Takeda Pharmaceutical Co says it is all set to start an additional clinical trial demanded by US regulators on alogliptin, its investigational type 2 diabetes drug.

The Japanese drugmaker noted that the US Food and Drug Administration has agreed to the study design for a cardiovascular outcomes trial, titled EXAMINE for alogliptin, a selective dipeptidyl peptidase IV inhibitor (DPP-4) inhibitor also known as SYR-322. The study will involve 5,400 type 2 diabetes patients at around 1,000 facilities in the USA, Europe and Asia.

Nancy Joseph-Ridge at Takeda’s US subsidiary’s Pharmaceutical Development Division, said the study, which will satisfy the CV safety requirements laid out by the FDA, will lead to “the enhancement of the product profile of alogliptin”. She said the company hopes to submit interim results to the agency approximately two years after the study begins “that will meet the FDA Guidance criteria for drug approval." The EXAMINE study is scheduled for completion in December 2014.

The New Drug Application for alogliptin was submitted in December 2007, a year before the FDA issued fresh guidelines for diabetes drugs but nevertheless the agency issued a complete response letter to Takeda in June, saying it does not believe the amount of existing data “is sufficient to meet certain statistical requirements outlined in that new guidance”.

Having to carry out another trial is a blow to Takeda as alogliptin is seen as vital to its future success as the company prepares for life after diabetes blockbuster Actos (pioglitazone), which loses patent protection in the USA in 2011. Also the delay means that alogliptin will continue to lose ground on Merck & Co's DPP-4 inhibitor Januvia (sitagliptin), which is well-established on the market.