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. Identifier: NCT01257464
Recruitment Status : Terminated (Lack of recruitment)
First Posted : December 9, 2010
Last Update Posted : March 6, 2014
Information provided by (Responsible Party):
University of British Columbia

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 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
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01257464

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
Principal Investigator: Graydon Meneilly, MD University of British Columbia

Responsible Party: University of British Columbia 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:
cystic fibrosis-related diabetes

Additional relevant MeSH terms:
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
Hormones, Hormone Substitutes, and Hormone Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action