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Intravenous Exenatide (Byetta) During Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00882050
First Posted: April 16, 2009
Last Update Posted: August 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Information provided by (Responsible Party):
University of Pennsylvania
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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; ]

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. ]

Enrollment: 12
Study Start Date: March 2009
Study Completion Date: April 2016
Primary Completion Date: April 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00882050


Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
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

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00882050     History of Changes
Other Study ID Numbers: 808104
First Submitted: April 15, 2009
First Posted: April 16, 2009
Last Update Posted: August 19, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Hypoglycemia
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists