NCT04731272 · University of Pennsylvania
GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Dulaglutide 0.75Mg/0.5Ml Inj Pen
Randomized, open-label, cross-over study of 6 weeks exposure to dulaglutide 0.75 mg subcutaneous weekly or observation.
Primary outcome measures
Early-phase insulin secretion
Time frame: 18 weeks
The primary outcome measure is the insulin secretory rate during the first 30-min during a mixed meal tolerance test (ISR-AUC30).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 1\. Male or female, aged ≥18 years on date of consent
- 2\. Confirmed diagnosis of CF, defined by positive sweat test or Cystic Fibrosis transmembrane conductance regulator (CFTR) mutation analysis according to Cystic Fibrosis Foundation (CFF) diagnostic criteria.
- 3\. Pancreatic insufficiency defined by clinical requirement for pancreatic enzyme replacement.
- 4\. Abnormal glucose tolerance defined by OGTT criteria for EGI, IGT, or CFRD, or diagnosed CFRD. 1. There will be no restriction on enrollment of individuals with CFRD but without fasting hyperglycemia (fasting hyperglycemia is defined as fasting glucose ≥126 mg/dL) 2. Individuals with CFRD and fasting hyperglycemia (defined as above or by the use of basal insulin therapy) must also have a HbA1c ≤8% and a random (non-fasting) C-peptide ≥1.2 ng/mL17; enrollment of this subgroup will be limited to n =10.
- 5\. Ability to take subcutaneous medication and be willing to adhere to the weekly administratio
Where
- Aurora, Colorado
- Philadelphia, Pennsylvania
Collaborators
Children's Hospital of Philadelphia, Children's Hospital Colorado
Related conditions & keywords
Frequently asked questions
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Will I receive a placebo instead of treatment?
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Data: ClinicalTrials.gov · synced May 18, 2026 · Source of record for eligibility and locations