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Extension to Study HMR1964A/3011 in Belgium

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: December 17, 2007
Last updated: December 28, 2007
Last verified: December 2007
The purpose of this trial is to allow patients to continue on HOE 901 until launch and to gather additional long-term safety data.

Condition Intervention Phase
Diabetes Mellitus Drug: INSULIN GLARGINE Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter,Open,Uncontrolled,Clinical Extension Trial in Subjects With Type I Diabetes Previously Participating in Study HMR1964A/3011 in Belgium

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Evolution of efficacy parameters between first study visit (V1) and last study visit (V5) [ Time Frame: Mean time interval: 10 months ]

Enrollment: 32
Study Start Date: November 2002
Study Completion Date: April 2004
Arms Assigned Interventions
Experimental: 1 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00576862

Brussels, Belgium
Sponsors and Collaborators
Study Director: Elke Meyssen Sanofi
  More Information Identifier: NCT00576862     History of Changes
Other Study ID Numbers: HOE901_4046
Study First Received: December 17, 2007
Last Updated: December 28, 2007

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on June 23, 2017