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Sitagliptin in Cystic Fibrosis-Related Diabetes

This study is currently recruiting participants.
Verified December 2011 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01257464
First received: December 2, 2010
Last updated: December 6, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
 Drug: Sitagliptin
Drug: Placebo
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
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)
Arms Assigned Interventions
Active Comparator: Sitagliptin Drug: Sitagliptin
100mg po one dose
Other Name: Januvia, MK-0431, Dipeptidyl peptidase IV inhibitor (DPP-4 inhibitor)
Placebo Comparator: Placebo Drug: Placebo
Sugar pill po one dose

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257464

Contacts
Contact: Sara G Stafford, MDCM sara.stafford@gmail.com
Contact: Chris Lockhart 604-875-4111 ext 68535 lockhart@interchange.ubc.ca

Locations
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     lockhart@interchange.ubc.ca    
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Graydon Meneilly, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01257464     History of Changes
Other Study ID Numbers: H08-02131
Study First Received: December 2, 2010
Last Updated: December 6, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
CFRD
sitagliptin
cystic fibrosis-related diabetes
incretins
 hyperglycemia
GIP
GLP-1

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
 Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013