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NCT04731272 · ClinicalTrials.gov registry record · Phase 2
GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance
A Phase 2 study of Diabetes and Cystic Fibrosis, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT04731272: Recruiting Phase 2 study of Diabetes and Cystic Fibrosis, sponsored by University of Pennsylvania.
NCT04731272 is a Phase 2 study of Diabetes and Cystic Fibrosis that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 30 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04731272, a Phase 2 study of Diabetes and Cystic Fibrosis, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
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. Identifying interventions to preserve β-cell function are crucial for delaying and potentially preventing CFRD development. In this study, we hypothesize that weekly administration of the long-acting glucagon-like peptide-1 (GLP-1) agonist dulaglutide will improve defective early-phase insulin secretion and improve glucose tolerance during a mixed-meal tolerance test.
Primary Outcome
The primary outcome measure is the insulin secretory rate during the first 30-min during a mixed meal tolerance test (ISR-AUC30).
Conditions Studied
Interventions
- DRUG Dulaglutide 0.75Mg/0.5Ml Inj Pen
Study Locations (2)
Colorado
- Children's Hospital of Colorado - Aurora
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-07-16 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
What NCT04731272 shows while recruiting
NCT04731272 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Dulaglutide 0.75Mg/0.5Ml Inj Pen is the first listed.
NCT04731272 reports a single indexed study location in Colorado, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04731272 about?
NCT04731272 is a clinical study titled "GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance". 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...
What is the current status of trial NCT04731272?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2021-07-16. Estimated completion is 2027-06-30.
What conditions does trial NCT04731272 study?
This clinical trial studies the following conditions: Diabetes, Cystic Fibrosis, Pancreatic Insufficiency, Abnormal Glucose Tolerance.
What interventions are being tested in trial NCT04731272?
The interventions under investigation include: Dulaglutide 0.75Mg/0.5Ml Inj Pen (DRUG).
Who is sponsoring clinical trial NCT04731272?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04731272 being conducted?
This trial has 2 study locations across Colorado, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04731272's enrollment target sits among peer trials
30 281st of 338 higher than 51 of 338 other Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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