This trial is active, not recruiting.

Conditions cystic fibrosis, glucose intolerance
Treatment insulin
Phase phase 3
Sponsor Fondazione per la ricerca sulla Fibrosi Cistica
Start date August 2005
End date October 2009
Trial size 70 participants
Trial identifier NCT00687466, FFC #21/2006, IGG-FC-G-01, eudraCT number 2005-002135-27


The purpose of this study is to evaluate whether the anticipated use of glargine in CF patients with glucose intolerance may prevent the worsening of nutritional status and pulmonary function.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Insulin yes
insulin Lantus
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.
(No Intervention)
Insulin no

Primary Outcomes

Nutritional status evaluated as variations of Z score of BMI
time frame: At recruitment time and at +3, +6, +9, +12, +15, +18 months

Secondary Outcomes

Glucose tolerance improvement evaluated as improvement of glycometabolic parameter (glycosylated Hb)
time frame: At time recruitment and +3,+6,+9+12+15+18 months

Eligibility Criteria

Male or female participants from 10 years up to 70 years old.

Inclusion Criteria: - Ascertained diagnosis of CF - Age ≥ 10 years - Glucide intolerance: 2 pathologic OGTT ( at 120' glucose value: >140 mg% and <200 mg%) at 2-6 months' interval between each other - At least one of the following conditions: - BMI (body mass index) < 10th centile for age and sex (according to Rolland Cachera 1991) - Loss of one BMI centile class for age and sex in the last year (according to Rolland Cachera 1991) - FEV1 ≤ 80% of predicted - FEV1 decrease ≥ 10% in the last year Exclusion Criteria: - Specific contraindications for the use of glargine

Additional Information

Official title Phase 3 Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay
Principal investigator Laura Minicucci, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2009.
Information provided to ClinicalTrials.gov by Fondazione per la ricerca sulla Fibrosi Cistica.