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Trial record 3 of 4 for:    repaglinide | Cystic Fibrosis

Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT00662714
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : July 10, 2012
Sponsor:
Collaborators:
Novo Nordisk A/S
Mucoviscidose-ABCF2
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Mukoviszidose Institut gGmbH

Tracking Information
First Submitted Date  ICMJE April 17, 2008
First Posted Date  ICMJE April 21, 2008
Last Update Posted Date July 10, 2012
Study Start Date  ICMJE September 2001
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2008)
HbA1c [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis
Official Title  ICMJE Open Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus
Brief 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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cystic Fibrosis
  • Diabetes Mellitus
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Repaglinide; oral
    Intervention: Drug: Repaglinide
  • Active Comparator: 2
    short-acting Insulin (Actrapid)
    Intervention: Drug: short-acting Insulin (Actrapid)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2012)
73
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2008)
74
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   France,   Germany,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00662714
Other Study ID Numbers  ICMJE F01/01 CF-RD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mukoviszidose Institut gGmbH
Study Sponsor  ICMJE Mukoviszidose Institut gGmbH
Collaborators  ICMJE
  • Novo Nordisk A/S
  • Mucoviscidose-ABCF2
  • Assistance Publique - Hôpitaux de Paris
Investigators  ICMJE
Principal Investigator: Manfred Ballmann, Prof. Dr. St. Josef Hospital,Alexandrinenstrasse 5,44791 Bochum, Germany
Principal Investigator: Reinhard Holl, Prof. Zentralinstitut für Biomedizinische Technik Ulm
PRS Account Mukoviszidose Institut gGmbH
Verification Date July 2012

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