Phase 2
N=104
Intravenous Exenatide (Byetta) During Surgery
Euglycemia · Hypoglycemia · Hyperglycemia
Bottom Line
View on ClinicalTrials.gov: NCT00882050 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: 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, — 112.3; 108.1; 110.4; 120.3 mlg/dL — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Exenatide 0.27 ng/kg/min (Drug); Exenatide 0.41 ng/kg/min (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Jefferson University
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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, |
112.3; 108.1; 110.4; 120.3; 125.0; 120.8 | 0.05 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age (>18 years)
- Weight of > 50 kg and 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
Data sourced from ClinicalTrials.gov (NCT00882050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.