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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