Sitagliptin in Cystic Fibrosis-Related Diabetes
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effects of the DPPIV Inhibitor Sitagliptin in Cystic Fibrosis-related Diabetes|
- Insulin release [ Time Frame: 180 minutes (during clamp) ] [ Designated as safety issue: No ]The study protocol is a iv-oral hyperglycemic glucose clamp. We will assess insulin release during the clamp, comparing placebo to sitagliptin.
- Incretin Response [ Time Frame: 180 minutes (during clamp) ] [ Designated as safety issue: No ]We will assess incretin release [glucoagon-like peptide-1 (GLP-1), gastric inhibitory polypeptide(GIP)] during the glucose clamp.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Sitagliptin||
100mg po one dose
Other Name: Januvia, MK-0431, Dipeptidyl peptidase IV inhibitor (DPP-4 inhibitor)
|Placebo Comparator: Placebo||
Sugar pill po one dose
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.
|Contact: Sara G Stafford, MDCMemail@example.com|
|Contact: Chris Lockhart||604-875-4111 ext firstname.lastname@example.org|
|Canada, British Columbia|
|University of British Columbia Gerontology & Diabetes Reserach Centre (ViTALITY)||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 1L8|
|Contact: Chris Lockhart 604-875-4111 ext 68535 email@example.com|
|Principal Investigator:||Graydon Meneilly, MD||University of British Columbia|