Sitagliptin in Cystic Fibrosis-Related Diabetes

University of British Columbia

Status and phase: Terminated; Phase 2

Conditions: Cystic Fibrosis

Treatments: Drug: Sitagliptin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01257464

H08-02131

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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3 participants in 2 patient groups, including a placebo group

Sitagliptin

Active Comparator group

Treatment:

Drug: Sitagliptin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo