Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231192
Status:
WITHDRAWN
Last Update Posted:
2015-03-12
First Post:
2005-10-03
Brief Title:
Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes
Status:
WITHDRAWN
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit any subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Cystic Fibrosis Foundation | None | None | None |