Intravenous Exenatide (Byetta) During Surgery

This study is currently recruiting participants.
Verified June 2013 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: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Euglycemia
Hypoglycemia
Hyperglycemia
Drug: Exenatide
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Exenatide (Byetta) for the Treatment of Perioperative Hyperglycemia: Rollover Phase I/II Trial

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: March 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Exenatide to be infused by intravenous method at 0.27 ng/kg/min (0.066 pmol/kg/min)
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.
Active Comparator: 2
IV Exenatide to be infused by intravenous method at0.41 ng/kg/min (0.099 pmol/kg/min)
Drug: Exenatide
Exenatide to be infused intravenously 0.41 ng/kg/min (0.099 pmol/kg/min) for a duration of 3 to 6 hours
Placebo Comparator: 3
Placebo of normal saline solution
Drug: Placebo
Intravenous Placebo of normal saline solution to be infused at same rate as drug comparator

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882050

Contacts
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

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary S. Hammond, BSN    215-662-3772    mary.hammond@uphs.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
Study Director: Benjamin A. Kohl, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00882050     History of Changes
Other Study ID Numbers: 808104
Study First Received: April 15, 2009
Last Updated: June 18, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperglycemia
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014