Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
Primary Objective:
To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to week 26 in patients with type 2 diabetes mellitus.
Secondary Objective:
To compare overall efficacy and safety of LixiLan to insulin glargine over 26 weeks in patients with type 2 diabetes mellitus.
Full description
The maximum study duration per patient will be approximately 41 weeks: an up to 14-week screening period (consisting of an up to 2-week screening phase and a 12-week run-in phase), a 26-week randomized treatment period, and a 3-day post-treatment safety follow-up period.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion criteria :
Exclusion criteria:
Note: Short-term treatment (≤10 days) due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator.
Note:fasting SMPG on the day of randomization can be included if assessed before randomization.
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
513 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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