Effect of Chronic Incretin-based Therapy in Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 11 January 2021
• Main ID: NCT01879228
• Date of registration: 12/06/2013
• Prospective Registration: No
• Primary sponsor: University of Pennsylvania
• Public title: Effect of Chronic Incretin-based Therapy in Cystic Fibrosis
• Scientific title: A Randomized, Double-blind, Placebo Controlled Study of the Effectiveness of Chronic Incretin-based Therapy on Insulin Secretion in Cystic Fibrosis
• Date of first enrolment: June 2013
• Target sample size: 26
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01879228
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Michael M Rickels, MD
• Affiliation: University of Pennsylvania

Key inclusion & exclusion criteria

Inclusion Criteria:

- 1) Confirmed diagnosis of CF, defined by positive sweat test or CFTR mutation analysis
according to CFF diagnostic criteria, 2) age = 18y on date of consent, 3) pancreatic
insufficiency, 4) recent OGTT consistent with Indeterminate-GT, IGT, CFRD w/o fasting
hyperglycemia, or an established diagnosis of CFRD without fasting hyperglycemia, 5)
for female subjects, negative urine pregnancy test at enrollment.

Exclusion Criteria:

- 1) Established diagnosis of non-CF diabetes (i.e. T1D) or CFRD with fasting
hyperglycemia, (fasting glucose > 126 mg/dL) 2) history of clinically symptomatic
pancreatitis within last year, 3) prior lung or liver transplant, 4) severe CF liver
disease, as defined by portal hypertension, 5) fundoplication-related dumping
syndrome, 6) medical co-morbidities that are not CF-related or are unstable per
investigator opinion (i.e. history of bleeding disorders, immunodeficiency), 7) acute
illness or changes in therapy (including antibiotics) within 6 weeks prior to
enrollment, 8) treatment with oral or intravenous corticosteroids within 6 weeks of
enrollment, 9) hemoglobin <10g/dL, within 90 days of Visit 1 or at Screening, 10)
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, 11) a history of anaphylaxis, angioedema or
Stevens-Johnson syndrome, 12) Inability to perform study specific procedures (MMTT,
GPA), 13) Subjects, who in study team opinion, may be non-compliant with study
procedures.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Pancreatic Insufficiency

Intervention(s)

Drug: Sitagliptin

Primary Outcome(s)

Change in second-phase insulin response derived from the glucose-potentiated arginine test as a measure of ß-cell sensitivity to glucose at baseline and at 6 months [Time Frame: 6 months]

Secondary ID(s)

818014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Children's Hospital of Philadelphia