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

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:

MedlinePlus related topics: Blood Sugar Hyperglycemia Hypoglycemia

Drug Information available for: Exenatide

U.S. FDA Resources

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 2012
Estimated Primary Completion Date:	December 2012 (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 3-6 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:	September 12, 2012
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 May 16, 2013

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