Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis

NCT01721382 | Completed Phase 1

• 1 other identifier: CFRD-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will be conducted in adolescents with cystic fibrosis (CF) without diabetes but with abnormal glucose tolerance, and will assess the effects of sitagliptin on glucose regulation. An oral glucose tolerance test (OGTT) and a mixed meal tolerance test (MMTT), will be performed at baseline and again \~4 weeks after treatment with study drug. We will also look at blood sugars throughout the day using a continuous glucose monitor (CGM) before each time the MMTT/OGTT are performed. Several hormones that may affect the way the body regulates blood sugars will be measured in blood when the OGTT and MMTT are done. We will assess the effect this medicine has on blood sugars (using CGM) and the effect the medicine has on the hormones measured during the OGTT and MMTT.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; CF; CFRD; sitagliptin; incretins; GLP1; GIP; beta cell function; adolescents

Outcome Measures

Primary Outcomes (4)

• Response to sitagliptin

  Baseline and stimulated C-peptide levels (using mixed meal tolerance test) before and after treatment with sitagliptin.

  Change from baseline to ~4 weeks of study drug

• Response to sitagliptin

  Change in glycemic variability using continuous glucose monitoring data before and after treatment with dipeptidyl peptidase-4 inhibitor.

  Change from baseline to ~4 weeks of study drug

• Response to sitagliptin

  Change in incretins concentrations (glucagon like peptide 1; glucose-dependent insulinotropic polypeptide) in response to study drug.

  Change from baseline to ~4 weeks of study drug

• Response to sitagliptin

  Change in incretin (glucagon like peptide 1; glucose-dependent insulinotropic polypeptide) concentrations in response to study drug.

  Change from baseline to ~4 weeks of study drug

Secondary Outcomes (2)

• Beta-cell function

  Change from baseline to ~4 weeks of study drug

• Continuous glucose monitoring (CGM)

  change from baseline to ~4 weeks of study drug

Study Arms (1)

Sitagliptin

EXPERIMENTAL

Treatment with sitagliptin

Drug: Sitagliptin

Interventions

Sitagliptin DRUG

Sitagliptin

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with CF between 13 and \<21 yrs old
• Known impaired or indeterminate glucose tolerance (based on a prior OGTT)
• No history of CFRD

You may not qualify if:

• Insulin use in the last two months
• Acute pulmonary exacerbation / oral corticosteroid use in the last 6 weeks
• History of pancreatitis in the last 12 months
• Skin rashes or conditions that may affect CGM placement and wear
• Pregnancy or intent on becoming pregnant
• Patients on growth hormone therapy
• Renal insufficiency with creatinine clearance \<50 ml/min (based on Schwartz formula)

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Larry A Fox, MD

  Nemours Children's Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Endocrinologist

Study Record Dates

• First Submitted: October 26, 2012
• First Posted: November 5, 2012
• Study Start: November 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 14, 2016

Record last verified: 2016-06

Locations

US (1)