Status:
COMPLETED
Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis
Lead Sponsor:
Mukoviszidose Institut gGmbH
Collaborating Sponsors:
Novo Nordisk A/S
Mucoviscidose-ABCF2
Conditions:
Cystic Fibrosis
Diabetes Mellitus
Eligibility:
All Genders
10+ years
Phase:
PHASE3
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 fib...
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 incre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00662714
Start Date
September 1 2001
End Date
December 1 2011
Last Update
July 10 2012
Active Locations (36)
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1
Universitätsklinik für Kinder- und Jugendheilkunde
Graz, Austria, 8036
2
Universitätsklinik für Kinder- und Jugendheilkunde
Vienna, Austria, 1090
3
CRCM adultes
Lille, France, 59037
4
CRCM adultes, Centre Hospitalier Lyon Sud
Lyon, France, 69495