- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00882050
Intravenous Exenatide (Byetta) During Surgery
Intravenous Exenatide (Byetta) for the Treatment of Perioperative Hyperglycemia: Rollover Phase I/II Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exentatide 0.27 ng/kg/min
Exenatide to be infused by intravenous method at 0.27 ng/kg/min (0.066 pmol/kg/min) over 3-6 hours.
|
Exenatide to be infused intravenously at 0.27 ng/kg/min (0.066 pmol/kg/min) for a duration of 3 to 6 hours.
Other Names:
|
Experimental: Exentatide 0.41 ng/kg/min
Experimental: IV Exenatide to be infused by intravenous method at 0.41 ng/kg/min (0.099 pmol/kg/min) over 3 to 6 hours.
|
Exenatide to be infused intravenously 0.41 ng/kg/min (0.099 pmol/kg/min) for a duration of 3 to 6 hours Induction of anesthesia will be equal to Intubation time. Infusion will begin at this time point (+ or - 3 minutes).
Other Names:
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Placebo Comparator: Placebo IV NSS
Placebo of IV normal saline solution as comparator.
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Intravenous Placebo of NSS infused at same rate as drug comparator. Induction of anesthesia will be equal to Intubation time. Infusion will begin at this time point (+ or - 3 minutes).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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: Baseline and 90 minutes after starting infusion;
|
Logistic regression analysis will be utizlized to determine maintenance of euglycemia (yes v no) for our primary analysis.
A standard area under the curve (AUC) analysis will be performed for each time point to map out drug deposition.
Assuming a standard 2 compartment model, 10 subjects per group is sufficient to accurately predict mean AUC.
Our primary analysis should provide ample statistical power.
|
Baseline and 90 minutes after starting infusion;
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Benjamin A. Kohl, MD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 808104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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