Intravenous Exenatide (Byetta) During Surgery

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
EuglycemiaHypoglycemiaHyperglycemia
Interventions
DRUG

Exenatide 0.27 ng/kg/min

"Exenatide to be infused intravenously at 0.27 ng/kg/min (0.066 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).~* Blood samples will be obtained prior to intubation and then 10 and 30 minutes after drug initiation and every 30 minutes (+ or - 2 minutes) thereafter until the infusion is stopped. The drug infusion will be stopped at extubation. Blood will then be sampled every 30 minutes (+ or - 2 minutes) post extubation for 2 hours, and once 24 hours after extubation.~* Blood plasma levels will be collected (8-10 mls) for analysis of GLP-1, Glucose, Potassium, Insulin, Glucagon, Epinephrine, Norepinephrine, Cortisol, and free fatty acids (FFA)."

DRUG

Exenatide 0.41 ng/kg/min

"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).~* Blood samples will be obtained prior to intubation and then 10 and 30 minutes after drug initiation and every 30 minutes (+ or - 2 minutes) thereafter until the infusion is stopped. The drug infusion will be stopped at extubation. Blood will then be sampled every 30 minutes (+ or - 2 minutes) post extubation for 2 hours, and once 24 hours after extubation.~* Blood plasma levels will be collected (8-10 mls) for analysis of GLP-1, Glucose, Potassium, Insulin, Glucagon, Epinephrine, Norepinephrine, Cortisol, and free fatty acids (FFA)."

DRUG

Placebo

"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).~* Blood samples will be obtained prior to intubation and then 10 and 30 minutes after drug initiation and every 30 minutes (+ or - 2 minutes) thereafter until the infusion is stopped. The drug infusion will be stopped at extubation. Blood will then be sampled every 30 minutes (+ or - 2 minutes) post extubation for 2 hours, and once 24 hours after extubation.~* Blood plasma levels will be collected (8-10 mls) for analysis of GLP-1, Glucose, Potassium, Insulin, Glucagon, Epinephrine, Norepinephrine, Cortisol, and free fatty acids (FFA)."

Trial Locations (1)

19104

University of Pennsylvania, Philadelphia

Sponsors
All Listed Sponsors
collaborator

Amylin Pharmaceuticals, LLC.

INDUSTRY

collaborator

Eli Lilly and Company

INDUSTRY

lead

Thomas Jefferson University

OTHER

NCT00882050 - Intravenous Exenatide (Byetta) During Surgery | Biotech Hunter | Biotech Hunter