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Clinical Trial Details

Trial ID: L4488
Source ID: NCT00405418
Associated Drug: Insulin Glargine
Title: Lantus Versus Levemir Treat-To-Target
Acronym: L2T3
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin glargine|DRUG: Insulin Detemir
Outcome Measures: Primary: HbA1c recorded, At baseline, week 12 and week 24|Self-monitored fasting BG in both treatment arms and pre-dinner BG in detemir arm, On the 4 consecutive days before each visit|Self-monitored BG values from 8-point 24-hour profile recorded on 2 consecutive days, Within the week prior to baseline, week 12 and week 24|Episodes of hypoglycemia (symptomatic, total and categorized as day-time/nocturnal, severe or asymptomatic), All across the study|Self-monitored BG values whenever patient experiences symptoms possibly related to hypoglycemia., All across the study | Secondary: Doses of insulin glargine or insulin detemir, Daily|Laboratory fasting plasma glucose, At baseline, week 12 and week 24|Insulinemia and fasting C-peptide level, At baseline|Lipid profile, at baseline and week 24|Patient reported outcomes (quality of life and treatment satisfaction), at baseline, week 4, week 12 and at the last visit|Safety data: occurrence of adverse events and weight, assessed at each visit|Waist and hip circumferences, measured at baseline, week 12 and week 24|Systolic and diastolic blood pressure, measured at study entry, baseline, week 12 and week 24|Physical examination, performed at study entry and at last visit.
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 973
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2006-11
Completion Date:
Results First Posted:
Last Update Posted: 2009-09-15
Locations: Sanofi-Aventis, North Ryde, Australia|Sanofi-Aventis, Sao Paolo, Brazil|Sanofi-Aventis, Laval, Canada|Sanofi-Aventis, Hoersholm, Denmark|Sanofi-Aventis, Helsinki, Finland|Sanofi-Aventis, Berlin, Germany|Sanofi-Aventis, Mumbai, India|Sanofi-Aventis, Dublin, Ireland|Sanofi-Aventis, Seoul, Korea, Republic of|Sanofi-Aventis, Gouda, Netherlands|Sanofi-Aventis, Porto Salvo, Portugal|Sanofi-Aventis, Bucharest, Romania|Sanofi-Aventis, Moscow, Russian Federation|Sanofi-Aventis, Belgrade, Serbia|Sanofi-Aventis, Barcelona, Spain|Sanofi-Aventis, Stockholm, Sweden|Sanofi-Aventis, Meyrin, Switzerland|Sanofi-Aventis, Taipe, Taiwan|Sanofi-Aventis, Istanbul, Turkey|Sanofi-Aventis, Guildford, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00405418