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NCT00882050
Intravenous Exenatide (Byetta) for the Treatment of Perioperative Hyperglycemia: Rollover Phase I/II Trial
Phase 1/Phase 2 trial testing Exenatide 0.27 ng/kg/min in Euglycemia in 104 participants. Completed in 1 April 2016.
1 April 2016
Quick facts
| Lead sponsor | Thomas Jefferson University |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 104 |
| Start date | 1 March 2009 |
| Primary completion | 1 April 2016 |
| Estimated completion | 1 April 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Exenatide 0.27 ng/kg/min — full drug profile →
- Exenatide 0.41 ng/kg/min — full drug profile →
- Placebo
Conditions studied
- Euglycemia — all drugs for Euglycemia →
- Hypoglycemia — all drugs for Hypoglycemia →
- Hyperglycemia — all drugs for Hyperglycemia →
Sponsor
Thomas Jefferson University
Who can join
18 and older, any sex, with Euglycemia or Hypoglycemia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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 p
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00882050
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00882050 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Thomas Jefferson University
- Last refreshed: 21 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00882050.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing