Extension to Study HMR1964A/3011 in Belgium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00576862
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : January 9, 2008
Information provided by:

December 17, 2007
December 19, 2007
January 9, 2008
November 2002
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Evolution of efficacy parameters between first study visit (V1) and last study visit (V5) [ Time Frame: Mean time interval: 10 months ]
Same as current
Complete list of historical versions of study NCT00576862 on Archive Site
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Extension to Study HMR1964A/3011 in Belgium
Multicenter,Open,Uncontrolled,Clinical Extension Trial in Subjects With Type I Diabetes Previously Participating in Study HMR1964A/3011 in Belgium
The purpose of this trial is to allow patients to continue on HOE 901 until launch and to gather additional long-term safety data.
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Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus
The subjects will continue the treatment with HOE 901 in the same way as they have done in the previous study. Based on the investigator's assessment and the approved SPC in Belgium/Luxembourg, the dosage can be adjusted individually. HOE 901 is to be injected once daily. HOE 901 must not be mixed with any other insulin, including regular human insulin or fast-acting insulin analogues.
Experimental: 1
Intervention: Drug: INSULIN GLARGINE
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2004
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Inclusion Criteria:

  • Subjects treated with HOE901 and who, in the judgement of the investigator, have benefited from the use of HOE 901 in a previous clinical study with HOE 901.
  • Subjects treated with HOE 901 in a previous clinical study with HOE 901 for whom a change of basal insulin would destabilise glucose metabolism.
  • Subjects who are likely to comply with the investigator's instructions.

Exclusion Criteria:

  • Evidence of an uncooperative attitude.
  • Subject not on adequate contraception, or who is pregnant, or breast feeding.
  • Subject unable to understand informed consent.
  • Patient receiving or likely to receive HOE901 treatment outside of SPC or PI recommendations.
  • Subject becomes pregnant or is planning to become pregnant.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Study Director: Elke Meyssen Sanofi
December 2007

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