Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis

Completed · Phase 1

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID: NCT01721382
Run by: Nemours Children's Clinic
People needed: 6
Starts: 2012-11-01
Expected to finish: 2016-06-01
Last updated by the study team: 2016-06-14

Who can join

Age: 13 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

Nemours Children's Clinic — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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