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New treatment option for Cystic Fibrosis
Official title GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance
ClinicalTrials.gov ID: NCT04731272
What this study is testing
What is Dulaglutide 0.75Mg/0.5Ml Inj Pen?
Dulaglutide 0.75Mg/0.5Ml Inj Pen is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for cystic fibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility 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.
- 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...
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.