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

April 17, 2008
July 6, 2012
September 2001
December 2011   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00662714 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis
Open Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cystic Fibrosis
  • Diabetes Mellitus
  • Drug: Repaglinide
    oral; initial dose: 3x 0.5mg/d; 2 years
  • Drug: short-acting Insulin (Actrapid)
    initial dose: 3x 0.05E/kg/d, injected; 2 years
    Other Name: Actrapid
  • Experimental: 1
    Repaglinide; oral
    Intervention: Drug: Repaglinide
  • Active Comparator: 2
    short-acting Insulin (Actrapid)
    Intervention: Drug: short-acting Insulin (Actrapid)
Schmid K, Fink K, Holl RW, Hebestreit H, Ballmann M. Predictors for future cystic fibrosis-related diabetes by oral glucose tolerance test. J Cyst Fibros. 2014 Jan;13(1):80-5. doi: 10.1016/j.jcf.2013.06.001. Epub 2013 Jun 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
10 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Germany,   Italy
 
NCT00662714
F01/01 CF-RD
No
Mukoviszidose Institut gGmbH
Mukoviszidose Institut gGmbH
  • Novo Nordisk A/S
  • Mucoviscidose-ABCF2
  • Assistance Publique - Hôpitaux de Paris
Principal Investigator: Manfred Ballmann, Prof. Dr. St. Josef Hospital,Alexandrinenstrasse 5,44791 Bochum, Germany
Principal Investigator: Reinhard Holl, Prof. Zentralinstitut für Biomedizinische Technik Ulm
Mukoviszidose Institut gGmbH
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP