GLP-1 Agonist Therapy for Cystic Fibrosis-related Diabetes

Recruiting at 1 trial location

Overseen By Paola Alvarado, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Pennsylvania

Must be taking: GLP-1 agonists

Disqualifiers: Low BMI, Heart defects, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 6 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether dulaglutide, a GLP-1 agonist therapy, can improve insulin production and sugar levels in people with cystic fibrosis-related diabetes. The study targets individuals with cystic fibrosis who need enzyme replacement therapy and have glucose tolerance issues. Participants will either receive dulaglutide or be observed without intervention to compare outcomes. Those with cystic fibrosis, diabetes-related glucose issues, and a need for enzyme therapy might be suitable for this study. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using prandial insulin or repaglinide for diabetes, you may continue these medications during the study.

Is there any evidence suggesting that dulaglutide is likely to be safe for humans?

Research shows that dulaglutide, a type of medication, is generally safe for people with type 2 diabetes. A large study with nearly 5,000 participants found dulaglutide to be well-tolerated, with most people not experiencing serious side effects. Common mild side effects included nausea, diarrhea, and vomiting, which usually improved over time.

Dulaglutide is already used to help control blood sugar levels and support weight loss in people with type 2 diabetes. This suggests it might also be safe for other conditions, such as diabetes related to cystic fibrosis, although more research is needed.

The current trial phase focuses on the safety of this treatment for people with cystic fibrosis-related diabetes. While some evidence of its safety exists, the trial will provide more specific information for this condition. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cystic fibrosis-related diabetes?

Unlike the standard of care for cystic fibrosis-related diabetes, which typically involves insulin therapy to manage blood sugar levels, dulaglutide offers a novel approach by utilizing a GLP-1 agonist mechanism. This treatment works by enhancing insulin secretion and suppressing glucagon release, which can lead to better blood sugar control with potentially fewer side effects. Researchers are excited about dulaglutide because it not only targets blood sugar levels but may also provide additional benefits such as weight management and improved overall metabolic health, which are crucial for individuals with cystic fibrosis.

What evidence suggests that dulaglutide might be an effective treatment for cystic fibrosis-related diabetes?

Research shows that dulaglutide, a type of medication, effectively lowers blood sugar levels in people with diabetes. Studies have found that dulaglutide works better than a placebo and some other diabetes drugs in controlling blood sugar. For people with cystic fibrosis-related diabetes (CFRD), maintaining stable blood sugar levels is crucial. Early research suggests that dulaglutide may help the body produce more insulin and improve sugar metabolism, both essential for managing CFRD. In this trial, participants will either receive dulaglutide therapy or join an observation group with no intervention, highlighting dulaglutide as a promising treatment option for diabetes linked to cystic fibrosis. ^{1 3 6 7 8}

Who Is on the Research Team?

Michael Rickels, MD, MS

Principal Investigator

University of Pennsylvania

Andrea Kelly, M.D, M.S.

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

Adults aged 18+ with cystic fibrosis, pancreatic insufficiency requiring enzyme replacement, and abnormal glucose tolerance but not full-blown diabetes can join. They must be able to take weekly subcutaneous medication and follow the study's procedures. Women should use effective contraception.

Inclusion Criteria

Abnormal glucose tolerance defined by OGTT criteria for EGI, IGT, or CFRD, or diagnosed CFRD

I need medication to help my pancreas work.

I have been diagnosed with Cystic Fibrosis based on a sweat test or genetic test.

Exclusion Criteria

I have diabetes (not CF related) or CFRD with high fasting blood sugar.

I or my family have a history of medullary thyroid cancer or MEN2.

History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk to the subject

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Participants undergo a Mixed Meal Tolerance Test at baseline and after 6 weeks of no intervention

6 weeks

2 visits (in-person)

Treatment

Participants receive weekly administration of dulaglutide and undergo a Mixed Meal Tolerance Test at baseline and after 6 weeks

6 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dulaglutide

Trial Overview The trial is testing if a weekly shot of Dulaglutide, a GLP-1 agonist, can help improve insulin secretion and glucose tolerance in people with cystic fibrosis who have issues with blood sugar levels.

How Is the Trial Designed?

Group I: Dulaglutide Experimental Treatment 1 Intervention

The Mixed Meal Tolerance Test as described in the primary outcome section will be performed at baseline and after 6 weeks of dulaglutide therapy in the intervention period.

Group II: Observation Active Control 1 Intervention

The Mixed Meal Tolerance Test as described in the primary outcome section will be performed at baseline and after 6 weeks of no intervention in the observation period.

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?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Published Research Related to This Trial

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, a GLP-1 receptor agonist, has shown superior efficacy in lowering blood sugar levels compared to placebo and other diabetes medications, making it a strong option for treating type 2 diabetes.

The drug is administered once a week, has a favorable safety profile with common gastrointestinal side effects, and offers patient satisfaction similar to other GLP-1 receptor agonists, while also promoting weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the treatment of type 2 diabetes: impact of dulaglutide. Thompson, AM., Trujillo, JM.[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 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 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]

Citations

1. pennmedicine.org pennmedicine.org/physicians-hub/clinical-briefing/dulaglutide-study

Enrolling trial: GLP-1 agonist therapy in cystic fibrosis A research study at Penn Medicine is investigating the effects of dulaglutide in adults with cystic fibrosis and abnormal glucose tolerance.

2. withpower.com withpower.com/trial/phase-3-fibrosis-3-2021-b36c2

GLP-1 Agonist Therapy for Cystic Fibrosis-related Diabetes Dulaglutide, a GLP-1 receptor agonist, has shown superior efficacy in lowering blood sugar levels compared to placebo and other diabetes medications, making it ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04731272/glp-1-agonist-therapy-in-cystic-fibrosis-related-glucose-intolerance

GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose ... In this study, we hypothesize that weekly administration of the long-acting glucagon-like peptide-1 (GLP-1) agonist dulaglutide will improve ...

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.16516?af=R

Glucagon‐like peptide‐1 receptor agonists in adults with ... In another case series, sitagliptin maintained satisfactory glucose control for at least 5 years in three patients with CFRD and pancreatic ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10915598/

The Changing Landscape of Treatment for Cystic Fibrosis ... The secondary outcomes were changes in HbA1c and diabetes regimen. Methods. This is a retrospective chart review study. Data were retrieved ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12326930/

Glucagon‐like peptide‐1 receptor agonists in adults with ... In most cases, these treatments led to meaningful improvements in glycaemic control, significant weight loss, more stable glucose profiles on ...

7. pharmacytimes.com pharmacytimes.com/view/dulaglutide-biosimilar-achieves-equivalent-efficacy-in-hba1c-reduction-in-patients-with-t2dm

Dulaglutide Biosimilar Achieves Equivalent Efficacy in ... A new biosimilar, LY05008, shows comparable efficacy and safety to dulaglutide in managing type 2 diabetes mellitus (T2DM) in Chinese adults.

8. ema.europa.eu ema.europa.eu/en/documents/variation-report/trulicity-h-c-2825-ii-0040-epar-assessment-report-variation_en.pdf

Trulicity, INN-dulaglutide - EMA Study GBDJ (REWIND) provides safety data from 4949 dulaglutide-treated and 4952 placebo-treated patients with T2D who, compared to patients ...