Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 3 Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay|
- Nutritional status evaluated as variations of Z score of BMI [ Time Frame: At recruitment time and at +3, +6, +9, +12, +15, +18 months ] [ Designated as safety issue: Yes ]
- Glucose tolerance improvement evaluated as improvement of glycometabolic parameter (glycosylated Hb) [ Time Frame: At time recruitment and +3,+6,+9+12+15+18 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2005|
|Estimated Study Completion Date:||October 2009|
|Estimated Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Insulin Glargine will be administered subcutaneously at the dosage of 0.1 U/Kg/die for three months. In case no hypoglycemic episodes occur during this period, the dosage will be increased to 0.15 U/Kg/die in occasion of the first control (T1) and will be scheduled for other three months. If even during this latter period no cases no hypoglycemic episodes occur, at the second control (T2) the dosage will be increased to the maximum of 0.2/U/Kg/die. It is generally accepted that the final dosage of glargine can be tailored to each patient, but it should be maintained between 0.1 and 0.2 U/Kg/die.
Glargine should be administered once daily in the morning and always at the same hour.
Other Name: Lantus
No Intervention: 2
Diabetes mellitus may often complicate the cystic fibrosis course, and it is usually preceded by a condition defined as glucose intolerance, during which a significant decay of patient's general conditions is observed. A slow release insulin (glargine) has become available in the market for diabetic patients: its characteristics allow for a single daily dose, and no need of repeated daily monitoring of glycemia.
In this randomized controlled clinical trial we evaluate whether the anticipated use of glargine in CF patients with glucose intolerance may prevent the worsening of nutritional status and pulmonary function.
Eligible patients who will accept to participate to this study will be randomly allocated in the group who will or will not receive glargine as additional supportive therapy. Patients will in any case continue the CF therapy prescribed by their treating physicians and their usual diet. All the patients will be evaluated every three months to assess their nutritional, pulmonary and glycometabolic status. The follow-up will continue until the 18th month after the study entry.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687466
|Pediatric Department, General Hospital,CF Center|
|Cerignola (Foggia), Italy|
|Ospedale Maggiore Policlinico, Adult CF Center|
|Pediatric Department, Federico II University, Pediatric CF Center|
|Pediatric Department G.De Cristina Hospital CF Center|
|Bambino Gesù Hospital CF Center|
|Policlinico Umberto I. CF Center|
|Principal Investigator:||Laura Minicucci, MD||G.Gaslini Institute Pediatric Department CF Center|