Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721382
• Other study ID #: CFRD-01
• Status: Completed
• Phase: Phase 1
• First received: October 26, 2012
• Last updated: June 10, 2016
• Start date: November 2012
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 20 Years

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Sitagliptin

Locations

Country	Name	City	State
United States	Nemours Children's Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Beta-cell function	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.	Change from baseline to ~4 weeks of study drug	No
Secondary	Continuous glucose monitoring (CGM)	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.	change from baseline to ~4 weeks of study drug	No