Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis

This study has been completed.
Sponsor:
Collaborators:
Novo Nordisk A/S
Mucoviscidose-ABCF2
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Mukoviszidose Institut gGmbH
ClinicalTrials.gov Identifier:
NCT00662714
First received: April 17, 2008
Last updated: July 6, 2012
Last verified: July 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Mukoviszidose Institut gGmbH:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: September 2001
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Repaglinide; oral
Drug: Repaglinide
oral; initial dose: 3x 0.5mg/d; 2 years
Active Comparator: 2
short-acting Insulin (Actrapid)
Drug: short-acting Insulin (Actrapid)
initial dose: 3x 0.05E/kg/d, injected; 2 years
Other Name: Actrapid

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Austria
Universitätsklinik für Kinder- und Jugendheilkunde
Graz, Austria, 8036
Universitätsklinik für Kinder- und Jugendheilkunde
Wien, Austria, 1090
France
CRCM adultes
Lille, France, 59037
CRCM adultes, Centre Hospitalier Lyon Sud
Lyon, France, 69495
APHP, CRCM pediatrique, Hopital Necker
Paris, France, 75015
APHP, CRCM pediatrique, Hopital Robert Debre
Paris, France, 75019
APHP, CRCM pediatrique, Hopital Cochin
Paris, France, 75679
CRCM adultes, Hopital Civil
Strasbourg, France, 67000
Germany
Heliosklinikum Berlin-Buch
Berlin, Germany, 13125
Helios Klinikum Emil von Behring
Berlin, Germany, 12200
Zentralkrankenhaus "Links der Weser"
Bremen, Germany, 28277
Prof.-Hess-Kinderklinik/ Zentralkrankenhaus
Bremen, Germany, 28205
Universitätskinderklinik Düsseldorf
Düsseldorf, Germany, 40225
Klinik für Kinder und Jugendliche Erlangen
Erlangen, Germany, 91054
Universitätsklinikum Essen
Essen, Germany, 45147
Ruhrlandklinik Essen
Essen, Germany, 45239
Zentrum für Kinderheilkunde Frankfurt
Frankfurt, Germany, 60590
Med. Klinik II, Allergologie und Pneumologie
Frankfurt, Germany, 60596
Klinik Schillerhöhe
Gerlingen, Germany, 70839
Klinik und Poliklinik für Kinder- und Jugendmedizin
Greifswald, Germany, 17475
Altona - Klinik
Hamburg, Germany, 22763
Medizinische Hochschule Hannover, Abt. Kinderheilkunde
Hannover, Germany, 30625
Medizinische Hochschule Hannover, CF-Ambulanz f. Erwachsene
Hannover, Germany, 30625
Klikum der Universität Heidelberg, Kinderklinik
Heidelberg, Germany, 69120
Universitätsklinik für Kinder- und Jugendmedizin
Homburg, Germany, 66421
Kinderkrankenhaus Park Schönfeld
Kassel, Germany, 34121
Städtisches Krankenhaus Kiel
Kiel, Germany, 24116
Klinik und Poliklinik für allgemeine Kinderheilkunde
Köln, Germany, 50937
Universitätsklinik Mainz
Mainz, Germany, 55101
Clemenshospital
Münster, Germany, 48153
Elisabeth Kinderkrankenhaus
Oldenburg, Germany, 26133
Kinderhospital Osnabrück
Osnabrück, Germany, 49082
Kinderklinik Dritter Orden, Sozialpädiatrisches Zentrum
Passau, Germany, 94032
Universitätsklinik für Kinder- und Jugendmedizin
Tübingen, Germany, 72076
Julius-Maximilians Universität, Kinderpoliklinik
Würzburg, Germany, 97080
Italy
Centro Fibrosi Cistica
Verona, Italy, 37100
Sponsors and Collaborators
Mukoviszidose Institut gGmbH
Novo Nordisk A/S
Mucoviscidose-ABCF2
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Manfred Ballmann, Prof. Dr. St. Josef Hospital,Alexandrinenstrasse 5,44791 Bochum, Germany
Principal Investigator: Reinhard Holl, Prof. Zentralinstitut für Biomedizinische Technik Ulm
  More Information

No publications provided by Mukoviszidose Institut gGmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mukoviszidose Institut gGmbH
ClinicalTrials.gov Identifier: NCT00662714     History of Changes
Other Study ID Numbers: F01/01 CF-RD
Study First Received: April 17, 2008
Last Updated: July 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Cystic Fibrosis
Diabetes Mellitus
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Repaglinide
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014