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 (CF Dulaglutide)

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
Recruiting
18 years - 50 years
All
Phase N/A
30 participants needed
1 Location

Brief description of study

The research study is being conducted to better understand Cystic-Fibrosis Related Diabetes (CFRD) and to see the effects of an analog of the gut incretin hormone, GLP-1 (dulaglutide), has on individuals like with abnormal glucose tolerance. GLP-1 (dulaglutide) helps the pancreas release insulin, which controls blood sugar levels from getting too high and is currently prescribed to people with Type 2 diabetes. We are looking at how GLP-1 (dulaglutide) might help improve blood sugar levels for people with CF and abnormal glucose tolerance. 

Detailed description of study

If are eligible and you agree to join the study, you will be asked to complete the following research procedures:

  • A screening visit to go over your medical history and collect screening labs with a 2-hour Oral Glucose Tolerance Test (OGTT) to confirm your glucose tolerance level (unless you have a confirmed diagnosis of CFRD) ($100.00)

  • 4 Mixed Meal Tolerance Tests (MMTTs), two for each period of either drug intervention or observational ($300.00 per MMTT):

    • This test will look at your body’s response to food.  Prior to this visit, you will work with the study team to decide on a breakfast that is appealing to you but is comprised of a specific combination of calories, protein and carbohydrates.  You will take your routine pancreatic enzymes with this breakfast. (Please bring them to each MMTT) After you eat, you will have blood drawn from your IV multiple times over a 4-hour period.  The total amount of blood for this test is about 65mL or 4½ tablespoons.

Your participation will last for 18-24 weeks, 6 weeks on intervention, 6 weeks on observation, and 6 weeks of “wash-out” between.

 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cystic Fibrosis, Cystic-Fibrosis Related Diabetes, CFRD
  • Age: 18 years - 50 years
  • Gender: All

1. Confirmed diagnosis of CF, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria.
2. Pancreatic insufficiency defined by clinical requirement for pancreatic enzyme replacement. 
3. Abnormal glucose tolerance defined by OGTT criteria for EGI, IGT, or CFRD without fasting hyperglycemia (fasting hyperglycemia is defined as fasting glucose ≥126 mg/dL) 
4. Ability to take subcutaneous medication and be willing to adhere to the weekly administration regimen and complete study specific procedures (MMTT)
5. 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 
6. Agreement to adhere to Lifestyle Considerations throughout study duration

Updated on 02 Jul 2025. Study ID: 21-0132

Pre-Screener

Check if you are eligible Enter contact details Select a study center Select best time to contact

Do you have cystic fibrosis?

Preview complete

The prescreener preview is complete. You may now close the preview.

Interested in the study

Select a study center that’s convenient for you, and get in touch with the study team.

Contact a study center