treatment with insulin in patients with cystic fibrosis without diabetes

• Register: EUCTR
• Last refreshed on: 17 June 2013
• Main ID: EUCTR2011-001916-69-NL
• Date of registration: 07/02/2012
• Prospective Registration: Yes
• Primary sponsor: HagaZiekenhuis, pulmonary department
• Public title: treatment with insulin in patients with cystic fibrosis without diabetes
• Scientific title: insulin therapy in non-diabetic adults with cystic fibrosis - insulin in CF without CFRD
• Date of first enrolment: 22/05/2012
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001916-69
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Netherlands

Contacts

• Name: microbiologist, Hagaziekenhuis
• Affiliation: Dhr. R. Brimicombe

• Name: microbiologist, Hagaziekenhuis
• Affiliation: Dhr. R. Brimicombe

Key inclusion & exclusion criteria

Inclusion criteria:
Patients>18 years diagnosed with cystic fibrosis, a normal glucose tolerance test, exocrine pancreatic insufficiency.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
pregnancy, pregnancy wish, lactation, history of organ transplantation, high urgency status on waiting list for transplantation, use of systemic corticosteroids within one mont before of during the study period, malignancy, distal intestinal obstruction syndrome (DIOS) or pulmonary exacerbation with hospital admission one month before or during the study period, use of appetite stimulants.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

cystic fibrosis patients without cystic fibrosis related diabetes

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Trade Name: Lantus 100 units/ml solution for injection in a cartridge
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: investigate the effect of low dose insulin therapy on nutritional status en body weight,.

Primary end point(s): body weight, body mass index

Secondary Objective: investigate the effect of insulin on pulmonary function and quality of life.

Timepoint(s) of evaluation of this end point: end of study period ( 24 weeks)

Secondary Outcome(s)

Secondary end point(s): pre-albumin levels, vitamin status, pulmonary function, number of exacerbations, antibiotic use, Fat free mass index. ESR, CRP, leucocytes, quality of life on a validated quality of life questionnaire for CF.

Timepoint(s) of evaluation of this end point: end of study period ( 24 weeks)

Secondary ID(s)

CF201101

Source(s) of Monetary Support

NCFS