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GLP-1 Receptor Agonist

Dulaglutide for Stress Hyperglycemia

Phase 4
Recruiting
Led By Georgia Davis, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women between the ages of 45 and 80 years undergoing non-cardiac general or vascular surgery with BMI ≥30 kg/m^2 without a previously known history of DM
Be older than 18 years old
Must not have
Patients undergoing cardiac surgery or patients anticipated to require ICU care
Treatment with oral (equivalent to prednisone > 5 mg/day) or injectable corticosteroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months after discharge
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will help determine if dulaglutide can prevent high blood sugar levels in people without diabetes who are having surgery.

Who is the study for?
This trial is for men and women aged 45-80, undergoing non-cardiac surgery with a BMI of ≥30 kg/m2, who don't have diabetes but may be at risk. It's not for those with mental conditions affecting consent, prisoners, certain gastrointestinal risks, on antihyperglycemic meds, history of specific cancers or endocrine disorders, severe kidney/liver issues, pregnant/breastfeeding individuals or those needing short hospital stays.
What is being tested?
The study tests if an injectable diabetes drug (dulaglutide) can prevent high blood sugar during surgery in patients without prior diabetes. Participants will also use a continuous glucose monitor (CGM), blinded to them. Some will receive dulaglutide while others get a placebo.
What are the potential side effects?
Dulaglutide could cause digestive problems like nausea or vomiting; it might also lead to inflammation of the pancreas or gallbladder disease. There's a small chance it could affect thyroid cancer risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 45-80 years old, have a BMI of 30 or more, and no known diabetes, planning to undergo surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am undergoing heart surgery or expected to need intensive care.
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I am taking steroids stronger than 5 mg of prednisone daily.
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I or my family have a history of medullary thyroid cancer or MEN2.
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My kidney function is severely impaired, or I have significant liver failure.
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I understand and can consent to the study on my own.
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I am at high risk for or expect to have major digestive system issues.
Select...
I am taking medication to lower my blood sugar.
Select...
I have issues with my stomach emptying, or have pancreatic or gallbladder disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months after discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months after discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of stress hyperglycemia (SH)
Percentage of time in target glucose range (70-140 mg/dL) by CGM
Secondary study objectives
Baseline Insulin Secretion
Baseline Insulin Sensitivity
Change in Adiponectin Level
+25 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: DulaglutideExperimental Treatment2 Interventions
Aim 2 participants randomized to receive dulaglutide within 72 hours prior to a planned surgery.
Group II: Continuous Glucose MonitoringExperimental Treatment1 Intervention
Aim 1 participants will have a continuous glucose monitor (CGM) placed preoperatively and will wear the CGM throughout hospitalization.
Group III: PlaceboPlacebo Group2 Interventions
Aim 2 participants randomized to receive a placebo to match dulaglutide within 72 hours prior to a planned surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dulaglutide
FDA approved

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,708 Previous Clinical Trials
2,607,404 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,842 Previous Clinical Trials
8,173,070 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,373 Total Patients Enrolled
Georgia Davis, MDPrincipal Investigator - Emory University
Northeast Georgia Medical Center - Gainesville
Emory University School Of Medicine (Medical School)
Emory University School Of Medicine (Residency)

Media Library

Dulaglutide (GLP-1 Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04862234 — Phase 4
Stress Hyperglycemia Research Study Groups: Continuous Glucose Monitoring, Placebo, Dulaglutide
Stress Hyperglycemia Clinical Trial 2023: Dulaglutide Highlights & Side Effects. Trial Name: NCT04862234 — Phase 4
Dulaglutide (GLP-1 Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04862234 — Phase 4
~7 spots leftby May 2025
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