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Clinical Trial Details

Trial ID: L3757
Source ID: NCT00174668
Associated Drug: Insulin Glulisine
Title: Insulin Glulisine in Diabetes Mellitus, Type 2
Acronym: GINGER
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin Glulisine|DRUG: Insulin Therapy|DRUG: Insulin Glargine
Outcome Measures: Primary: HbA1c, From baseline to study endpoint|Self monitored BG (SMBG) values, During the whole treatment phase|Body weight/body mass index (BMI), From baseline to study endpoint and all other visits|Fasting blood lipid profile, From baseline to study endpoint and all other visits|Urine albumin, From baseline to study endpoint and all other visits|Total daily insulin dose, From baseline to study endpoint | Secondary: Adverse events, Throughout the study,|Standard laboratory tests, From baseline to study endpoint and all other visits|Vital signs, From baseline to study endpoint and all other visits|Physical examination, From baseline to study endpoint and all other visits
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 311
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2004-11
Completion Date:
Results First Posted:
Last Update Posted: 2009-09-15
Locations: Sanofi-Aventis, North Ryde, Australia|Sanofi-Aventis, Brussels, Belgium|Sanofi-Aventis, Prague, Czech Republic|Sanofi-Aventis, Paris, France|Sanofi-Aventis, Berlin, Germany|Sanofi-Aventis, Milan, Italy|Sanofi-Aventis, Gouda, Netherlands|Sanofi-Aventis, Warsaw, Poland|Sanofi-Aventis, Porto Salvo, Portugal|Sanofi-aventis, Bucharest, Romania|Sanofi-Aventis, Bratislava, Slovakia|Sanofi-Aventis, Barcelona, Spain|Sanofi-Aventis, Stockholm, Sweden|Sanofi-Aventis, Meyrin, Switzerland|Sanofi-Aventis, Guildford, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00174668