Cystic Fibrosis, Diabetes Mellitus
Conditions
Brief summary
Is oral therapy with Repaglinide equivalent to insulin therapy with three daily injections with respect to blood glucose control, weight and pulmonary function over 2 years in patients with cystic fibrosis and secondary diabetes mellitus? That is the question examined in the phase III trial.
Detailed description
Diabetes mellitus may be present in patients with cystic fibrosis (mucoviscidosis) starting in the second decade of life. The prevalence increases rapidly with increasing age. As life-expectancy increases in CF, CF-related diabetes will be diagnosed more frequently in the future. Negative consequences of secondary diabetes in cystic fibrosis include: * Catabolic metabolism * Weight loss * More frequent / more severe infections * Deterioration of pulmonary function * Reduced life-expectancy * Diabetic micro vascular complications (retinopathy, nephropathy, neuropathy) Up to date, no data are available to answer the question, whether secondary diabetes in CF should always be treated by insulin therapy. Several centres report the successful management of CF-related diabetes using oral anti-diabetic drugs at least for some years. Oral therapies would be less invasive for a patient group which is highly traumatised by a very demanding therapy (multiple drugs including antibiotics, pancreas enzymes, bronchodilators, mucolysis, in addition to physiotherapy, regular inpatient iv-antibiotic therapy etc, finally lung transplants in a subgroup of patients).
Interventions
oral; initial dose: 3x 0.5mg/d; 2 years
initial dose: 3x 0.05E/kg/d, injected; 2 years
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion Criteria for the Screening: * Diagnosed cystic fibrosis * Age 10 years and older Inclusion Criteria for the therapeutic part of the study: * Newly diagnosed Diabetes mellitus in the screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | 2 years |
Countries
Austria, France, Germany, Italy