CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
placebo +1 moredrug
Likely dose
repaglinide 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00763412
NCT00763412N/ACompleted
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Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis

Arbelaez, Ana Maria·interventional·Posted Oct 1, 2008·Updated Jun 5, 2017

In Brief

A clinical study evaluating placebo and repaglinide for Cystic Fibrosis Related Diabetes and Pancreatic Insufficiency. Completed, enrolled 31 participants across 1 site.

Detailed Summary

The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis Related Diabetes, Pancreatic Insufficiency
CountriesUnited States
CollaboratorsWashington University School of Medicine, National Institutes of Health (NIH), Novo Nordisk A/S, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 1, 2008
Enrollment StartNov 1, 2006
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 17.8 years ago

Interventions

placebodrug

CF pancreatic insufficient patients with impaired glucose tolerance (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH) by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.

repaglinidedrug

CF pancreatic insufficient patients with impaired glucose tolerance (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH) by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.