Dulaglutide for Stress Hyperglycemia

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: Unknown

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that the drug Dulaglutide for Stress Hyperglycemia is an effective treatment?

The available research shows that Dulaglutide, a drug used for type 2 diabetes, is effective in lowering blood sugar levels. It was found to be more effective than some other diabetes medications like metformin, sitagliptin, and exenatide. It also helped reduce body weight and had a low risk of causing low blood sugar. Although the research focuses on type 2 diabetes, these results suggest that Dulaglutide could be effective for managing stress hyperglycemia as well. ^{1 2 3 4 5}

What safety data exists for Dulaglutide (Trulicity)?

Dulaglutide (Trulicity) is generally well tolerated with a low inherent risk of hypoglycemia. The most frequently reported adverse events in clinical trials were gastrointestinal-related, such as nausea, vomiting, and diarrhea. It has been evaluated in various clinical trials, including the AWARD program and the REWIND CV outcomes trial, demonstrating its efficacy and safety in patients with type 2 diabetes. Dulaglutide is approved in numerous countries and is considered a useful option for managing type 2 diabetes due to its durable glycemic efficacy, beneficial effects on body weight, and low risk of hypoglycemia. ^{1 2 3 4 5}

Is the drug Dulaglutide (Trulicity) a promising treatment for stress hyperglycemia?

Yes, Dulaglutide (Trulicity) is a promising treatment. It is effective in lowering blood sugar levels, helps with weight loss, and reduces the risk of major heart problems. It is also convenient to use because it only needs to be taken once a week. ^{1 2 3 4 5}

Research Team

Georgia Davis, MD

Principal Investigator

Emory University

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

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

2. New Zealand pubmed.ncbi.nlm.nih.gov

Dulaglutide: first global approval. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Dulaglutide (Trulicity): The Third Once-Weekly GLP-1 Agonist. [2020]

4. Belgium pubmed.ncbi.nlm.nih.gov

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

5. New Zealand pubmed.ncbi.nlm.nih.gov

Dulaglutide: A Review in Type 2 Diabetes. [2015]