Primary outcomeMean· baseline
Monocyte NfkB Levels as Detected by Western Blotting
| Group | Value (NfkB p65 arbitrary units) | Spread |
|---|---|---|
| Exenatide | 62.79 | 4.05 |
| Saxagliptin | 72.03 | 6.38 |
| Placebo | 67.68 | 6.38 |
| Exenatide Extended-release (ER) | 84.19 | 6.45 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataEffects of Antidiabetic Medications on the Postprandial State in Prediabetes
NCTNCT02104739 (opens ClinicalTrials.gov in a new tab)Other idHSC-MS-13-0791
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 21 participants (actual)
- Sponsor
- The University of Texas Health Science Center, Houston · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- Apr 2014
- Primary completion
- Mar 2017
- Completion
- Mar 2017
- First posted
- 4 Apr 2014 (estimated)
- Last update posted
- 3 Jul 2018
- Conditions
- Prediabetes · Obesity
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20142015201620172018
- Ph 4
Effects of Antidiabetic Medications on the Postprandial State in Prediabetes
NCT02104739Apr 2014 to Mar 2017
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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. These medications will be studied for their effect in reducing both postprandial lipid levels and arterial dysfunction.
Interventions
- ExenatideDrug
- SaxagliptinDrug
- Exenatide extended-release (ER)Drug
- PlaceboOther
Arms12
Experimental
Exenatide, then Saxagliptin, then Placebo
Exenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablets and Placebo (normal saline) injections
Experimental
Exenatide, then Placebo, then Saxagliptin
Exenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablets and Placebo (normal saline) injections
Placebo comparator
Saxagliptin, then Exenatide, then Placebo
Exenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablets and Placebo (normal saline) injections
Experimental
Saxagliptin, then Placebo, then Exenatide
Exenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablets and Placebo (normal saline) injections
Experimental
Placebo, then Exenatide, then Saxagliptin
Exenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablets and Placebo (normal saline) injections
Experimental
Placebo, then Saxagliptin, then Exenatide
Exenatide Single subcutaneous injection (10 mcg); Saxagliptin Single dose orally (5 mg); Placebo tablets and Placebo (normal saline) injections
Experimental
Exenatide, then Saxagliptin, then Placebo, then Exenatide ER
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
Experimental
Exenatide, then Placebo, then Saxagliptin, then Exenatide ER
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
Experimental
Saxagliptin, then Exenatide, then Placebo, then Exenatide ER
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
Experimental
Saxagliptin, then Placebo, then Exenatide, then Exenatide ER
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
Experimental
Placebo, then Exenatide, then Saxagliptin, then Exenatide ER
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
Experimental
Placebo, then Saxagliptin, then Exenatide, then Exenatide ER
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
Primary outcomes2
Outcomes the sponsor listed as primary.
Monocyte NfkB Levels as Detected by Western Blotting
Time frame · baseline
Registry description
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
Registry description
Monocyte NfkB p65 arbitrary units are quantified by densitometric analysis of the Western blots.
Secondary outcomes(11)
Triglycerides
Time frame · baseline
Registry description
triglycerides
Triglycerides
Time frame · 2 hours after ingestion of meal
Registry description
triglycerides
Triglycerides
Time frame · 4 hours after ingestion of meal
Registry description
triglycerides
Triglycerides
Time frame · 6 hours after ingestion of meal
Registry description
triglycerides
Free Fatty Acids
Time frame · baseline
Registry description
Free Fatty Acids
Free Fatty Acids
Time frame · 2 hours after meal
Registry description
Free Fatty Acids
Free Fatty Acids
Time frame · 4 hours after meal
Registry description
Free Fatty Acids
Free Fatty Acids
Time frame · 6 hours after meal
Registry description
Free Fatty Acids
Peak Forearm Blood Flow
Time frame · baseline
Registry description
Peak forearm blood flow via strain gauge venous occlusion plethysmography
Peak Forearm Blood Flow
Time frame · 3 hours after meal
Registry description
Peak forearm blood flow via strain gauge venous occlusion plethysmography
Peak Forearm Blood Flow
Time frame · 6 hours after meal
Registry description
Peak forearm blood flow via strain gauge venous occlusion plethysmography
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· 2 hours after ingestion of meal
Monocyte NfkB Levels as Detected by Western Blotting
| Group | Value (NfkB p65 arbitrary units) | Spread |
|---|---|---|
| Exenatide | 67.39 | 6.44 |
| Saxagliptin | 68.39 | 5.82 |
| Placebo | 71.37 | 5.82 |
| Exenatide Extended-release (ER) | 93.47 | 5.69 |
Secondary and other outcome results(6)
Secondary outcomeMean· baseline
Triglycerides
| Group | Value (milligrams per deciliter) | Spread |
|---|---|---|
| Exenatide | 108 | 11 |
| Saxagliptin | 101 | 11 |
| Placebo | 102 | 14 |
| Exenatide Extended-release (ER) | 106 | 14 |
Secondary outcomeMean· 2 hours after ingestion of meal
Triglycerides
| Group | Value (milligrams per deciliter) | Spread |
|---|---|---|
| Exenatide | 119 | 13 |
| Saxagliptin | 130 | 16 |
| Placebo | 163 | 19 |
| Exenatide Extended-release (ER) | 168 | 26 |
Secondary outcomeMean· 4 hours after ingestion of meal
Triglycerides
| Group | Value (milligrams per deciliter) | Spread |
|---|---|---|
| Exenatide | 124 | 12 |
| Saxagliptin | 153 | 24 |
| Placebo | 206 | 24 |
| Exenatide Extended-release (ER) | not posted | – |
Secondary outcomeMean· 6 hours after ingestion of meal
Triglycerides
| Group | Value (milligrams per deciliter) | Spread |
|---|---|---|
| Exenatide | 161 | 24 |
| Saxagliptin | 179 | 27 |
| Placebo | 200 | 22 |
| Exenatide Extended-release (ER) | not posted | – |
Secondary outcomeMean· baseline
Free Fatty Acids
| Group | Value (millimoles per liter) | Spread |
|---|---|---|
| Exenatide | 0.45 | 0.04 |
| Saxagliptin | 0.49 | 0.05 |
| Placebo | 0.51 | 0.04 |
| Exenatide Extended-release (ER) | 0.65 | 0.05 |
Secondary outcomeMean· 2 hours after meal
Free Fatty Acids
| Group | Value (millimoles per liter) | Spread |
|---|---|---|
| Exenatide | 0.35 | 0.05 |
| Saxagliptin | 0.18 | 0.02 |
| Placebo | 0.17 | 0.01 |
| Exenatide Extended-release (ER) | 0.19 | 0.05 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ExenatideExenatide: Single subcutaneous injection (10 mcg) | 0 / 16 | 0 / 16 | 0 / 16 |
| SaxagliptinSaxagliptin: Single dose orally (5 mg) | 0 / 16 | 0 / 16 | 0 / 16 |
| PlaceboPlacebo: Placebo tablets and Placebo (normal saline) injections | 0 / 16 | 0 / 16 | 0 / 16 |
| Exenatide Extended-release (ER)Exenatide extended-release (ER): Subcutaneous injection (2mg) weekly for 6 weeks | 0 / 7 | 0 / 7 | 0 / 7 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2020
11 results
Acute Exenatide Therapy Attenuates Postprandial Vasodilation in Humans with Prediabetes: A Randomized Controlled Trial.
Hamidi et al. 2020Metabolic syndrome and related disorderscited by 4
PMID 32228379PMC7262649DOI 10.1089/met.2019.0102PUB-32228379
Rights unknown11 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 30 Years up to 70 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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
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