Positive results for AZ’s type 2 diabetes trial

AstraZeneca has reported positive results from the Phase III DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) of BMS-512148 compared to placebo for the treatment of patients with type 2 diabetes (T2D).

The trial had met its primary safety objective of non-inferiority for major adverse cardiovascular events (MACE).

The trial also achieved one of its two primary composite objectives of a significantly reducing the hospitalisation for heart failure or CV death among the enrolled patients.

In addition, negligible numbers of MACE events were observed with BMS-512148, however, this did not reach statistical significance.

The trial has also validated a well-established safety profile of BMS-512148.

Elisabeth Björk,  AstraZeneca vice-president and Global Medicines Development Cardiovascular, Renal and Metabolism head stated: “BMS-512148 has achieved a statistically significant and clinically important reduction in hospitalisation for heart failure or CV death in a broad range of patients with type 2 diabetes and cardiovascular risk.

“The results from this landmark trial are especially important since heart failure is an early and frequent complication of diabetes and associated with hospitalisations that result in a considerable societal and economic burden.”

The DECLARE-TIMI 58 trial was a randomised, double-blinded, placebo-controlled, multi-centre study that seeks to examine the effect of BMS-512148 in comparison with placebo on CV outcomes in adults with T2D who are at risk of CV events.

It was carried out over a period of five years in more than 17,000 T2D patients who have multiple CV risk factors or established CV disease across 882 sites in 33 countries worldwide.

The trial was conducted in collaboration with academic investigators from the US’ TIMI study group and the Hadassah Hebrew University Medical Center in Jerusalem, Israel.

BMS-512148 is a new oral, once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2).

Source: drug development technology