title: Slow-release insulin in cystic fibrosis patients with glucose intolerance: a randomized clinical trial.
abstract: BACKGROUND
  Early stages of glucose metabolism impairment are a period at risk in the long-term prognosis of cystic fibrosis (CF). Slow-release synthetic insulin glargine can be a therapeutic tool in this metabolic condition.
  
  
  METHODS
  In this phase 3 multicenter, controlled, two-arm, randomized clinical study, glargine was administered up to a dosage of 0.15 U/kg/die for a period of 18 months. Primary endpoint was the improvement of nutritional status [body mass index (BMI) Z score], while glucose tolerance [hemoglobin A1c (HbA1C) and respiratory function (FEV1 predicted] improvement were the secondary endpoints.
  
  
  RESULTS
  Thirty-four subjects (18 in the glargine arm and 16 in the control arm) were evaluated. Adherence to insulin treatment was excellent. No significant adverse events were reported. There were no significant differences in BMI, HbA1C and FEV1 values between the two groups nor within groups, except for HbA1C improvement in the glargine arm at month +18 (p = 0.04).
  
  
  CONCLUSIONS
  Glargine treatment was well accepted and tolerated. No real efficacy in improving clinical and glycometabolic conditions was demonstrated. Further studies are necessary to test glargine at higher dosage and for a longer follow-up period.
authors: Pediatric Department, CF Center, G. Gaslini Children Hospital, 16147 Genova, Italy. lauraminicucci@ospedale-gaslini.ge.it
authors: Laura
authors: L
authors: Minicucci
authors: Maria
authors: M
authors: Haupt
authors: Rosaria
authors: R
authors: Casciaro
authors: Alessandra
authors: A
authors: De Alessandri
authors: Francesca
authors: F
authors: Bagnasco
authors: Vincenzina
authors: V
authors: Lucidi
authors: Sara
authors: S
authors: Notarnicola
authors: Renata
authors: R
authors: Lorini
authors: Serenella
authors: S
authors: Bertasi
authors: Valeria
authors: V
authors: Raia
authors: Pietro
authors: P
authors: Cialdella
authors: Riccardo
authors: R
authors: Haupt
mesh_terms: D000293:Adolescent; D000328:Adult; D015992:Body Mass Index; D002648:Child; D003550:Cystic Fibrosis / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D018149:Glucose Intolerance / Q000188:drug therapy*; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting / Q000627:therapeutic use*; D008168:Lung / Q000187:drug effects / Q000502:physiology; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D055815:Young Adult
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting; C517652:hemoglobin A1c protein, human