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Takeda Initiates Outcomes Trial for Alogliptin

Takeda Pharmaceutical Co. Ltd. and Takeda Global Research & Development Center, Inc., received notification that the FDA has agreed to the study design for the cardiovascular (CV) outcomes trial EXAMINE for alogliptin, a selective DPP-IV inhibitor under i

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Takeda Pharmaceutical Co. Ltd. and Takeda Global Research & Development Center, Inc., received notification that the FDA has agreed to the study design for the cardiovascular (CV) outcomes trial EXAMINE for alogliptin, a selective DPP-IV inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise.

The trial will be a multicenter, randomized, double-blind, placebo-controlled study to evaluate cardiovascular outcomes following treatment with alogliptin, in addition to standard of care, in Type 2 Diabetes and acute coronary syndrome, and will include approximately 5,400.

“Takeda received FDA agreement to the design of the CV study and we are pleased to move forward with the study and collecting additional safety data so that the FDA can continue the review of the alogliptin NDA,” said Nancy Joseph-Ridge, M.D., general manager, Pharmaceutical Development Division. “We are committed to conducting this study to satisfy the CV safety requirements, leading to the enhancement of the product profile of alogliptin. While this trial is dependent on the occurrence of CV events, at this point we anticipate that we will be able to submit interim results to the FDA approximately two years after the study begins that will meet the FDA Guidance criteria for drug approval.”

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