Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Cystic Fibrosis, Diabetes Mellitus

Intervention / Treatment
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* Drug: Repaglinide
* Drug: short-acting Insulin (Actrapid)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Repaglinide; oral | Drug: Repaglinide<br>* oral; initial dose: 3x 0.5mg/d; 2 years<br>|
| Active Comparator: 2<br>short-acting Insulin (Actrapid) | Drug: short-acting Insulin (Actrapid)<br>* initial dose: 3x 0.05E/kg/d, injected; 2 years<br>* Other names: Actrapid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 2 years |