Phase 2
Completed N=104
Intravenous Exenatide (Byetta) During Surgery
Euglycemia · Hypoglycemia · Hyperglycemia
Source: ClinicalTrials.gov NCT00882050 ↗
Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcomePrimary: 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
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.
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 |
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. Informational only — not medical advice.