A Phase 2 interventional study of Sitagliptin and Placebo in Cystic Fibrosis, sponsored by University of British Columbia. Terminated at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2014-03-06.
Sponsored by University of British Columbia · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether the dipeptidyl peptidase IV (DPPIV) inhibitor sitagliptin is effective in the treatment of cystic fibrosis-related diabetes (CFRD). We hypothesize that sitagliptin will improve meal-stimulated insulin secretion.
To date, no clinical trials have been conducted using the DPPIV inhibitor sitagliptin in cystic fibrosis-related diabetes. Cystic fibrosis-related diabetes is characterized initially by post-prandial hyperglycemia, with normal fasting sugars. As the disease progresses, fasting hyperglycemia develops. As sitagliptin augments post-prandial insulin release, while avoiding fasting hypoglycemia, it may be an alternative therapy for cystic fibrosis-related diabetes in individuals who do not yet require basal insulin therapy.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 3 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Sitagliptin
Drug: Placebo
100mg po one dose
Also known as: Januvia, MK-0431, Dipeptidyl peptidase IV inhibitor (DPP-4 inhibitor)
Sugar pill po one dose
Insulin release
The study protocol is a iv-oral hyperglycemic glucose clamp. We will assess insulin release during the clamp, comparing placebo to sitagliptin.
Time frame: 180 minutes (during clamp)
Incretin Response
We will assess incretin release \[glucoagon-like peptide-1 (GLP-1), gastric inhibitory polypeptide(GIP)\] during the glucose clamp.
Time frame: 180 minutes (during clamp)
This study is terminated, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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University of British Columbia