Cystic FibrosisPhase 2NCT04731272
GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance
A Phase 2 study testing Dulaglutide 0.75Mg/0.5Ml Inj Pen in people with Cystic Fibrosis and Pancreatic Insufficiency, run by University of Pennsylvania at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Pancreatic Insufficiency, Abnormal Glucose Tolerance
- What is being tested?
- Dulaglutide 0.75Mg/0.5Ml Inj Pen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jul 2021to 30 Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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)
- 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 administration regimen and complete study specific procedures (MMTT)
- 6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 weeks after the end of dulaglutide or observation administration; oral contraceptives, intra-uterine devices, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable
Who cannot join
- 1. BMI <19 kg/m2
- 2. Presence of first-degree atrioventricular block or other evidence for cardiac conduction system or structural heart defects
- 3. Pregnancy or lactation; a negative urine pregnancy test will be required at enrollment
- 4. Known allergic reactions to any GLP-1 agonist, and any history of severe hypersensitivity reactions (anaphylaxis or angioedema)
- 5. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 (MEN2)
- 6. Pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to study procedures
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- 7. Gastrointestinal symptom exacerbation defined by current nausea/vomiting or diarrhea
- 8. Established diagnosis of non-CF diabetes (e.g. type 1 diabetes) or CFRD with fasting hyperglycemia (fasting glucose ≥126 mg/dL [use of prandial insulin or repaglinide will be permitted])
- 9. History of clinically symptomatic pancreatitis within the last year
- 10. Prior lung, liver or other solid organ transplant
- 11. Severe CF liver disease, as defined by the presence of portal hypertension
- 12. History of fundoplication-related dumping syndrome
- 13. Hemoglobin <10 g/dL, within 90 days of study procedures or at screening
- 14. Abnormal renal function, within 90 days of study procedures or at screening; defined as creatinine >2x upper limit of normal (ULN) or potassium >5.5mEq/L on non-hemolyzed specimen
- 15. 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Children's Hospital of Colorado
Aurora, Colorado, 80045
Hannah Wessel, 720-777-1880 ext. 71880, Hannah.Wessel@childrenscolorado.org
Christine Chan, MD, 720-777-0990 ext. 70990, Christinel.Chan@childrenscolorado.org
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Paola Alvarado, MS, 215-746-2081, Paola.Alvarado@pennmedicine.upenn.edu
Cornelia Dalton-Bakes, 215-746-2085, corneliv@pennmedicine.upenn.edu
About this study
Official title: Effect of GLP-1 Agonist Therapy on Insulin Secretion in Adults With Pancreatic Insufficient Cystic Fibrosis and Abnormal Glucose Tolerance: a Randomized, Open-label, Cross-over 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.
Read the detailed 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. 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.
- Being tested
- Dulaglutide 0.75Mg/0.5Ml Inj Pen
- Keywords
- Cystic Fibrosis Related Diabetes, Glucose Intolerance, Insulin Secretion, Glucagon-Like Peptide-1 (GLP-1)
- Medical subject headings
- Cystic Fibrosis, Exocrine Pancreatic Insufficiency, Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dulaglutide 0.75Mg/0.5Ml Inj PenDrug
Randomized, open-label, cross-over study of 6 weeks exposure to dulaglutide 0.75 mg subcutaneous weekly or observation.
| Study group | Role | What they receive |
|---|---|---|
| Dulaglutide | Experimental | 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. Receives: Drug: Dulaglutide 0.75Mg/0.5Ml Inj Pen |
| Observation | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early-phase insulin secretion
The primary outcome measure is the insulin secretory rate during the first 30-min during a mixed meal tolerance test (ISR-AUC30).
Measured: 18 weeks
Secondary outcomes (2)
Early-phase insulin secretion adjusted for glucose excursion
This secondary outcome measure is insulin secretory rate/glucose area under cure during the first 30-min during a mixed meal tolerance test (ISR-AUC30/ Glc-AUC30)
Measured: 18 weeks
Glucose tolerance
This secondary outcome measure is mixed meal tolerance test-related glucose area under the curve over 180 min (Glc-AUC180).
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start16 Jul 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Children's Hospital Colorado
- Responsible party
- Principal investigator, Michael R. Rickels, MD, MS, University of Pennsylvania
- Investigators
- Michael R Rickels, MD, MS, Principal investigator, University of PennsylvaniaAndrea Kelly, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731272
- Sponsor's protocol ID
- 848357
- Status last verified
- May 2026
- First submitted
- 26 Jan 2021
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of enrollment.