Dulaglutide Injection for Stress Hyperglycemia

Grady Memorial Hospital, Atlanta, GA
Stress HyperglycemiaDulaglutide Injection - Drug
Eligibility
40 - 80
All Sexes
What conditions do you have?
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Study Summary

This trial will study whether dulaglutide can help prevent stress-hyperglycemia and the metabolic inflammatory response during surgery.

Eligible Conditions
  • Stress Hyperglycemia

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

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Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 7 days postoperatively

Day 5
Mean blood glucose levels in mg/dL during the Intensive Care Unit (ICU) stay post operatively between patients randomized to dulaglutide or placebo arms
Day 7
Frequency of rescue therapy with subcutaneous insulin after transition to regular floor post operatively between patients randomized to dulaglutide or placebo arms
Mean blood glucose levels in mg/dL during the hospital stay post operatively between patients randomized to dulaglutide or placebo arms
Day 7
Frequency of Blood Glucose levels (BG) > 140 mg/dl during post operative period between patients randomized to dulaglutide or placebo arms

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Complete Metabolic Panel (CMP)
1
Exercise Group
1
Dobutamine + Goal-Directed Fluid Therapy

Awards & Highlights

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

Trial Design

2 Treatment Groups

Dulaglutide Arm
1 of 2
Placebo Arm
1 of 2

Experimental Treatment

Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Dulaglutide Injection · Has Placebo Group · Phase 4

Dulaglutide Arm
Drug
Experimental Group · 1 Intervention: Dulaglutide Injection · Intervention Types: Drug
Placebo Arm
Other
PlaceboComparator Group · 1 Intervention: Saline Injection · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 7 days postoperatively

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,558 Previous Clinical Trials
2,765,681 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
232 Previous Clinical Trials
93,535 Total Patients Enrolled
Francisco Pasquel, MD, MPHPrincipal Investigator - Emory University
Emory University

Eligibility Criteria

Age 40 - 80 · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

Is the study open to individuals above a certain age?

"This trial is only suitable for individuals aged 40 to 80. For those that are younger or older, there are alternative clinical trials available." - Anonymous Online Contributor

Unverified Answer

What medical conditions can be addressed with Dulaglutide Injection?

"Dulaglutide Injection is a popular medication for treating type 2 diabetes mellitus. This injection can also reduce cardiovascular risk, support proper diet and exercise regimens, and more." - Anonymous Online Contributor

Unverified Answer

What is the current enrollment size for this clinical trial?

"Affirmative, the details available on clinicaltrials.gov affirms that this trial is actively searching for suitable participants. This investigation commenced on March 8th 2019 and was most recently edited on August 2nd 2022. The study intends to recruit 60 individuals across 3 sites." - Anonymous Online Contributor

Unverified Answer

Are there particular types of participants deemed most advantageous for this research?

"This medical study is seeking 60 individuals, aged between 40 to 80 years old and with a BMI of 25mg/kg2 or higher, who are currently suffering from hyperglycemia. An additional requirement for potential participants involves having no prior history of diabetes or hyperglycemia." - Anonymous Online Contributor

Unverified Answer

Are there any remaining slots available for participants in this clinical experiment?

"Affirmative. Clinicaltrials.gov records indicate that recruitment for this medical research, which was first posted in March 2019, is ongoing. The study requires the enlistment of 60 people from 3 different sites." - Anonymous Online Contributor

Unverified Answer

What potential adverse effects might arise from Dulaglutide Injection?

"The safety of Dulaglutide Injection has been thoroughly established, scoring a 3 on our 1-3 scale due to the completion of Phase 4 clinical trials." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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