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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
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Drug: INSULIN GLARGINE Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2002
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00576862

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Brussels, Belgium
Sponsors and Collaborators
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Study Director: Elke Meyssen Sanofi

Layout table for additonal information Identifier: NCT00576862     History of Changes
Other Study ID Numbers: HOE901_4046
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: January 9, 2008
Last Verified: December 2007

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs