Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes

Not Applicable

Withdrawn

• Conditions: Diabetes

• Registration Number: NCT00231192
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

This study will test the hypothesis that oral repaglinide is equivalent to insulin in the treatment of new-onset CFRD in adolescents. In addition, successful treatment of CFRD with repaglinide will improve nutritional status, ameliorate declines in pulmonary function, and will not have a negative impact upon quality of life.

Detailed Description

This study will test the hypothesis that oral repaglinide is equivalent to insulin in the treatment of new-onset CFRD. This hypothesis will be tested using the following aims:

Specific Aim 1: To determine the effect of three months of repaglinide and insulin treatment upon blood glucose (BG) and insulin excursion during an oral glucose tolerance test.

Specific Aim 2: To determine the effect of three months of repaglinide and insulin treatment upon BG as measured by continuous glucose monitoring, fasting BG, 2-hour post-prandial BG, hemoglobin A1C, and serum fructosamine.

Secondary Aim 1: To determine the effect of three months of repaglinide and insulin treatment upon weight, body mass index, and lean body mass in adolescents with new-onset CFRD.

Secondary Aim 2: To determine the effect of three months of repaglinide and insulin treatment upon pulmonary function in adolescents with new-onset CFRD.

Secondary Aim 3: To determine the effect of three months of repaglinide and insulin treatment upon quality of life in new-onset CFRD.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-03
• Study First Submitted QC: 2005-10-03
• Study First Posted: 2005-10-04
• Study Completion: 2007-08
• Status Verified: 2007-11
• Last Update Submitted: 2015-03-11
• Last Update Posted: 2015-03-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Cystic Fibrosis, Blood glucose concerning for diabetes -

Read More

Exclusion Criteria

Known Cystic Fibrosis-Related Diabetes, Liver Disease, FEV1<40%

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
blood glucose
insulin excursion during oral glucose tolerance test
fasting blood glucose
2-hour post-prandial blood glucose
hemoglobin A1C
serum fructosamine

Secondary Outcome Measures

Name	Time	Method
weight
pulmonary function
quality of life
body mass index
lean body mass

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States