Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events

Phase 3 Completed 17190 enrolled AstraZeneca Bristol-Myers Squibb · collab Hadassah Medical Organization · collab The TIMI Study Group · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.

Timeline

Start: 2013-04-25
Primary completion: 2018-09-11
Completion: 2018-09-11

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry analysis (superiority test); Dapa 10 mg vs Placebo; p = 0.172; Hazard Ratio (HR) 0.93 (95% CI 0.84 to 1.03); Regression, Cox reads as mixed primary results NCT01730534 ↗

registry analysis (superiority test); Dapa 10 mg vs Placebo; p = 0.005; Hazard Ratio (HR) 0.83 (95% CI 0.73 to 0.95); Regression, Cox reads as mixed primary results NCT01730534 ↗

release “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 (MACE).” reads as mixed primary results astrazeneca.com ↗

release “Farxiga achieved a statistically-significant reduction in the composite endpoint of hospitalisation for heart failure (hHF) or CV death, one of the two primary efficacy endpoints.” reads as mixed primary results astrazeneca.com ↗

release “Additionally, fewer MACE events were observed with Farxiga for the other primary efficacy endpoint, however, this did not reach statistical significance.” reads as mixed primary results astrazeneca.com ↗

release “DECLARE-TIMI 58 showed that Farxiga significantly reduced the risk of the primary composite endpoint of hHF or CV death versus placebo by 17%” reads as mixed primary results astrazeneca.com ↗

release “There were fewer major adverse CV events observed with Forxiga for the other primary efficacy endpoint, however this did not reach statistical significance.” reads as mixed primary results astrazeneca.com ↗

release “DECLARE-TIMI 58 demonstrated that Forxiga achieved a statistically significant reduction in the composite endpoint of hospitalisation for heart failure (hHF) or cardiovascular (CV) death” reads as met primary endpoint astrazeneca.com ↗

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dapagliflozin	Small molecule	10 mg	Oral