Health TrialsbyHealthPanel

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

ConditionsCystic FibrosisPancreatic InsufficiencyAbnormal Glucose ToleranceDiabetes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Dulaglutide 0.75Mg/0.5Ml Inj Pen

    Drug

    Randomized, open-label, cross-over study of 6 weeks exposure to dulaglutide 0.75 mg subcutaneous weekly or observation.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: DulaglutideExperimental treatment 1 intervention
Group B: ObservationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Early-phase insulin secretion

The primary outcome measure is the insulin secretory rate during the first 30-min during a mixed meal tolerance test (ISR-AUC30).

Time frame
18 weeks

Secondary outcomes

1

Early-phase insulin secretion adjusted for glucose excursion

This secondary outcome measure is insulin secretory rate/glucose area under cure during the first 30-min during a mixed meal tolerance test (ISR-AUC30/ Glc-AUC30)

Time frame
18 weeks
2

Glucose tolerance

This secondary outcome measure is mixed meal tolerance test-related glucose area under the curve over 180 min (Glc-AUC180).

Time frame
18 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Children's Hospital of Philadelphia

Collaborator

Children's Hospital Colorado

Collaborator

Source ClinicalTrials.gov
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