GLP-1 Agonist Therapy for Cystic Fibrosis-related Diabetes
Trial Summary
What is the purpose of this trial?
Diabetes is a major co-morbidity in pancreatic insufficient cystic fibrosis (PI-CF) and associated with worse outcomes. While reduced β-cell mass contributes to the insulin secretory defects that characterizes cystic fibrosis-related diabetes (CFRD), other modifiable determinants appear operative in the emergence and progression of abnormal glucose tolerance towards diabetes. Identifying interventions to preserve β-cell function are crucial for delaying and potentially preventing CFRD development. In this study, we hypothesize that weekly administration of the long-acting glucagon-like peptide-1 (GLP-1) agonist dulaglutide will improve defective early-phase insulin secretion and improve glucose tolerance during a mixed-meal tolerance test.
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.
What data supports the effectiveness of the drug Dulaglutide (Trulicity) for treating cystic fibrosis-related diabetes?
Dulaglutide (Trulicity) is effective in lowering blood sugar levels in people with type 2 diabetes, and it also helps with weight reduction and reducing the risk of major heart problems. While this data is specific to type 2 diabetes, it suggests potential benefits for managing blood sugar in other conditions like cystic fibrosis-related diabetes.12345
Is dulaglutide (Trulicity) safe for humans?
How is the drug Dulaglutide unique for treating cystic fibrosis-related diabetes?
Research Team
Michael Rickels, MD, MS
Principal Investigator
University of Pennsylvania
Andrea Kelly, M.D, M.S.
Principal Investigator
Children's Hospital of Philadelphia
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Observation
Participants undergo a Mixed Meal Tolerance Test at baseline and after 6 weeks of no intervention
Treatment
Participants receive weekly administration of dulaglutide and undergo a Mixed Meal Tolerance Test at baseline and after 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dulaglutide
Dulaglutide is already approved in United States, European Union for the following indications:
- Type 2 diabetes mellitus
- Cardiovascular risk reduction in adults with established cardiovascular disease or multiple cardiovascular risk factors
- Type 2 diabetes mellitus
- Cardiovascular risk reduction in adults with established cardiovascular disease or multiple cardiovascular risk factors
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Children's Hospital Colorado
Collaborator
Children's Hospital of Philadelphia
Collaborator