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GLP-1 Agonist
GLP-1 Agonist Therapy for Cystic Fibrosis-related Diabetes
Phase 2
Recruiting
Led By Michael R Rickels, MD, MS
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at whether a weekly injection of a medication called dulaglutide can help improve early-phase insulin secretion and glucose tolerance in people with cystic fibrosis-related diabetes.
Who is the study for?
Adults aged 18+ with cystic fibrosis, pancreatic insufficiency requiring enzyme replacement, and abnormal glucose tolerance but not full-blown diabetes can join. They must be able to take weekly subcutaneous medication and follow the study's procedures. Women should use effective contraception.
What is being tested?
The trial is testing if a weekly shot of Dulaglutide, a GLP-1 agonist, can help improve insulin secretion and glucose tolerance in people with cystic fibrosis who have issues with blood sugar levels.
What are the potential side effects?
Dulaglutide may cause digestive problems like nausea or diarrhea, potential pancreatitis (inflamed pancreas), allergic reactions including anaphylaxis or angioedema (severe swelling), and could affect heart rhythm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Early-phase insulin secretion
Secondary study objectives
Early-phase insulin secretion adjusted for glucose excursion
Glucose tolerance
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DulaglutideExperimental Treatment1 Intervention
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.
Group II: ObservationActive Control1 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.
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,081 Previous Clinical Trials
42,724,790 Total Patients Enrolled
27 Trials studying Diabetes
72,389 Patients Enrolled for Diabetes
Children's Hospital of PhiladelphiaOTHER
731 Previous Clinical Trials
8,473,004 Total Patients Enrolled
4 Trials studying Diabetes
210 Patients Enrolled for Diabetes
Michael R Rickels, MD, MSPrincipal InvestigatorUniversity of Pennsylvania
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need medication to help my pancreas work.I have diabetes (not CF related) or CFRD with high fasting blood sugar.I or my family have a history of medullary thyroid cancer or MEN2.My blood sugar levels are abnormal but not due to fasting hyperglycemia.I am 18 years old or older.I have needed strong antibiotics or steroids for a lung issue in the last 4 weeks.I have a heart condition affecting its electrical activity or structure.I have been diagnosed with Cystic Fibrosis based on a sweat test or genetic test.I need medication to help my pancreas work.I have experienced dumping syndrome after fundoplication surgery.I have had painful pancreatitis in the past year.I have severe liver disease due to cystic fibrosis, indicated by high blood pressure in the liver.I am currently experiencing severe nausea, vomiting, or diarrhea.I have had a lung, liver, or other solid organ transplant.My kidney function is not normal, with high creatinine or potassium levels.I can take medication under the skin and follow a weekly plan.I am using or agree to use effective birth control during and 6 weeks after the study.I have been diagnosed with Cystic Fibrosis based on a sweat test or genetic test.
Research Study Groups:
This trial has the following groups:- Group 1: Observation
- Group 2: Dulaglutide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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