Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662714
• Other study ID #: F01/01 CF-RD
• Status: Completed
• Phase: Phase 3
• First received: April 17, 2008
• Last updated: July 6, 2012
• Start date: September 2001
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: Mukoviszidose Institut gGmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Diabetes Mellitus
• Fibrosis

Intervention

Drug:
• Repaglinide
oral; initial dose: 3x 0.5mg/d; 2 years
• short-acting Insulin (Actrapid)
initial dose: 3x 0.05E/kg/d, injected; 2 years

Locations

Country	Name	City	State
Austria	Universitätsklinik für Kinder- und Jugendheilkunde	Graz
Austria	Universitätsklinik für Kinder- und Jugendheilkunde	Wien
France	CRCM adultes	Lille
France	CRCM adultes, Centre Hospitalier Lyon Sud	Lyon
France	APHP, CRCM pediatrique, Hopital Cochin	Paris
France	APHP, CRCM pediatrique, Hopital Necker	Paris
France	APHP, CRCM pediatrique, Hopital Robert Debre	Paris
France	CRCM adultes, Hopital Civil	Strasbourg
Germany	Helios Klinikum Emil von Behring	Berlin
Germany	Heliosklinikum Berlin-Buch	Berlin
Germany	Prof.-Hess-Kinderklinik/ Zentralkrankenhaus	Bremen
Germany	Zentralkrankenhaus "Links der Weser"	Bremen
Germany	Universitätskinderklinik Düsseldorf	Düsseldorf
Germany	Klinik für Kinder und Jugendliche Erlangen	Erlangen
Germany	Ruhrlandklinik Essen	Essen
Germany	Universitätsklinikum Essen	Essen
Germany	Med. Klinik II, Allergologie und Pneumologie	Frankfurt
Germany	Zentrum für Kinderheilkunde Frankfurt	Frankfurt
Germany	Klinik Schillerhöhe	Gerlingen
Germany	Klinik und Poliklinik für Kinder- und Jugendmedizin	Greifswald
Germany	Altona - Klinik	Hamburg
Germany	Medizinische Hochschule Hannover, Abt. Kinderheilkunde	Hannover
Germany	Medizinische Hochschule Hannover, CF-Ambulanz f. Erwachsene	Hannover
Germany	Klikum der Universität Heidelberg, Kinderklinik	Heidelberg
Germany	Universitätsklinik für Kinder- und Jugendmedizin	Homburg
Germany	Kinderkrankenhaus Park Schönfeld	Kassel
Germany	Städtisches Krankenhaus Kiel	Kiel
Germany	Klinik und Poliklinik für allgemeine Kinderheilkunde	Köln
Germany	Universitätsklinik Mainz	Mainz
Germany	Clemenshospital	Münster
Germany	Elisabeth Kinderkrankenhaus	Oldenburg
Germany	Kinderhospital Osnabrück	Osnabrück
Germany	Kinderklinik Dritter Orden, Sozialpädiatrisches Zentrum	Passau
Germany	Universitätsklinik für Kinder- und Jugendmedizin	Tübingen
Germany	Julius-Maximilians Universität, Kinderpoliklinik	Würzburg
Italy	Centro Fibrosi Cistica	Verona

Sponsors (4)

Lead Sponsor	Collaborator
Mukoviszidose Institut gGmbH	Assistance Publique - Hôpitaux de Paris, Mucoviscidose-ABCF2, Novo Nordisk A/S

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		2 years	No