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Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA
Date:2/19/2013

e treatment of adults with type 2 diabetes.

About GetGoal
The 11 GetGoal clinical trials supporting the lixisenatide NDA filing studied the benefits and risks related to using lixisenatide as monotherapy, in combination with oral anti-diabetic medicines, in combination with basal insulin and versus twice-daily exenatide.

Monotherapy
GetGoal-Mono evaluated the efficacy, safety and tolerability of lixisenatide as monotherapy in comparison to placebo over 12 weeks of treatment.

GetGoal-Mono Japan evaluated the efficacy, safety and tolerability of lixisenatide as monotherapy in patients with type 2 diabetes in Japan over 76 weeks of treatment.

Add-on to oral anti-diabetic medicines
GetGoal-F1 evaluated the efficacy, safety and tolerability of lixisenatide in association with metformin in comparison to placebo over 24 weeks of treatment, followed by an extension period.

GetGoal-S evaluated the efficacy, safety and tolerability of lixisenatide in association with sulfonylurea with or without metformin in comparison to placebo over 24 weeks of treatment, followed by an extension period.

GetGoal-M evaluated the efficacy, safety and tolerability of lixisenatide in association with metformin in comparison to placebo over 24 weeks of treatment, followed by an extension period.

GetGoal-P evaluated the efficacy, safety and tolerability of lixisenatide in association with pioglitazone with or without metformin in comparison to placebo over 24 weeks of treatment, followed by an extension period.

GetGoal-M Asia assessed the effects of lixisenatide as an add-on treatment to metformin with or without sulfonylureas on glycemic control (in terms of HbA1c reduction) in comparison to placebo over 24 weeks of treatment.

Add-on to basal insulin
GetGoal-L Asia evaluated the efficacy, safety and tolerability of lixisenatide in association with basal insulin with or wit
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