| November 12, 2003 |
| December 20, 2007 |
| June 2001 |
| December 2007 (final data collection date for primary outcome measure) |
| 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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00072904 on ClinicalTrials.gov Archive Site |
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| Diabetes Therapy to Improve BMI and Lung Function in CF |
| Diabetes Therapy to Improve BMI and Lung Function in CF |
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). |
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. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
- Cystic Fibrosis
- Diabetes Mellitus
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- Drug: Insulin Asparte
- Drug: Repaglinide
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| Placebo Comparator: Placebo take half tab with meals tid |
| Moran A, Pekow P, Grover P, Zorn M, Slovis B, Pilewski J, Tullis E, Liou TG, Allen H; Cystic Fibrosis Related Diabetes Therapy Study Group. Insulin therapy to improve BMI in cystic fibrosis-related diabetes without fasting hyperglycemia: results of the cystic fibrosis related diabetes therapy trial. Diabetes Care. 2009 Oct;32(10):1783-8. Epub 2009 Jul 10. |
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| Completed |
| 108 |
| December 2007 |
| December 2007 (final data collection date for primary outcome measure) |
- Diabetic glucose pattern by oral glucose tolerance test (OGTT) of >200 at 120 min. (stable and healthy at time of OGTT)
- Fasting glucose levels <126.
- Weight stable within 5% in previous 3 months.
- Free from illness for two months.
- Male and female 16 and older, who are done growing
- Willing to come in for visits every 3 months.
- Patients receiving infrequent short bursts of systemic glucocorticoids may be considered for the study inclusion if: a. they have not received systemic glucocorticoids steroids for at least one month, b. they did not receive the steroids for more than 14 consecutive days or 28 days total in six months
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| Both |
| 16 Years and older |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada |
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| NCT00072904 |
| Antoinette Moran, University Of Minnesota |
| 58356DK |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
- Cystic Fibrosis Foundation
- Novo Nordisk
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| Principal Investigator: |
Antoinette Moran, MD |
University of Minnesota |
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| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| December 2007 |
