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| Sponsored by: |
Children's Hospital of Philadelphia |
|---|---|
| Information provided by: | Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT00231192 |
Purpose
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 |
|---|---|
|
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.
Eligibility| 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%
-
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | 2005-8-4323, Cystic Fibrosis Foundation |
| Study First Received: | October 3, 2005 |
| Last Updated: | November 13, 2007 |
| ClinicalTrials.gov Identifier: | NCT00231192 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Diabetes Adolescents Cystic Fibrosis Insulin Repaglinide |
|
Metabolic Diseases Fibrosis Diabetes Mellitus Endocrine System Diseases Insulin Repaglinide Hypoglycemic Agents Digestive System Diseases Cystic Fibrosis |
Respiratory Tract Diseases Genetic Diseases, Inborn Lung Diseases Pancreatic Diseases Infant, Newborn, Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
|
Metabolic Diseases Fibrosis Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Pharmacologic Actions Insulin Repaglinide Hypoglycemic Agents |
Digestive System Diseases Pathologic Processes Cystic Fibrosis Respiratory Tract Diseases Genetic Diseases, Inborn Lung Diseases Pancreatic Diseases Infant, Newborn, Diseases Glucose Metabolism Disorders |
