Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Extension to Study HMR1964A/3011 in Belgium

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00576862
First received: December 17, 2007
Last updated: December 28, 2007
Last verified: December 2007

December 17, 2007
December 28, 2007
November 2002
Not Provided
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 ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
Drug: INSULIN GLARGINE
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
April 2004
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00576862
HOE901_4046
Not Provided
Not Provided
Sanofi
Not Provided
Study Director: Elke Meyssen Sanofi
Sanofi
December 2007

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