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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 June 2016 |
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Main ID: |
NCT01721382 |
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Date of registration:
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26/10/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis
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Scientific title:
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Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis. |
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Date of first enrolment:
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November 2012 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01721382 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Larry A Fox, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nemours Children's Clinic |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with CF between 13 and <21 yrs old
- Known impaired or indeterminate glucose tolerance (based on a prior OGTT)
- No history of CFRD
Exclusion Criteria:
- Insulin use in the last two months
- Acute pulmonary exacerbation / oral corticosteroid use in the last 6 weeks
- History of pancreatitis in the last 12 months
- Skin rashes or conditions that may affect CGM placement and wear
- Pregnancy or intent on becoming pregnant
- Patients on growth hormone therapy
- Renal insufficiency with creatinine clearance <50 ml/min (based on Schwartz formula)
Age minimum:
13 Years
Age maximum:
20 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Sitagliptin
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Primary Outcome(s)
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Response to sitagliptin
[Time Frame: Change from baseline to ~4 weeks of study drug]
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Secondary Outcome(s)
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Beta-cell function
[Time Frame: Change from baseline to ~4 weeks of study drug]
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Continuous glucose monitoring (CGM)
[Time Frame: change from baseline to ~4 weeks of study drug]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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