Sitagliptin in Cystic Fibrosis-Related Diabetes

NCT ID: NCT01257464

Last Updated: 2014-03-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-06-30

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.

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sitagliptin

Group Type: ACTIVE_COMPARATOR

Sitagliptin

Intervention Type: DRUG

100mg po one dose

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sugar pill po one dose

Interventions

Sitagliptin

100mg po one dose

Intervention Type: DRUG

Placebo

Sugar pill po one dose

Intervention Type: DRUG

Other Intervention Names

Januvia, MK-0431, Dipeptidyl peptidase IV inhibitor (DPP-4 inhibitor)

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Graydon Meneilly, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia Gerontology & Diabetes Reserach Centre (ViTALITY)

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H08-02131

Identifier Type: -

Identifier Source: org_study_id