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Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis

Open Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00662714
Enrollment
73
Registered
2008-04-21
Start date
2001-09-30
Completion date
2011-12-31
Last updated
2012-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Diabetes Mellitus

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

DRUGRepaglinide

oral; initial dose: 3x 0.5mg/d; 2 years

DRUGshort-acting Insulin (Actrapid)

initial dose: 3x 0.05E/kg/d, injected; 2 years

Sponsors

Novo Nordisk A/S
CollaboratorINDUSTRY
Mucoviscidose-ABCF2
CollaboratorUNKNOWN
Assistance Publique - Hôpitaux de Paris
CollaboratorOTHER
Mukoviszidose Institut gGmbH
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No

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

MeasureTime frame
HbA1c2 years

Countries

Austria, France, Germany, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026