Trial | NCT00662714  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    73
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.
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).
Study Started
Sep 30
2001
Primary Completion
Dec 31
2011
Study Completion
Dec 31
2011
Last Update
Jul 10
2012
Estimate

Drug Repaglinide

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

Drug short-acting Insulin (Actrapid)

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

  • Other names: Actrapid

1 Experimental

Repaglinide; oral

2 Active Comparator

short-acting Insulin (Actrapid)

Criteria 

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

Exclusion Criteria:

Exclusion Criteria for Screening:

Diabetic keto-acidosis (blood glucose > 350 mg/dl and arterial pH < 7.25)
Already treated Diabetes mellitus by oral antidiabetic medication or insulin

Exclusion Criteria for the therapeutic part of the study:

Systemic steroid therapy during the last 3 months
Transplantation (status post TX or on the waiting list for TX)
Beginning pulmonary insufficiency, FEV1 < 35% at pulmonary function test in stable condition
Pregnancy
Already diagnosed and treated diabetes mellitus
Patients with diabetic keto-acidosis (blood glucose > 350 mg/dl and arterial pH < 7.25) with or without diabetic coma
Severe liver insufficiency (chronic hepatitis B, AST or ALT twice the upper limit of normal, Quick's value < 70% which is a contraindication to use Repaglinide)
Treatment with an indispensable important drug which contraindicates Repaglinide
PEG/ gastric tube/ total parenteral alimentation for more than 4 weeks during the study
CF-patients with type 1 diabetes
Not patient's consent to randomisation and therapeutic trial
Participation on other medical trial
No Results Posted