Status and phase
Conditions
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Study type
Funder types
Identifiers
About
Primary Objective:
To compare the efficacy of a new formulation of insulin glargine (HOE901-U300) to Lantus in terms of change of HbA1c from baseline to endpoint (month 6) in children and adolescents with type 1 diabetes mellitus.
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Secondary Objectives:
To compare HOE901-U300 and Lantus in terms of:
Full description
The study duration per participant was approximately 58 weeks that consisted of a 2 week screening period, a main 6-month comparative efficacy and safety treatment period, a 6-month comparative safety extension period, and a 4-week post treatment follow up period.
Enrollment
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Inclusion and exclusion criteria
Inclusion criteria :
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Primary purpose
Allocation
Interventional model
Masking
463 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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