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Sitagliptin in Cystic Fibrosis-Related Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01257464
Recruitment Status : Terminated (Lack of recruitment)
First Posted : December 9, 2010
Last Update Posted : March 6, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Sitagliptin Drug: Placebo Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of the DPPIV Inhibitor Sitagliptin in Cystic Fibrosis-related Diabetes
Study Start Date : September 2010
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257464


Locations
Canada, British Columbia
University of British Columbia Gerontology & Diabetes Reserach Centre (ViTALITY)
Vancouver, British Columbia, Canada, V5Z 1L8
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Graydon Meneilly, MD University of British Columbia
More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01257464     History of Changes
Other Study ID Numbers: H08-02131
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: March 6, 2014
Last Verified: March 2014

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

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