NCT04862234

Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients

Terminated Phase 4 Results posted Last updated 17 January 2025

What this trial tests

Phase 4 trial testing Dulaglutide in Hyperglycemia Stress in 16 participants. Terminated before completion.

Timeline

6 August 2021

Primary endpoint
22 June 2023

22 June 2023

Quick facts

Lead sponsor	Emory University
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	16
Start date	6 August 2021
Primary completion	22 June 2023
Estimated completion	22 June 2023
Sites	2 locations across United States

Drugs / interventions tested

• Dulaglutide (DULAGLUTIDE) — full drug profile →
• Placebo
• Continuous glucose monitor (CGM), blinded

Conditions studied

• Hyperglycemia Stress — all drugs for Hyperglycemia Stress →

Sponsor

Emory University

Who can join

Adults 45 to 80, any sex, with Hyperglycemia Stress. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Time in Target Glucose Range (70-140 mg/dL) by CGM Primary · During hospitalization (up to 5 days postoperatively)

The percentage of time in the target glucose range of 70-140 mg/dL, as measured by a continuous glucose monitor (CGM) data was determined.

Group	Value	95% CI
Dulaglutide	84.19	± 19.70
Placebo	71.82	± 27.26

Adverse events — posted to ClinicalTrials.gov

Time frame: Information on adverse events was collected from the time that individuals gave consent to participate in the study through the final assessment at hospital discharge, up to 5 days postoperatively.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dulaglutide

Serious: 1/8 (13%)

Deaths: 0/8

Placebo

Serious: 0/8 (0%)

Deaths: 0/8

Serious adverse events (1 terms)

Reaction	System	Dulaglutide	Placebo
Prolonged hospital length of stay due to tachycardia	Cardiac disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Dulaglutide	Placebo
Nausea, vomiting, constipation	Gastrointestinal disorders	—	—
Hypoglycemia, prior to study medication administration	Endocrine disorders	—	—
Tachycardia	Cardiac disorders	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Prolonged hospital length of stay due to tachycardia.

Data from ClinicalTrials.gov NCT04862234 adverse events section.

Sponsor's own description

Hyperglycemia is seen in approximately 30% of patients who do not have a history of diabetes and undergo general surgery. Hyperglycemia in this setting is associated with increased risk of postoperative complications. The purpose of this study is to investigate risk factors for developing high sugars during the time of surgery, and if these high sugars can be prevented by the use of an injectable diabetes medication (dulaglutide) prior to surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.