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Sponsored by: |
Children's Hospital of Philadelphia |
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Information provided by: | Children's Hospital of Philadelphia |
ClinicalTrials.gov Identifier: | NCT00231192 |
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.
Condition | Intervention |
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Diabetes |
Drug: Repaglinide and Insulin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes |
Enrollment: | 0 |
Study Start Date: | October 2005 |
Study Completion Date: | August 2007 |
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.
Ages Eligible for Study: | 12 Years to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Cystic Fibrosis, Blood glucose concerning for diabetes -
Exclusion Criteria:
Known Cystic Fibrosis-Related Diabetes, Liver Disease, FEV1<40%
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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 |
Study ID Numbers: | 2005-8-4323, Cystic Fibrosis Foundation |
Study First Received: | October 3, 2005 |
Last Updated: | November 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00231192 |
Health Authority: | United States: Food and Drug Administration |
Diabetes Adolescents Cystic Fibrosis Insulin Repaglinide |
Metabolic Diseases Fibrosis Diabetes Mellitus Endocrine System Diseases Insulin Repaglinide Digestive System Diseases Cystic Fibrosis Respiratory Tract Diseases |
Genetic Diseases, Inborn Lung Diseases Pancreatic Diseases Infant, Newborn, Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Cystic fibrosis |
Hypoglycemic Agents Pathologic Processes Physiological Effects of Drugs Pharmacologic Actions |