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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00576862 |
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Date of registration:
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17/12/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Extension to Study HMR1964A/3011 in Belgium
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Scientific title:
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Multicenter,Open,Uncontrolled,Clinical Extension Trial in Subjects With Type I Diabetes Previously Participating in Study HMR1964A/3011 in Belgium |
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Date of first enrolment:
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November 2002 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00576862 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Elke Meyssen |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus
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Intervention(s)
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Drug: INSULIN GLARGINE
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Primary Outcome(s)
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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]
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Secondary ID(s)
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HOE901_4046
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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