Clinical trial NCT00882050: Intravenous Exenatide (Byetta) During Surgery
Official title: Intravenous Exenatide (Byetta) for the Treatment of Perioperative Hyperglycemia: Rollover Phase I/II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Euglycemia
Hypoglycemia
Hyperglycemia
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Amylin Pharmaceuticals, LLC.
name: Eli Lilly and Company
First posted: 2009-04-16
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This is a single-center, block randomized, double-blind, placebo-controlled, dose-ranging study. Subjects will be randomized in equal proportions to one of three treatment arms: placebo of normal saline solution, 0.27 ng/kg/min (0.066 pmol/kg/min) IV Exenatide, and 0.41 ng/kg/min (0.099 pmol/kg/min) IV Exenatide. We will use a block number of 30 (please see power analysis) so that balance between each of the three groups will be maintained over the enrollment period. We will stratify the randomization scheme to ensure balance of diabetics and non-diabetics within the groups.

Eligibility criteria: 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

Primary outcomes:
measure: 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,
timeFrame: Baseline and 90 minutes after starting infusion;
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Benjamin A. Kohl, MD
role: STUDY_DIRECTOR
References: