A Multicenter, Double-Blind, Randomized, Active Controlled Study to Compare the Effect of 52 Weeks Treatment with LAF237 50 mg bid to Gliclazide up to 320 mg Daily as Add-On Therapy in Patients with T...

Update Il y a 5 ans
Reference: EUCTR2004-000542-20

A Multicenter, Double-Blind, Randomized, Active Controlled Study to Compare the Effect of 52 Weeks Treatment with LAF237 50 mg bid to Gliclazide up to 320 mg Daily as Add-On Therapy in Patients with Type 2 Diabetes Inadequately Controlled with Metformin Monotherapy

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Extract

Primary objective: To confirm the efficacy of add-on therapy with LAF237 in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy by testing the hypothesis that the HbA1c reduction with LAF237 is not inferior to that with gliclazide after 52 weeks of treatment.


Inclusion criteria

  • Type 2 Diabetes