Intravenous Exenatide (Byetta) During Surgery

NCTNCT00882050Other id808104

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Overview

Status: Completed
Phase: Phase 1/2
Enrollment: 104 participants (actual)
Sponsor: Thomas Jefferson University · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Mar 2009
Primary completion: Apr 2016
Completion: Apr 2016
First posted: 16 Apr 2009 (estimated)
Last update posted: 21 Jan 2022
Conditions: Euglycemia · Hypoglycemia · Hyperglycemia

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2010201220142016

Ph 1/2
Intravenous Exenatide (Byetta) During Surgery
NCT00882050
Mar 2009 to Apr 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this project is to study if intravenous Exenatide is effective at maintaining normal blood glucose levels and preventing low blood glucose levels during surgery.

Interventions

Exenatide 0.27 ng/kg/minDrug
Exenatide 0.41 ng/kg/minDrug
PlaceboDrug

Arms3

Experimental
Exentatide 0.27 ng/kg/min
Exenatide to be infused by intravenous method at 0.27 ng/kg/min (0.066 pmol/kg/min) over 3-6 hours. * Induction of anesthesia will be equal to Intubation time. Infusion will begin at this time point (+ or - 3 minutes). * Blood samples will be obtained prior to intubation and then 10 and 30 minutes after drug initiation and every 30 minutes (+ or - 2 minutes) thereafter until the infusion is stopped. The drug infusion will be stopped at extubation. Blood will then be sampled every 30 minutes (+ or - 2 minutes) post extubation for 2 hours, and once 24 hours after extubation. * Blood plasma levels will be collected (8-10 mls) for analysis of GLP-1, Glucose, Potassium, Insulin, Glucagon, Epinephrine, Norepinephrine, Cortisol, and free fatty acids (FFA).
Experimental
Exentatide 0.41 ng/kg/min
Experimental: IV Exenatide to be infused by intravenous method at 0.41 ng/kg/min (0.099 pmol/kg/min) over 3 to 6 hours. * Induction of anesthesia will be equal to Intubation time. Infusion will begin at this time point (+ or - 3 minutes). * Blood samples will be obtained prior to intubation and then 10 and 30 minutes after drug initiation and every 30 minutes (+ or - 2 minutes) thereafter until the infusion is stopped. The drug infusion will be stopped at extubation. Blood will then be sampled every 30 minutes (+ or - 2 minutes) post extubation for 2 hours, and once 24 hours after extubation. * Blood plasma levels will be collected (8-10 mls) for analysis of GLP-1, Glucose, Potassium, Insulin,Glucagon, Epinephrine, Norepinephrine, Cortisol, and free fatty acids (FFA).
Placebo comparator
Placebo IV NSS
Placebo of IV normal saline solution as comparator. * Induction of anesthesia will be equal to Intubation time. Infusion will begin at this time point (+ or - 3 minutes). * Blood samples will be obtained prior to intubation and then 10 and 30 minutes after drug initiation and every 30 minutes (+ or - 2 minutes) thereafter until the infusion is stopped. The drug infusion will be stopped at extubation. Blood will then be sampled every 30 minutes (+ or - 2 minutes) post extubation for 2 hours, and once 24 hours after extubation. * Blood plasma levels will be collected (8-10 mls) for analysis of GLP-1, Glucose, Potassium, Insulin, Glucagon, Epinephrine, Norepinephrine, Cortisol, and free fatty acids (FFA).

Primary outcomes1

Outcomes the sponsor listed as primary.

The Primary Objective is to Determine the Ability of Intravenous Exenatide to: Maintain Intraoperative Euglycemia in Subjects With Initial Blood Glucose < 126 mg/dL in Surgical Subjects as Compared to Placebo,
Time frame · Baseline and 90 minutes after starting infusion;
Registry description
Logistic regression analysis will be utizlized to determine maintenance of euglycemia (yes v no) for our primary analysis. A standard area under the curve (AUC) analysis will be performed for each time point to map out drug deposition. Assuming a standard 2 compartment model, 10 subjects per group is sufficient to accurately predict mean AUC. Our primary analysis should provide ample statistical power.

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· Baseline and 90 minutes after starting infusion;

The Primary Objective is to Determine the Ability of Intravenous Exenatide to: Maintain Intraoperative Euglycemia in Subjects With Initial Blood Glucose < 126 mg/dL in Surgical Subjects as Compared to Placebo,

Group	Value (mlg/dL)	Spread
Exentatide 0.27 ng/kg/Min	112.3	24.1
Exenatide 0.41ng/kg/Min	108.1	27.8
Placebo IV NSS	110.4	17.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Exentatide 0.27 ng/kg/MinExenatide to be infused by intravenous method at 0.27 ng/kg/min (0.066 pmol/kg/min) over 3-6 hours. Minimum 90 minutes post infusion.	0 / 32	0 / 32	2 / 32
Exenatide 0.41ng/kg/MinExenatide to be infused by intravenous method at 0.41 ng/kg/min (0.066 pmol/kg/min) over 3-6 hours. Minimum 90 minutes post infusion.	0 / 33	0 / 33	0 / 33
Placebo IV NSSPlacebo IV NSS to be at the rate of the experimental groups over 3-6 hours. Minimum 90 minutes post infusion.	0 / 39	0 / 39	0 / 39

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Age (\>18 years) * Weight of \> 50 kg and \< 150 kg * Ability to provide informed consent * Elective surgery including: * Cardiac surgery to include elective CABG with or without single or multivalve repair or replacement and/or single or multivalve repair/replacement requiring CPB and sternotomy (to include subjects who are undergoing first time or redo cardiac surgery) * Abdominal aortic aneurysm repair * Carotid endarterectomy * Esophagectomy * Cystectomy * Nephrectomy * If female, subject must be non-lactating, and, if of childbearing potential, must have a negative urine pregnancy test within 24 hours prior to receiving study drug Exclusion Criteria: * Age (\<18 years) * Inability to provide informed consent * History or risk of pancreatitis (e.g. ethanol abuse, gall stones) * Receipt of an investigational drug or device with 30 days prior to surgery * Use of any concomitant medication listed above on the day of surgery * Known allergy to Exenatide, fentanyl, midazolam, isoflurane, propofol, heparin or neuromuscular blockers * Known substance abuse * Surgical procedure other than: Cardiac surgery to include elective CABG with or without single or multivalve repair or replacement and/or single or multivalve repair/ replacement requiring CPB and sternotomy (to include subjects who are undergoing first time or redo cardiac surgery) * Abdominal aortic aneurysm repair * Carotid endarterectomy * Esophagectomy * Cystectomy * Nephrectomy * Insulin dependent diabetes mellitis * Anticipated administration of intraoperative steroids * Major end organ dysfunction, defined as: * Current intravenous inotropic agents * Preoperative use of intra-aortic balloon pump (IABP), left ventricular assist device (LVAD), or extracorporeal membrane oxygenation (ECMO) * Renal * Preoperative serum Creatinine \> 2.0 mg/dL * Hepatic * History of abnormal hepatic function in the past * Hematologic * Preoperative hematocrit (HCT) \< 30% * Platelet count \< 100,000/mm3 * History of bleeding or clotting disorder

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