Prevention of Cystic Fibrosis Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00967798
• Date of registration: 27/08/2009
• Prospective Registration: Yes
• Primary sponsor: Emory University
• Public title: Prevention of Cystic Fibrosis Diabetes Prevent
• Scientific title: A Randomized, Double-blind, Placebo-controlled Study to Determine Whether Chronic Treatment of Cystic Fibrosis Subjects With Impaired Glucose Tolerance Using Sitagliptin (Januvia) Prevents the Development of Diabetes
• Date of first enrolment: May 2010
• Target sample size: 33
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00967798
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: Arlene A Stecenko, MD
• Affiliation: Emory University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Aged 13 years of age or older at the time of enrollment

- Diagnosis of cystic fibrosis (CF) confirmed by pilocarpine iontophoresis sweat
chloride measurements and/or genotyping

- Clinically stable with no lower respiratory tract exacerbation requiring intravenous
antibiotics in the three weeks prior to enrollment

- On a stable clinical treatment regimen for at least three weeks prior to enrollment

- Male or female. If female, is not lactating and has a negative pregnancy test at
screening. If female of child bearing potential, willing to practice effective birth
control (i.e. a method known to decrease the risk of pregnancy to less than 1%)

- Able to understand and provide informed consent

- Willing and able to comply with the study schedule and testing

- High risk prediabetes as defined by high-risk impaired fasting glucose levels of
110-125 mg/dl and/or a 2-hour plasma glucose level of 140 to 199 mg/dl found on an
Oral Glucose Tolerance Test performed at screening 8 weeks or less before enrollment

- Available by telephone

- Has literacy and language skills required to fill out study material

Exclusion Criteria:

- Diagnosed with CF related diabetes

- Chronic heart failure with New York Heart Association (NYHA) class III/IV, ejection
fraction less than 25%, or receiving digoxin

- Liver disease as defined by alanine aminotransferase (ALT) or aspartate
aminotransferase (AST) three times above the upper limit of normal.

- Serum creatinine greater than 1.3 mg/dl for males and greater than 1.1 mg/dl for
females or receiving chronic dialysis

- Taking chronic oral or intravenous glucocorticosteroids during the past month

- On insulin therapy during the past month

- CF lung disease severe enough to require daytime chronic oxygen therapy via nasal
cannula during the past month

- Unable to perform pulmonary function testing

- History of any illness or condition that, in the opinion of the sponsor might confound
the results of the study or pose an additional risk in administering study drug to the
subject

- Post lung or liver transplant

- Listed and awaiting organ transplant

- Current drug or alcohol dependency

- Participating in another clinical drug trial or past participant within 30 days of
enrollment

- Pancreatic sufficient

- History of acute pancreatitis as documented by characteristic clinical manifestations
and elevation of serum amylase and lipase within the last 2 years.



Age minimum: 13 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Prediabetes

Intervention(s)

Drug: Sitagliptin

Primary Outcome(s)

Number of Participants With Conversion to Cystic Fibrosis Related Diabetes [Time Frame: Month 15]

Secondary Outcome(s)

Change in Percent Predicted FEV1 [Time Frame: Baseline, end of treatment (Month 12 or Month 24)]

Change in Inflammatory Cytokines [Time Frame: Baseline through Month 12]

Change in Beta-cell Disposition Index [Time Frame: Baseline through Month 15]

Change in Redox Couples Glutathione/Glutathione Disulfide and Cysteine/Cystine [Time Frame: Baseline through Month 12]

Secondary ID(s)

IRB00012724

1R01FD003527-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 25/06/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00967798