One Year Glargine Treatment in CFRD Children and Adolescents
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ClinicalTrials.gov Identifier: NCT00483769 |
Recruitment Status :
Completed
First Posted : June 7, 2007
Last Update Posted : June 7, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cystic Fibrosis Glucose Metabolism Disorders | Drug: Glargine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | One-Year Glargine-Treatment Can Ameliorate Clinical Features in Cystic Fibrosis Children and Adolescents With Glucose Derangements |
Study Start Date : | February 2006 |
Actual Study Completion Date : | January 2007 |

- Reduction of decline in pulmonary function measured as FEV1 [ Time Frame: One year ]
- Improvement of: Body Mass Index, Number of Lung Infections, HbA1c [ Time Frame: One Year ]

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Ages Eligible for Study: | 3 Years to 20 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients affected by Cystic Fibrosis who had shown glucose derangements.
Exclusion Criteria:
- Patients with/without Cystic Fibrosis without glucose derangements.

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): NCT00483769
Italy | |
Deptm of Pediatrics Regional Cystic Fibrosis Center- University of Naples - Federico II | |
Naples, Italy, 80131 |
Study Director: | Adriana Franzese, Dr | Federico II University | |
Principal Investigator: | Adriana Franzese, Dr | University of Naples Dept of Pediatrics Regional Cystic Fibrosis Center | |
Principal Investigator: | Adriana Franzese, Dr | Federico II University |
Publications of Results:
ClinicalTrials.gov Identifier: | NCT00483769 |
Other Study ID Numbers: |
234-234-234-234-234 |
First Posted: | June 7, 2007 Key Record Dates |
Last Update Posted: | June 7, 2007 |
Last Verified: | February 2007 |
Cystis Fibrosis Glucose intolerance Glargine FEV1% |
Cystic Fibrosis Metabolic Diseases Glucose Metabolism Disorders Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Insulin Glargine Hypoglycemic Agents Physiological Effects of Drugs |