Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes
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|ClinicalTrials.gov Identifier: NCT00231192|
Recruitment Status : Withdrawn (Unable to recruit any subjects)
First Posted : October 4, 2005
Last Update Posted : March 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Drug: Repaglinide and Insulin||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes|
|Study Start Date :||October 2005|
|Actual Study Completion Date :||August 2007|
U.S. FDA Resources
- blood glucose
- insulin excursion during oral glucose tolerance test
- fasting blood glucose
- 2-hour post-prandial blood glucose
- hemoglobin A1C
- serum fructosamine
- body mass index
- lean body mass
- pulmonary function
- quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00231192
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104-4399|
|Principal Investigator:||Andrea Kelly, MD||Children's Hospital of Philadelphia|