Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis - Full Text View

Sponsors and Collaborators:	Mukoviszidose Institut gGmbH Novo Nordisk Mucoviscidose-ABCF2
Information provided by:	Mukoviszidose Institut gGmbH
ClinicalTrials.gov Identifier:	NCT00662714

Purpose

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.

Condition	Intervention	Phase
Cystic Fibrosis Diabetes Mellitus	Drug: Repaglinide Drug: short-acting Insulin (Actrapid)	Phase III

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis Diabetes

Drug Information available for: Insulin AG-EE 388 ZW

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Open Randomised Prospective Comparative Multi-Centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus

Further study details as provided by Mukoviszidose Institut gGmbH:

Primary Outcome Measures:

HbA1c [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	74
Study Start Date:	September 2001
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Repaglinide; oral	Drug: Repaglinide oral; initial dose: 3x 0.5mg/d; 2 years
2: Active Comparator short-acting Insulin (Actrapid)	Drug: short-acting Insulin (Actrapid) initial dose: 3x 0.05E/kg/d, injected; 2 years

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).

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662714

Contacts

Contact: Manfred Ballmann, PD Dr.

ballmann.manfred@mh-hannover.de

Locations

Austria
Universitätsklinik für Kinder- und Jugendheilkunde	Completed
Graz, Austria, 8036
Universitätsklinik für Kinder- und Jugendheilkunde	Completed
Wien, Austria, 1090
France
APHP, CRCM pediatrique, Hopital Cochin	Recruiting
Paris, France, 75679
Principal Investigator: Dominique Hubert, Dr.
APHP, CRCM pediatrique, Hopital Necker	Recruiting
Paris, France, 75015
Principal Investigator: G. Lenoir, Dr.
CRCM adultes, Hopital Civil	Recruiting
Strasbourg, France, 67000
Principal Investigator: R. Kessler, Dr.
CRCM adultes, Centre Hospitalier Lyon Sud	Recruiting
Lyon, France, 69495
Principal Investigator: R. Nove-Josserand, Dr.
CRCM adultes	Recruiting
Lille, France, 59037
Principal Investigator: B. Wallaert, Dr.
APHP, CRCM pediatrique, Hopital Robert Debre	Recruiting
Paris, France, 75019
Principal Investigator: Anne Munck, Dr.
Germany
Heliosklinikum Berlin-Buch	Recruiting
Berlin, Germany, 13125
Principal Investigator: Thomas Biedermann, Dr.
Helios Klinikum Emil von Behring	Recruiting
Berlin, Germany, 12200
Principal Investigator: Doris Staab, PD Dr.
Zentralkrankenhaus "Links der Weser"	Recruiting
Bremen, Germany, 28277
Principal Investigator: Martin Claßen, Dr.
Universitätskinderklinik Düsseldorf	Recruiting
Düsseldorf, Germany, 40225
Principal Investigator: Antje Schuster, Prof. Dr.
Klinik für Kinder und Jugendliche Erlangen	Recruiting
Erlangen, Germany, 91054
Principal Investigator: Lutz Nährlich, Dr.
Universitätsklinikum Essen	Recruiting
Essen, Germany, 45147
Principal Investigator: Uwe Mellies, Dr.
Zentrum für Kinderheilkunde Frankfurt	Recruiting
Frankfurt, Germany, 60590
Principal Investigator: Hans-Georg Posselt, Dr.
Klinik und Poliklinik für Kinder- und Jugendmedizin	Recruiting
Greifswald, Germany, 17475
Principal Investigator: Sebastian Schmidt, PD Dr.
Medizinische Hochschule Hannover, Abt. Kinderheilkunde	Recruiting
Hannover, Germany, 30625
Principal Investigator: Manfred Ballmann, PD Dr.
Altona - Klinik	Recruiting
Hamburg, Germany, 22763
Principal Investigator: Hans-Eberhard Heuer, MD
Universitätsklinik für Kinder- und Jugendmedizin	Recruiting
Homburg, Germany, 66421
Principal Investigator: Gerd Dockter, Prof. Dr.
Städtisches Krankenhaus Kiel	Recruiting
Kiel, Germany, 24116
Principal Investigator: Andreas Claaß, PD Dr.
Klinik und Poliklinik für allgemeine Kinderheilkunde	Recruiting
Köln, Germany, 50937
Principal Investigator: Ernst Rietschel, Dr.
Universitätsklinik Mainz	Recruiting
Mainz, Germany, 55101
Principal Investigator: Wolfgang Kamin, Dr.
Clemenshospital	Recruiting
Münster, Germany, 48153
Principal Investigator: Peter Küster, Dr.
Elisabeth Kinderkrankenhaus	Recruiting
Oldenburg, Germany, 26133
Principal Investigator: Holger Köster, Dr.
Kinderhospital Osnabrück	Recruiting
Osnabrück, Germany, 49082
Principal Investigator: Rüdiger Szczepanski, Dr.
Universitätsklinik für Kinder- und Jugendmedizin	Completed
Tübingen, Germany, 72076
Deutsche Klinik für Diagnostik	Recruiting
Wiesbaden, Germany, 65191
Principal Investigator: Klaus-Michael Keller, Prof. Dr.
Julius-Maximilians Universität, Kinderpoliklinik	Recruiting
Würzburg, Germany, 97080
Principal Investigator: H. Hebestreit, Dr.
Ruhrlandklinik Essen	Recruiting
Essen, Germany, 45239
Principal Investigator: Norbert Grammann, MD
Med. Klinik II, Allergologie und Pneumologie	Recruiting
Frankfurt, Germany, 60596
Principal Investigator: Christina Smaczny, Dr.
Klinik Schillerhöhe	Recruiting
Gerlingen, Germany, 70839
Principal Investigator: Justina Kiefer, Dr.
Medizinische Hochschule Hannover, CF-Ambulanz f. Erwachsene	Recruiting
Hannover, Germany, 30625
Principal Investigator: Thomas Köhnlein, Dr.
Prof.-Hess-Kinderklinik/ Zentralkrankenhaus	Completed
Bremen, Germany, 28205
Kinderkrankenhaus Park Schönfeld	Completed
Kassel, Germany, 34121
Klikum der Universität Heidelberg, Kinderklinik	Recruiting
Heidelberg, Germany, 69120
Principal Investigator: Frank-Michael Müller, Prof. Dr.

Sponsors and Collaborators

Mukoviszidose Institut gGmbH

Novo Nordisk

Mucoviscidose-ABCF2

Investigators

Principal Investigator:	Manfred Ballmann, Dr.	Hannover Medical School
Principal Investigator:	Reinhard Holl, Prof.	Zentralinstitut für Biomedizinische Technik Ulm

More Information

Responsible Party:	Mukoviszidose Institut gGmbH ( Jutta Bend )
Study ID Numbers:	F01/01 CF-RD
Study First Received:	April 17, 2008
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00662714
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Metabolic Diseases
Fibrosis
Diabetes Mellitus
Endocrine System Diseases
Insulin
Repaglinide
Digestive System Diseases
Cystic Fibrosis
Respiratory Tract Diseases

Genetic Diseases, Inborn
Lung Diseases
Pancreatic Diseases
Infant, Newborn, Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Cystic fibrosis

Additional relevant MeSH terms:

Hypoglycemic Agents
Pathologic Processes
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009