GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance

• Register: ClinicalTrials.gov
• Last refreshed on: 5 May 2025
• Main ID: NCT04731272
• Date of registration: 26/01/2021
• Prospective Registration: Yes
• Primary sponsor: University of Pennsylvania
• Public title: GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance
• Scientific 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
• Date of first enrolment: July 16, 2021
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04731272
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Paola Alvarado, MS

• Name: Michael R Rickels, MD, MS
• Affiliation: University of Pennsylvania

• Name: Andrea Kelly, MD, MSCE
• Affiliation: Children's Hospital of Philadelphia

Key inclusion & exclusion criteria

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
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

Exclusion Criteria:

-

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


Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pancreatic Insufficiency

Diabetes

Abnormal Glucose Tolerance

Cystic Fibrosis

Intervention(s)

Drug: Dulaglutide 0.75Mg/0.5Ml Inj Pen

Primary Outcome(s)

Early-phase insulin secretion [Time Frame: 18 weeks]

Secondary Outcome(s)

Glucose tolerance [Time Frame: 18 weeks]

Early-phase insulin secretion adjusted for glucose excursion [Time Frame: 18 weeks]

Secondary ID(s)

848357

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Children's Hospital of Philadelphia

Children's Hospital Colorado