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| Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Cystic Fibrosis Foundation Novo Nordisk |
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00072904 |
Purpose
To recruit 150 adult patients with cystic fibrosis related diabetes (CFRD) without fasting hyperglycemia for a multi-center, twelve month, placebo-controlled intervention trial testing the ability of insulin or repaglinide to improve body mass index (BMI) and stabilize pulmonary function in cystic fibrosis (CF).
| Condition | Intervention | Phase |
|
Cystic Fibrosis Diabetes Mellitus |
Drug: Insulin Asparte Drug: Repaglinide |
Phase III |
| Genetics Home Reference related topics: | cystic fibrosis |
| MedlinePlus related topics: | Cystic Fibrosis Diabetes |
| ChemIDplus related topics: | Insulin AG-EE 388 ZW |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Diabetes Therapy to Improve BMI and Lung Function in CF |
| Enrollment: | 108 |
| Study Start Date: | June 2001 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
III: Placebo Comparator
Placebo take half tab with meals tid
|
Drug: Insulin Asparte
Insulin asparte given 0.5 units per carb per meal
Drug: Repaglinide
0.5mg tab with meals tid
|
The primary objective of this research is to determine whether treatment with either insulin or an oral diabetes agent that increases endogenous insulin secretion will improve BMI and pulmonary function in cystic fibrosis patients who have diabetes without fasting hyperglycemia.
Eligibility
| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Contacts and Locations| United States, California | |||||
| Stanford University | |||||
| Palo Alto, California, United States, 94304 | |||||
| United States, Massachusetts | |||||
| Baystate Medical Center | |||||
| Springfield, Massachusetts, United States, 01199 | |||||
| United States, Minnesota | |||||
| University of Minnesota Medical Center | |||||
| Minneapolis, Minnesota, United States, 55455 | |||||
| United States, Pennsylvania | |||||
| Children's Hospital of Pittsburgh | |||||
| Pittsburgh, Pennsylvania, United States, 15213-2583 | |||||
| United States, Tennessee | |||||
| Vanderbilt University Medical Center | |||||
| Nashville, Tennessee, United States, 37232-2650 | |||||
| United States, Utah | |||||
| University of Utah | |||||
| Salt Lake City, Utah, United States, 84132-4701 | |||||
| Canada, Ontario | |||||
| St. Michael's Hospital | |||||
| Toronto, Ontario, Canada, M5B 1W8 | |||||
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Cystic Fibrosis Foundation |
| Novo Nordisk |
| Principal Investigator: | Antoinette Moran, MD | University of Minnesota |
More Information
| Responsible Party: | University Of Minnesota ( Antoinette Moran ) |
| Study ID Numbers: | 58356DK |
| First Received: | November 12, 2003 |
| Last Updated: | December 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00072904 |
| Health Authority: | United States: Food and Drug Administration |
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