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news.Boehringer Ingelheim and Eli Lilly and Company have announced that the four completed Phase III clinical trials of empagliflozin met the primary efficacy endpoint.
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The primary efficacy endpoint of the studies was defined as a significant change in HbA1c from baseline compared to placebo with empagliflozin 10mg and 25mg once daily doses.
Empagliflozin investigational sodium glucose co-transporter-2 inhibitor is being studied for treatment of patients with type 2 diabetes.
Boehringer Ingelheim medicine corporate senior vice president Prof. Klaus Dugi said, "Many patients with type 2 diabetes are not meeting their blood sugar level goals, and alternative treatment options are needed for them."
The studies include Study 1245.20, Study 1245.23, Study 1245.19 and Study 1245.36.
Similar adverse event profile was established in the studies for placebo, empagliflozin 10mg and 25g and consistent safety information was reported.
Lilly Diabetes president Enrique Conterno said, "Diabetes is growing at a tremendous rate across the world. Patients and their physicians need more treatment options in order to help improve their blood sugar levels and reach their treatment goals."
In 2013, Boehringer and Lilly will file for regulatory review of empagliflozin in the US, Europe and Japan.