Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
90 participants
INTERVENTIONAL
2002-10-31
2004-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Insulin Glargine
Insulin glargine at the discretion of the investigator Subcutaneous, once daily injection (at bedtime)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treated concomitantly with insulin once a day and SU over at least 3 months prior to study entry
* Treated with OHA monotherapy over at least 1 year
* HbA1c greater than or equal to 7.5% and less than or equal to 12.0%, at visit 1 (screening visit)
* BMI \< 40 kg/m2
* No history of ketonemia
* Women of childbearing potential using the medically approved contraceptive method
* Ability and willingness to perform blood glucose monitoring using a blood glucose meter as per the requirement of protocol
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
40 Years
80 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Principal Investigators
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Choe Seong Choon
Role: STUDY_DIRECTOR
Sanofi
Other Identifiers
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HOE901_3506
Identifier Type: -
Identifier Source: org_study_id