Sitagliptin in Cystic Fibrosis-Related Diabetes

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01257464

Enrollment

Registered

2010-12-09

Start date

2010-09-30

Completion date

2012-06-30

Last updated

2014-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

CFRD, sitagliptin, cystic fibrosis-related diabetes, incretins, hyperglycemia, GIP, GLP-1

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.

Interventions

DRUGSitagliptin

100mg po one dose

DRUGPlacebo

Sugar pill po one dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026