo, then Saxagliptin, then Exenatide	Experimental	Exenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablets and Placebo (normal saline) injections Receives: Drug: Exenatide; Drug: Saxagliptin; Other: Placebo
Exenatide, then Saxagliptin, then Placebo, then Exenatide ER	Experimental	Exenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablet and Placebo (normal saline) injection; Subcutaneous injection (2mg) weekly for 6 weeks Receives: Drug: Exenatide; Drug: Saxagliptin; Drug: Exenatide extended-release (ER); Other: Placebo
Exenatide, then Placebo, then Saxagliptin, then Exenatide ER	Experimental	Exenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablet and Placebo (normal saline) injection; Subcutaneous injection (2mg) weekly for 6 weeks Receives: Drug: Exenatide; Drug: Saxagliptin; Drug: Exenatide extended-release (ER); Other: Placebo
Saxagliptin, then Exenatide, then Placebo, then Exenatide ER	Experimental	Exenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablet and Placebo (normal saline) injection; Subcutaneous injection (2mg) weekly for 6 weeks Receives: Drug: Exenatide; Drug: Saxagliptin; Drug: Exenatide extended-release (ER); Other: Placebo
Saxagliptin, then Placebo, then Exenatide, then Exenatide ER	Experimental	Exenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablet and Placebo (normal saline) injection; Subcutaneous injection (2mg) weekly for 6 weeks Receives: Drug: Exenatide; Drug: Saxagliptin; Drug: Exenatide extended-release (ER); Other: Placebo
Placebo, then Exenatide, then Saxagliptin, then Exenatide ER	Experimental	Exenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablet and Placebo (normal saline) injection; Subcutaneous injection (2mg) weekly for 6 weeks Receives: Drug: Exenatide; Drug: Saxagliptin; Drug: Exenatide extended-release (ER); Other: Placebo
Placebo, then Saxagliptin, then Exenatide, then Exenatide ER	Experimental	Exenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablet and Placebo (normal saline) injection; Subcutaneous injection (2mg) weekly for 6 weeks Receives: Drug: Exenatide; Drug: Saxagliptin; Drug: Exenatide extended-release (ER); Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Monocyte NfkB Levels as Detected by Western Blotting
Monocyte NfkB p65 arbitrary units are quantified by densitometric analysis of the Western blots.
Measured: baseline
Monocyte NfkB Levels as Detected by Western Blotting
Monocyte NfkB p65 arbitrary units are quantified by densitometric analysis of the Western blots.
Measured: 2 hours after ingestion of meal

Secondary outcomes (11)

Triglycerides
triglycerides
Measured: baseline
Triglycerides
triglycerides
Measured: 2 hours after ingestion of meal
Triglycerides
triglycerides
Measured: 4 hours after ingestion of meal
Triglycerides
triglycerides
Measured: 6 hours after ingestion of meal
Free Fatty Acids
Free Fatty Acids
Measured: baseline
Free Fatty Acids
Free Fatty Acids
Measured: 2 hours after meal
Free Fatty Acids
Free Fatty Acids
Measured: 4 hours after meal
Free Fatty Acids
Free Fatty Acids
Measured: 6 hours after meal
Peak Forearm Blood Flow
Peak forearm blood flow via strain gauge venous occlusion plethysmography
Measured: baseline
Peak Forearm Blood Flow
Peak forearm blood flow via strain gauge venous occlusion plethysmography
Measured: 3 hours after meal
Peak Forearm Blood Flow
Peak forearm blood flow via strain gauge venous occlusion plethysmography
Measured: 6 hours after meal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Mar 2017

First posted4 Apr 2014 (estimated)
Study startApr 2014
Primary completionMar 2017
Study completionMar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PrediabetesStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02104739
Sponsor's protocol ID: HSC-MS-13-0791
Status last verified: Jun 2018
First submitted: 1 Apr 2014
Last updated: 3 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Hamidi V, Riggs K, Zhu L, Bermudez Saint Andre K, Westby C, Coverdale S, Dursteler A, Wang H, Miller Iii C, Taegtmeyer H, Gutierrez AD. Acute Exenatide Therapy Attenuates Postprandial Vasodilation in Humans with Prediabetes: A Randomized Controlled Trial. Metab Syndr Relat Disord. 2020 Jun;18(5):225-233. doi: 10.1089/met.2019.0102. Epub 2020 Mar 31.
PubMed 32228379

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Effects of Antidiabetic Medications on Postprandial Hyperlipidemia, Free Fatty Acid Signaling, and Endothelial Dysfunction in Individuals With Prediabetes
ClinicalTrials.gov ID: NCT02104739
Acronym / sponsor ID: HSC-MS-13-0791
Conditions: Prediabetes, Obesity
Keywords: prediabetes, diabetes mellitus type 2, exenatide, saxagliptin, exenatide ER
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
Study start: Apr 2014 (actual)
Primary completion: Mar 2017 (actual)
Study completion: Mar 2017 (actual)
First posted: 4 Apr 2014 (estimated)
Results: Posted 3 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 12

Arm	Type	Receives
Exenatide, then Saxagliptin, then Placebo	Experimental	Drug: Exenatide, Drug: Saxagliptin, Other: PlaceboExenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablets and Placebo (normal saline) injections
Exenatide, then Placebo, then Saxagliptin	Experimental	Drug: Exenatide, Drug: Saxagliptin, Other: PlaceboExenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablets and Placebo (normal saline) injections
Saxagliptin, then Exenatide, then Placebo	Placebo comparator	Drug: Exenatide, Drug: Saxagliptin, Other: PlaceboExenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablets and Placebo (normal saline) injections
Saxagliptin, then Placebo, then Exenatide	Experimental	Drug: Exenatide, Drug: Saxagliptin, Other: PlaceboExenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablets and Placebo (normal saline) injections
Placebo, then Exenatide, then Saxagliptin	Experimental	Drug: Exenatide, Drug: Saxagliptin, Other: PlaceboExenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablets and Placebo (normal saline) injections
Placebo, then Saxagliptin, then Exenatide	Experimental	Drug: Exenatide, Drug: Saxagliptin, Other: PlaceboExenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablets and Placebo (normal saline) injections
Exenatide, then Saxagliptin, then Placebo, then Exenatide ER	Experimental	Drug: Exenatide, Drug: Saxagliptin, Drug: Exenatide extended-release (ER), Other: PlaceboExenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablet and Placebo (normal saline) injection; Subcutaneous injection (2mg) weekly for 6 weeks
Exenatide, then Placebo, then Saxagliptin, then Exenatide ER	Experimental	Drug: Exenatide, Drug: Saxagliptin, Drug: Exenatide extended-release (ER), Other: PlaceboExenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablet and Placebo (normal saline) injection; Subcutaneous injection (2mg) weekly for 6 weeks
Saxagliptin, then Exenatide, then Placebo, then Exenatide ER	Experimental	Drug: Exenatide, Drug: Saxagliptin, Drug: Exenatide extended-release (ER), Other: PlaceboExenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablet and Placebo (normal saline) injection; Subcutaneous injection (2mg) weekly for 6 weeks
Saxagliptin, then Placebo, then Exenatide, then Exenatide ER	Experimental	Drug: Exenatide, Drug: Saxagliptin, Drug: Exenatide extended-release (ER), Other: PlaceboExenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablet and Placebo (normal saline) injection; Subcutaneous injection (2mg) weekly for 6 weeks
Placebo, then Exenatide, then Saxagliptin, then Exenatide ER	Experimental	Drug: Exenatide, Drug: Saxagliptin, Drug: Exenatide extended-release (ER), Other: PlaceboExenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablet and Placebo (normal saline) injection; Subcutaneous injection (2mg) weekly for 6 weeks
Placebo, then Saxagliptin, then Exenatide, then Exenatide ER	Experimental	Drug: Exenatide, Drug: Saxagliptin, Drug: Exenatide extended-release (ER), Other: PlaceboExenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablet and Placebo (normal saline) injection; Subcutaneous injection (2mg) weekly for 6 weeks

Who may qualify

Ages: 30 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (18 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ExenatideAlso: ByettaSingle subcutaneous injection (10 mcg)	Drug	Exenatide, then Placebo, then Saxagliptin, Exenatide, then Placebo, then Saxagliptin, then Exenatide ER, Exenatide, then Saxagliptin, then Placebo, Exenatide, then Saxagliptin, then Placebo, then Exenatide ER, Placebo, then Exenatide, then Saxagliptin, Placebo, then Exenatide, then Saxagliptin, then Exenatide ER, Placebo, then Saxagliptin, then Exenatide, Placebo, then Saxagliptin, then Exenatide, then Exenatide ER, Saxagliptin, then Exenatide, then Placebo, Saxagliptin, then Exenatide, then Placebo, then Exenatide ER, Saxagliptin, then Placebo, then Exenatide, Saxagliptin, then Placebo, then Exenatide, then Exenatide ER
SaxagliptinAlso: OnglyzaSingle dose orally (5 mg)	Drug	Exenatide, then Placebo, then Saxagliptin, Exenatide, then Placebo, then Saxagliptin, then Exenatide ER, Exenatide, then Saxagliptin, then Placebo, Exenatide, then Saxagliptin, then Placebo, then Exenatide ER, Placebo, then Exenatide, then Saxagliptin, Placebo, then Exenatide, then Saxagliptin, then Exenatide ER, Placebo, then Saxagliptin, then Exenatide, Placebo, then Saxagliptin, then Exenatide, then Exenatide ER, Saxagliptin, then Exenatide, then Placebo, Saxagliptin, then Exenatide, then Placebo, then Exenatide ER, Saxagliptin, then Placebo, then Exenatide, Saxagliptin, then Placebo, then Exenatide, then Exenatide ER
Exenatide extended-release (ER)Also: BydureonSubcutaneous injection (2mg) weekly for 6 weeks	Drug	Exenatide, then Placebo, then Saxagliptin, then Exenatide ER, Exenatide, then Saxagliptin, then Placebo, then Exenatide ER, Placebo, then Exenatide, then Saxagliptin, then Exenatide ER, Placebo, then Saxagliptin, then Exenatide, then Exenatide ER, Saxagliptin, then Exenatide, then Placebo, then Exenatide ER, Saxagliptin, then Placebo, then Exenatide, then Exenatide ER
PlaceboPlacebo tablets and Placebo (normal saline) injections	Other	Exenatide, then Placebo, then Saxagliptin, Exenatide, then Placebo, then Saxagliptin, then Exenatide ER, Exenatide, then Saxagliptin, then Placebo, Exenatide, then Saxagliptin, then Placebo, then Exenatide ER, Placebo, then Exenatide, then Saxagliptin, Placebo, then Exenatide, then Saxagliptin, then Exenatide ER, Placebo, then Saxagliptin, then Exenatide, Placebo, then Saxagliptin, then Exenatide, then Exenatide ER, Saxagliptin, then Exenatide, then Placebo, Saxagliptin, then Exenatide, then Placebo, then Exenatide ER, Saxagliptin, then Placebo, then Exenatide, Saxagliptin, then Placebo, then Exenatide, then Exenatide ER

Primary outcome

Monocyte NfkB Levels as Detected by Western Blotting
Time frame: baseline
Monocyte NfkB p65 arbitrary units are quantified by densitometric analysis of the Western blots.
Monocyte NfkB Levels as Detected by Western Blotting
Time frame: 2 hours after ingestion of meal
Monocyte NfkB p65 arbitrary units are quantified by densitometric analysis of the Western blots.

11 secondary outcomes

Triglycerides
Time frame: baseline
Triglycerides
Time frame: 2 hours after ingestion of meal
Triglycerides
Time frame: 4 hours after ingestion of meal
Triglycerides
Time frame: 6 hours after ingestion of meal
Free Fatty Acids
Time frame: baseline
Free Fatty Acids
Time frame: 2 hours after meal
Free Fatty Acids
Time frame: 4 hours after meal
Free Fatty Acids
Time frame: 6 hours after meal
Peak Forearm Blood Flow
Time frame: baseline
Peak Forearm Blood Flow
Time frame: 3 hours after meal
Peak Forearm Blood Flow
Time frame: 6 hours after meal

Results and safety

Results posted to the registry on 3 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exenatide, Then Saxagliptin, Then Placebo	2	2
Exenatide, Then Placebo, Then Saxagliptin	5	4
Saxagliptin, Then Exenatide, Then Placebo	2	2
Saxagliptin, Then Placebo, Then Exenatide	8	7
Placebo, Then Exenatide, Then Saxagliptin	0	0
Placebo, Then Saxagliptin, Then Exenatide	3	3
Exenatide Extended-release (Extension Phase)	0	0

Primary outcome: Monocyte NfkB Levels as Detected by Western Blotting

Time frame: baseline. Mean (Standard Error). Unit: NfkB p65 arbitrary units

Measure	Exenatide n = 16	Saxagliptin n = 16	Placebo n = 16	Exenatide Extended-release (ER) n = 7
Value	62.79 (4.05)	72.03 (6.38)	67.68 (6.38)	84.19 (6.45)

Primary outcome: Monocyte NfkB Levels as Detected by Western Blotting

Time frame: 2 hours after ingestion of meal. Mean (Standard Error). Unit: NfkB p65 arbitrary units

Measure	Exenatide n = 16	Saxagliptin n = 16	Placebo n = 16	Exenatide Extended-release (ER) n = 7
Value	67.39 (6.44)	68.39 (5.82)	71.37 (5.82)	93.47 (5.69)

Exenatide: p = 0.27, Non-parametric Wilcoxon paired rank sum
Saxagliptin: p = 0.59, Non-parametric Wilcoxon paired rank sum
Placebo: p = 0.51, Non-parametric Wilcoxon paired rank sum

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Subjects were followed during the study and for 30 days following the last dose. During the cross-over study, subjects were followed for a min of 53 days to a max of 150 days after taking the 1st dose [(3 days for 3, 1-day study arms) + (20 days to 117 days total for 2 washout periods) + 30 = 53 days]. (Washout was at least 20 days but could be 117 days since the cross-over study could span 120 days.) During the extension study, subjects were followed for 72 days after taking the 1st dose.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exenatide	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Saxagliptin	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Placebo	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Exenatide Extended-release (ER)	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Limitations and caveats (from the sponsor): Lower than expected sample size.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32228379Hamidi V, Riggs K, Zhu L, Bermudez Saint Andre K, Westby C, Coverdale S, Dursteler A, Wang H, Miller Iii C, Taegtmeyer H, Gutierrez AD. Acute Exenatide Therapy Attenuates Postprandial Vasodilation in Humans with Prediabetes: A Randomized Controlled Trial. Metab Syndr Relat Disord. 2020 Jun;18(5):225-233. doi: 10.1089/met.2019.0102. Epub 2020 Mar 31.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Absalaon D Gutierrez, MD principal investigator

University of Texas Health Science Center at Houston, Dept. of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Monocyte NfkB Levels as Detected by Western Blotting (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02104739, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.