Sitagliptin in Cystic Fibrosis-Related Diabetes

Phase 2TerminatedNCT01257464

University of British Columbia3 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cystic Fibrosis

Interventions

SitagliptinDRUG

100mg po one dose

PlaceboDRUG

Sugar pill po one dose

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Insulin release

The study protocol is a iv-oral hyperglycemic glucose clamp. We will assess insulin release during the clamp, comparing placebo to sitagliptin.

Time frame: 180 minutes (during clamp)

Secondary Outcomes

Incretin Response

We will assess incretin release \[glucoagon-like peptide-1 (GLP-1), gastric inhibitory polypeptide(GIP)\] during the glucose clamp.

Time frame: 180 minutes (during clamp)

Data from ClinicalTrials.gov

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