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Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis

NCT00662714 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2012-07-10

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Mucoviscidose-ABCF2

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER

  • Mukoviszidose Institut gGmbH

    lead OTHER

Principal Investigators

  • Manfred Ballmann, Prof. Dr. · St. Josef Hospital,Alexandrinenstrasse 5,44791 Bochum, Germany

  • Reinhard Holl, Prof. · Zentralinstitut für Biomedizinische Technik Ulm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Austria
  • France
  • Germany
  • Italy

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00662714 on ClinicalTrials.gov