Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Nemours Children's Clinic
Sponsor:
Information provided by (Responsible Party):
Larry Fox, Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT01721382
First received: October 26, 2012
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Drug: Sitagliptin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis.

Resource links provided by NLM:


Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:
  • Response to sitagliptin [ Time Frame: Change from baseline to ~4 weeks of study drug ] [ Designated as safety issue: No ]
    Baseline and stimulated C-peptide levels (using mixed meal tolerance test) before and after treatment with sitagliptin.

  • Response to sitagliptin [ Time Frame: Change from baseline to ~4 weeks of study drug ] [ Designated as safety issue: No ]
    Change in glycemic variability using continuous glucose monitoring data before and after treatment with dipeptidyl peptidase-4 inhibitor.

  • Response to sitagliptin [ Time Frame: Change from baseline to ~4 weeks of study drug ] [ Designated as safety issue: No ]
    Change in incretins concentrations (glucagon like peptide 1; glucose-dependent insulinotropic polypeptide) in response to study drug.

  • Response to sitagliptin [ Time Frame: Change from baseline to ~4 weeks of study drug ] [ Designated as safety issue: No ]
    Change in incretin (glucagon like peptide 1; glucose-dependent insulinotropic polypeptide) concentrations in response to study drug.


Secondary Outcome Measures:
  • Beta-cell function [ Time Frame: Change from baseline to ~4 weeks of study drug ] [ Designated as safety issue: No ]
    Beta-cell function will be measured using mixed meal tolerance tests (MMTT) and oral glucose tolerance tests (OGTT), assessing maximum concentration and area under the curve (AUC) of glucose, insulin and c-peptide for both OGTT and MMTT.

  • Continuous glucose monitoring (CGM) [ Time Frame: change from baseline to ~4 weeks of study drug ] [ Designated as safety issue: No ]
    Baseline and post-treatment changes in glycemic variability using CGM, including mean amplitude of glycemic excursion (MAGE), peak post-prandial blood sugars, and glucose area under the curve.


Estimated Enrollment: 10
Study Start Date: November 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin
Treatment with sitagliptin
Drug: Sitagliptin

  Eligibility

Ages Eligible for Study:   13 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721382

Contacts
Contact: Larry A. Fox, MD 904-697-3674 lfox@nemours.org
Contact: Ranjana Sarma, MD 904-697-3145 rsarma@nemours.org

Locations
United States, Florida
Nemours Children's Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Ranjana Sarma, MD    904-697-3145    rsarma@nemours.org   
Principal Investigator: Larry A Fox, MD         
Sponsors and Collaborators
Nemours Children's Clinic
Investigators
Principal Investigator: Larry A Fox, MD Nemours Children's Clinic
  More Information

No publications provided

Responsible Party: Larry Fox, Pediatric Endocrinologist, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT01721382     History of Changes
Other Study ID Numbers: CFRD-01
Study First Received: October 26, 2012
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Nemours Children's Clinic:
cystic fibrosis
CF
CFRD
sitagliptin
incretins
GLP1
GIP
beta cell function
adolescents

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014