Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis
This study has been completed.
Sponsor:
Mukoviszidose Institut gGmbH
Collaborators:
Novo Nordisk
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
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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
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
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
| 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 May 16, 2013