Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
Primary Objective:
To test the hypothesis that basal insulin based treatment (G+) is noninferior to twice-daily premixed insulin (PM-2) in term of hemoglobin A1c (glycosylated hemoglobin, HbA1c) reduction from baseline to end of study. The test for superiority can be done if noninferiority is achieved.
Secondary Objectives:
Full description
The duration of study is approximately 21 months. Each patient will be followed for approximately 27 weeks from screening visit to end-of-study
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion criteria :
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Primary purpose
Allocation
Interventional model
Masking
384 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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