Sitagliptin in Cystic Fibrosis-Related Diabetes
Overview
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.
Full Title of Study: “The Effects of the DPPIV Inhibitor Sitagliptin in Cystic Fibrosis-related Diabetes”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: June 2012
Detailed Description
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.
Interventions
- Drug: Sitagliptin
- 100mg po one dose
- Drug: Placebo
- Sugar pill po one dose
Arms, Groups and Cohorts
- Active Comparator: Sitagliptin
- Placebo Comparator: Placebo
Clinical Trial Outcome Measures
Primary Measures
- Insulin release
- Time Frame: 180 minutes (during clamp)
- The study protocol is a iv-oral hyperglycemic glucose clamp. We will assess insulin release during the clamp, comparing placebo to sitagliptin.
Secondary Measures
- Incretin Response
- Time Frame: 180 minutes (during clamp)
- We will assess incretin release [glucoagon-like peptide-1 (GLP-1), gastric inhibitory polypeptide(GIP)] during the glucose clamp.
Participating in This Clinical Trial
Inclusion Criteria
- 19 years of age or older – Cystic fibrosis-related diabetes with or without fasting hyperglycemia either untreated or using only pre-prandial repaglinide or pre-prandial bolus insulin therapy Exclusion Criteria:
- Age under 19 years – Use of basal insulin therapy – Creatinine Clearance < 50 mL/min – Active cystic fibrosis exacerbation – Pregnancy – Women of child-bearing age not using effective contraception – Current or prior use of DPPIV inhibitor
Gender Eligibility: All
Minimum Age: 19 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- University of British Columbia
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Graydon Meneilly, MD, Principal Investigator, University of British Columbia
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