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Clinical Trial Details

Trial ID: L5557
Source ID: NCT00174642
Associated Drug: Insulin Glargine
Title: Opposing Step-by-step Insulin Reinforcement to Intensified Strategy
Acronym: OSIRIS
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin Glargine|DRUG: Insulin Glulisine|DRUG: Metformin|DRUG: insulin secretagogue
Outcome Measures: Primary: HbA1c, From the beginning to the end of the study|24-hour blood glucose levels, From the beginning to the end of the study|symptomatic hypoglycemia (diurnal and nocturnal), From the beginning to the end of the study|Severe hypoglycemia (diurnal and nocturnal),, From the beginning to the end of the study|Insulin doses, From the beginning to the end of the study | Secondary: Vital signs, From the beginning to the end of the study|Adverse events, From the beginning to the end of the study
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 811
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2004-12
Completion Date:
Results First Posted:
Last Update Posted: 2009-09-15
Locations: Sanofi-Aventis, Brussels, Belgium|Sanofi-Aventis, Paris, France|Sanofi-Aventis, Berlin, Germany|Sanofi-Aventis, Athens, Greece|Sanofi-Aventis, Budapest, Hungary|Sanofi-Aventis, Dublin, Ireland|Sanofi-Aventis, Milan, Italy|Sanofi-Aventis, Seoul, Korea, Republic of|Sanofi-Aventis, Vilnius, Lithuania|Sanofi-Aventis, Mexico, Mexico|Sanofi-Aventis, Gouda, Netherlands|Sanofi-Aventis, Warsaw, Poland|Sanofi-Aventis, Moscow, Russian Federation|Sanofi-Aventis, Barcelona, Spain|Sanofi-Aventis, Stockholm, Sweden|Sanofi-Aventis, Taipei, Taiwan|Sanofi-Aventis, Istanbul, Turkey|Sanofi-Aventis, Guildford, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00174642

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details