Text Size

Intravenous Exenatide (Byetta) During Surgery

This study is currently recruiting participants.
Verified September 2012 by University of Pennsylvania
Sponsor:
Collaborators:
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00882050
First received: April 15, 2009
Last updated: September 12, 2012
Last verified: September 2012
History of Changes

April 15, 2009
September 12, 2012
March 2009
December 2012   (final data collection date for primary outcome 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, [ Time Frame: at 90 minutes after starting infusion; ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00882050 on ClinicalTrials.gov Archive Site
establish intraoperative euglycemia in surgical subjects with initial blood glucose greater than 126 mg/dL in subjects as compared to placebo [ Time Frame: at 90 minutes after starting infusion. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Intravenous Exenatide (Byetta) During Surgery
Intravenous Exenatide (Byetta) for the Treatment of Perioperative Hyperglycemia: Rollover Phase I/II Trial

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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Euglycemia
  • Hypoglycemia
  • Hyperglycemia
  • Drug: Exenatide
    Exenatide to be infused intravenously at 0.27 ng/kg/min (0.066 pmol/kg/min) for a duration of 3 to 6 hours.
  • Drug: Exenatide
    Exenatide to be infused intravenously 0.41 ng/kg/min (0.099 pmol/kg/min) for a duration of 3-6 hours
  • Drug: Placebo
    Intravenous Placebo of normal saline solution to be infused at same rate as drug comparator
  • Active Comparator: 1
    Exenatide to be infused by intravenous method at 0.27 ng/kg/min (0.066 pmol/kg/min)
    Intervention: Drug: Exenatide
  • Active Comparator: 2
    IV Exenatide to be infused by intravenous method at0.41 ng/kg/min (0.099 pmol/kg/min)
    Intervention: Drug: Exenatide
  • Placebo Comparator: 3
    Placebo of normal saline solution
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mary S. Hammond, BSN 215-662-3772 mary.hammond@uphs.upenn.edu
Contact: Benjamin A. Kohl, MD 215-662-4000 benjamin.kohl@uphs.upenn.edu
United States
 
NCT00882050
808104
Yes
University of Pennsylvania
University of Pennsylvania
  • Amylin Pharmaceuticals, LLC.
  • Eli Lilly and Company
Study Director: Benjamin A. Kohl, MD University of Pennsylvania
University of Pennsylvania
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP