Sitagliptin in Cystic Fibrosis-Related Diabetes

Cystic Fibrosis Clinical Trial

Official title:

The Effects of the DPPIV Inhibitor Sitagliptin in Cystic Fibrosis-related Diabetes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01257464
• Other study ID #: H08-02131
• Status: Terminated
• Phase: Phase 2
• First received: December 2, 2010
• Last updated: March 5, 2014
• Start date: September 2010
• Est. completion date: June 2012

Study information

• Verified date: March 2014
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Sitagliptin
100mg po one dose
• Placebo
Sugar pill po one dose

Locations

Country	Name	City	State
Canada	University of British Columbia Gerontology & Diabetes Reserach Centre (ViTALITY)	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin release	The study protocol is a iv-oral hyperglycemic glucose clamp. We will assess insulin release during the clamp, comparing placebo to sitagliptin.	180 minutes (during clamp)	No
Secondary	Incretin Response	We will assess incretin release [glucoagon-like peptide-1 (GLP-1), gastric inhibitory polypeptide(GIP)] during the glucose clamp.	180 minutes (during clamp)	No