CompletedPhase NAResults posted

Effect of Chronic Incretin-based Therapy in Cystic Fibrosis

A Randomized, Double-blind, Placebo Controlled Study of the Effectiveness of Chronic Incretin-based Therapy on Insulin Secretion in Cystic Fibrosis

Lead sponsor

University of Pennsylvania

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Actual enrollment

Study population

Eligibility highlights

Primary endpoint

•Second-phase Insulin Response Derived From the Glucose-potentiated Arginine

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01879228

Org study ID818014

Timeline

Milestones

Study first posted2013-06-17estimated

Results first posted2022-02-09actual

Last update posted2022-03-08actual

Study start2013-06 (month precision)

Primary completion2019-12actual (month precision)

Study completion2020-03actual (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Confirmed diagnosis of CF, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria

•Age ≥ 18y on date of consent

•Pancreatic insufficiency

•Recent OGTT consistent with Indeterminate-GT, IGT, CFRD w/o fasting hyperglycemia, or an established diagnosis of CFRD without fasting hyperglycemia

•For female subjects, negative urine pregnancy test at enrollment.

Exclusion criteria

•Established diagnosis of non-CF diabetes (i.e. T1D) or CFRD with fasting hyperglycemia, (fasting glucose > 126 mg/dL)

•History of clinically symptomatic pancreatitis within last year,

•Prior lung or liver transplant,

•Severe CF liver disease, as defined by portal hypertension,

•Fundoplication-related dumping syndrome,

•Medical co-morbidities that are not CF-related or are unstable per investigator opinion (i.e. history of bleeding disorders, immunodeficiency),

•Acute illness or changes in therapy (including antibiotics) within 6 weeks prior to enrollment,

•Treatment with oral or intravenous corticosteroids within 6 weeks of enrollment,

•Hemoglobin <10g/dL, within 90 days of Visit 1 or at Screening,

•Abnormal renal function, within 90 days of Visit 1 or at Screening; defined as Creatinine clearance < 50 mL/min (based on the Cockcroft-Gault formula) or potassium > 5.5mEq/L on non-hemolyzed specimen,

•A history of anaphylaxis, angioedema or Stevens-Johnson syndrome,

•Inability to perform study specific procedures (MMTT, GPA),

•Subjects, who in study team opinion, may be non-compliant with study procedures.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

Change in Second-phase Insulin Response Derived From the Glucose-potentiated Arginine Test as a Measure of β-cell Sensitivity to Glucose at Baseline and at 6 Months

Time frame:Baseline and 6 months

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.