Therapy Areas: Diabetes
Farxiga Achieved a Positive Result in the Phase III DECLARE-TIMI 58 Trial, a Large Cardiovascular Outcomes Trial in 17,000 Patients with Type 2 Diabetes, According to AstraZeneca
25 September 2018 - - Anglo-Swedish biopharmaceutical company AstraZeneca (OTC: AZNCF) has received positive results from the Phase III DECLARE-TIMI 58 cardiovascular outcomes trial for Farxiga (dapagliflozin), the broadest SGLT-2 inhibitor CVOT conducted to date, the company said.

The trial evaluated the CV outcomes of Farxiga vs. placebo over a period of up to five years, across 33 countries and in more than 17,000 adults with type 2 diabetes who have multiple CV risk factors or established CV disease.

In the DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 trial, FARXIGA met its primary safety endpoint of non-inferiority for major adverse cardiovascular events.

Farxiga achieved a statistically-significant reduction in the composite endpoint of hospitalization for heart failure or CV death, one of the two primary efficacy endpoints.

Additionally, fewer MACE events were observed with Farxiga for the other primary efficacy endpoint, however, this did not reach statistical significance. Farxiga is not indicated to reduce the risk of CV events or hHF.

Data from DECLARE-TIMI 58 confirmed the well-established safety profile of Farxiga.

DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI-58 is an AstraZeneca-sponsored, randomised, double-blinded, placebo-controlled, multicenter trial designed to evaluate the effect of Farxiga compared with placebo on CV outcomes in adults with T2D at risk of CV events, including patients with multiple CV risk factors or established CV disease.

DECLARE included more than 17,000 patients across 882 sites in 33 countries and was independently run in collaboration with academic investigators from the TIMI study group (Boston, USA) and the Hadassah Hebrew University Medical Center (Jerusalem, Israel).

DECLARE is part of the extensive DapaCare clinical program for FARXIGA, which will enroll patients in randomized clinical trials, including a wide range of mechanistic studies, and is supported by a multinational real-world evidence study (CVD-REAL).

The DapaCare clinical programme will generate data across a spectrum of people with CV risk factors, established CV disease and varying stages of renal disease, both with and without T2D.

DECLARE is paving the way for three Phase III trials: Dapa-HF, DELIVER and Dapa-CKD.

Cardiovascular, renal and metabolic diseases together form one of AstraZeneca's main therapy areas and platforms for future growth.
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