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GLP-1 Agonist
GLP-1 Agonist Therapy for Cystic Fibrosis-related Diabetes
Phase 2
Recruiting
Led By Andrea Kelly, MD, MSCE
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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Early-phase insulin secretion
Secondary outcome measures
Early-phase insulin secretion adjusted for glucose excursion
Glucose tolerance
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
2,002 Previous Clinical Trials
42,880,969 Total Patients Enrolled
26 Trials studying Diabetes
71,956 Patients Enrolled for Diabetes
Children's Hospital of PhiladelphiaOTHER
708 Previous Clinical Trials
8,581,245 Total Patients Enrolled
4 Trials studying Diabetes
210 Patients Enrolled for Diabetes
Andrea Kelly, MD, MSCEPrincipal InvestigatorChildren's Hospital of Philadelphia
4 Previous Clinical Trials
321 Total Patients Enrolled
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Dulaglutide 0.75Mg/0.5Ml Inj Pen?
"Our team at Power rated the safety of Dulaglutide 0.75Mg/0.5Ml Inj Pen as a 2 due to limited evidence on efficacy, yet some data supporting its overall security in Phase 2 trials."
Answered by AI
In what circumstances is Dulaglutide 0.75Mg/0.5Ml Inj Pen typically administered?
"Dulaglutide 0.75Mg/0.5Ml Inj Pen is frequently prescribed to type 2 diabetes mellitus sufferers but can also be beneficial in the management of cardiovascular risk, dietary intervention, and physical activity regimes."
Answered by AI
Are there vacancies available in this clinical exploration for participants?
"Affirmative. Per the clinicaltrials.gov listing, this medical experiment is actively recruiting participants and was initially made public on April 20th 2021, with its most recent edit occurring on January 7th 2022. The study seeks to enroll 30 patients at one specific site."
Answered by AI
What is the total population involved in this research project?
"Correct. The details on clinicaltrials.gov indicate that the medical trial is actively recruiting, with its first post date being April 20th 2021 and the most recent edit occurring on January 7th 2022. 30 patients are sought from a single location."
Answered by AI
Who else is applying?
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
How responsive is this trial?
Average response time
- < 1 Day
Most responsive sites:
- University of Pennsylvania: < 24 hours
Typically responds via
Email
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