Sitagliptin in Cystic Fibrosis-Related Diabetes

Phase 2

Terminated

• Conditions: Cystic Fibrosis
• Interventions: Drug: Placebo; Drug: Sitagliptin

• Registration Number: NCT01257464
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-05
• Last Update Posted: 2014-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Sitagliptin	Sitagliptin	-

Primary Outcome Measures

Name	Time	Method
Insulin release	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

Name	Time	Method
Incretin Response	180 minutes (during clamp)	We will assess incretin release \[glucoagon-like peptide-1 (GLP-1), gastric inhibitory polypeptide(GIP)\] during the glucose clamp.

Trial Locations

Locations (1)

University of British Columbia Gerontology & Diabetes Reserach Centre (ViTALITY); 🇨🇦 Vancouver, British Columbia, Canada