Dulaglutide for Stress Hyperglycemia

No longer recruiting at 1 trial location

Overseen By Georgia Davis, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Emory University

Must not be taking: Antihyperglycemics, Corticosteroids

Disqualifiers: Cardiac surgery, Renal failure, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Up to 14 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines methods to prevent high blood sugar levels in individuals without diabetes who are undergoing surgery. It will test whether an injectable diabetes medication, dulaglutide (also known as Trulicity), can maintain normal blood sugar levels before surgery. Participants will receive either dulaglutide or a placebo—a harmless substance resembling the drug but with no effect—prior to their surgery. Ideal participants are adults with a BMI over 30, undergoing non-cardiac surgery, and diagnosed with pre-diabetes or diabetes based on common tests. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

Do I have to stop taking my current medications for the trial?

Yes, if you are taking antihyperglycemic medications, you cannot participate in the trial.

What is the safety track record for these treatments?

Research has shown that dulaglutide is generally safe for people. It effectively lowers blood sugar levels and aids in weight loss. In these studies, participants taking dulaglutide reported side effects similar to those taking a placebo (a harmless pill used for comparison).

For example, some experienced minor stomach issues, like nausea, but these were usually mild and temporary. Overall, dulaglutide is safe at different doses, meaning it is typically safe for most people when used as directed.

Since dulaglutide is already approved for treating diabetes, it has undergone extensive testing in many studies. This extensive research gives doctors confidence in its safety. Prospective trial participants might find this information helpful in understanding what to expect regarding safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Dulaglutide is unique because it targets stress hyperglycemia, a condition often managed with insulin or oral medications that primarily lower blood sugar levels. Unlike these standard treatments, dulaglutide is a GLP-1 receptor agonist, which not only helps control blood sugar but also may offer additional benefits like weight management and improved cardiovascular outcomes. Researchers are excited about dulaglutide because it provides a dual-action approach, addressing both glucose levels and overall metabolic health, potentially offering a more comprehensive treatment for patients undergoing surgery.

What evidence suggests that dulaglutide might be an effective treatment for stress hyperglycemia?

In this trial, participants will be randomized to receive either dulaglutide or a placebo within 72 hours before a planned surgery. Research has shown that dulaglutide helps control blood sugar levels. Patients using dulaglutide experienced fewer heart-related issues, regardless of their initial blood sugar levels. Dulaglutide also improves blood sugar control, even when other medications, such as glucocorticoids, raise it. This suggests that dulaglutide can help manage high blood sugar levels often seen during surgery, potentially reducing the risk of complications afterward. ^{2 6 7 8 9}

Who Is on the Research Team?

Georgia Davis, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 45-80 years old, have a BMI of 30 or more, and have pre-diabetes or diabetes but no history of diabetes, undergoing certain surgeries.

I am between 45-80 years old, have a BMI of 30 or more, and no known diabetes, planning to undergo surgery.

Exclusion Criteria

I am undergoing heart surgery or expected to need intensive care.

Pregnant or breast feeding at time of enrollment

I am taking steroids stronger than 5 mg of prednisone daily.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Preoperative Evaluation

Participants undergo evaluation with OGTT and lab testing with CGM placement within 72 hours prior to planned surgery

3 days

1 visit (in-person)

Treatment

Participants receive a subcutaneous injection of dulaglutide or placebo and glycemic control parameters are followed postoperatively

Up to 14 days

Daily monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Continuous glucose monitor (CGM)
• Dulaglutide
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Dulaglutide Experimental Treatment 2 Interventions

Participants randomized to receive dulaglutide within 72 hours prior to a planned surgery.

Group II: Placebo Placebo Group 2 Interventions

Participants randomized to receive a placebo to match dulaglutide within 72 hours prior to a planned surgery.

Dulaglutide is already approved in United States, European Union for the following indications:

Approved in United States as Trulicity for:

• Type 2 diabetes mellitus
• Cardiovascular risk reduction in adults with established cardiovascular disease or multiple cardiovascular risk factors

Approved in European Union as Trulicity for:

• Type 2 diabetes mellitus
• Cardiovascular risk reduction in adults with established cardiovascular disease or multiple cardiovascular risk factors

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Dulaglutide (Trulicity™) is an effective once-weekly treatment for type 2 diabetes, showing significant improvements in glycemic control compared to oral metformin and non-inferiority to daily liraglutide in trials lasting up to 104 weeks.

It is generally well tolerated with a low risk of hypoglycemia, although gastrointestinal side effects like nausea and diarrhea are common; it also helps with weight loss, particularly at the higher dose of 1.5 mg.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dulaglutide: A Review in Type 2 Diabetes. Burness, CB., Scott, LJ.[2015]

Dulaglutide (Trulicity™) is a long-acting GLP-1 receptor agonist specifically designed for treating type 2 diabetes, demonstrating a novel mechanism of action by mimicking the effects of the GLP-1 hormone.

The drug has received approval for subcutaneous use in the US and is recommended for approval in the EU, indicating its efficacy and safety profile in managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dulaglutide: first global approval. Sanford, M.[2021]

Dulaglutide (Trulicity®) is an effective once-weekly treatment for type 2 diabetes, showing greater glucose-lowering effects compared to metformin, sitagliptin, exenatide, and insulin glargine in Phase III clinical trials involving various patient backgrounds.

It is considered non-inferior to liraglutide, another GLP-1 receptor agonist, and is currently reimbursed in Belgium for patients who have not achieved adequate control with dual oral therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dulaglutide (Trulicity®), a new once-weekly agonist of glucagon-like peptide-1 receptors for type 2 diabetes]. Scheen, AJ.[2016]

Dulaglutide (Trulicity®) is an effective once-weekly treatment for adults with type 2 diabetes, showing good tolerance and efficacy both as a standalone therapy and in combination with other diabetes medications, even in high-risk patients.

In the REWIND trial, dulaglutide significantly reduced the risk of major adverse cardiac events over a median follow-up of 5.4 years, highlighting its cardiovascular benefits alongside glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dulaglutide: A Review in Type 2 Diabetes. Scott, LJ.[2021]

Dulaglutide (Trulicity) is a once-weekly GLP-1 agonist that has been approved for the treatment of type 2 diabetes, providing a convenient dosing schedule for patients.

As the third GLP-1 agonist available, dulaglutide offers an effective option for managing blood sugar levels in individuals with type 2 diabetes, contributing to improved glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dulaglutide (Trulicity): The Third Once-Weekly GLP-1 Agonist. Smith, LL., Mosley, JF., Parke, C., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04862234

NCT04862234 | Perioperative Stress Hyperglycemia in ... 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 ...

2. trial.medpath.com trial.medpath.com/clinical-trial/d8954142aadae67f/nct04862234-perioperative-stress-hyperglycemia-surgery-patients

Perioperative Stress Hyperglycemia in General and Vascular ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9543284/

Efficacy and safety outcomes of dulaglutide by baseline HbA1c In dulaglutide‐treated patients, the incidence of CV outcomes was reduced by a similar degree in patients whose baseline HbA1c was less than 7% and 7% or higher ...

4. cardiab.biomedcentral.com cardiab.biomedcentral.com/articles/10.1186/s12933-020-01183-5

Efficacy of dulaglutide on vascular health indexes in subjects ... At the 9-month follow-up, subjects treated with dulaglutide showed significant lower values of the mean diastolic blood pressure, BMI, total ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7203793/

Dulaglutide improves glucocorticoid-induced ... The principal finding of this study is that Dula improved GC-induced hyperglycemia during inpatient care and was associated with a lower ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7896253/

Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus ... The additional glycemic benefit and weight loss were achieved with a safety profile similar to the 1.5-mg dose of dulaglutide. Two primary estimands were ...

7. nature.com nature.com/articles/s41598-022-22263-4

Efficacy and safety of dulaglutide compared with the first- ... To sum up, this meta-analysis indicated that dulaglutide (0.75 mg and 1.5 mg) could significantly decrease HbA1c and body weight in Asian T2DM ...

8. diabetesjournals.org diabetesjournals.org/care/article/38/12/2241/29030/Efficacy-and-Safety-of-Once-Weekly-Dulaglutide

Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin ... In AWARD-2, dulaglutide demonstrated expected glycemic efficacy and weight loss, consistent with published results from AWARD studies (15–18).

9. sciencedirect.com sciencedirect.com/science/article/pii/S0149291824001991

One-year Efficacy and Safety of Dulaglutide in Patients with ... Dulaglutide exhibited sustained glucose-lowering and weight-reduction effects during the initial 1 year of treatment in patients with diabetic kidney disease.