DECLARE-TIMI 58 (Dapagliflozin Effect on CardiovascuLAR Events) was a multi-national, randomized, double-blind, placebo-controlled Phase IIIB trial jointly led by the TIMI Study Group and Hadassah Medical Center, and sponsored by AstraZeneca and Bristol-Myers Squibb. DECLARE – TIMI 58 was a superiority trial and designed to test the hypothesis that in patients with type 2 diabetes mellitus long-term treatment with dapagliflozin, an oral sodium glucose cotransporter 2 (SGLT2) inhibitor, will reduce one or both of the co-primary endpoints: (1) the incidence cardiovascular death, myocardial infarction, or ischemic stroke or (2) the incidence of cardiovascular death or hospitalization for heart failure. The trial also sought to definitively exclude unacceptable cardiovascular risk from dapagliflozin in these patients. It randomized approximately 17,150 patients with type 2 diabetes mellitus and either known cardiovascular disease (secondary prevention cohort) or at least two risk factors for cardiovascular disease (primary prevention cohort). DECLARE-TIMI 58 was an event-driven trial.


MAIN RESULTS:Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes
N Engl J Med. 2019 Jan 24;380(4):347-357.


Main Results (Wiviott, AHA 2018)
Effect of dapa on HF in T2DM (Kato, LBCT, ACC 2019)
Dapa and Outcomes in Patients with PAD (Bonaca, ACC 2019)
Dapagliflozin and CV Outcomes in Patients with T2DM and Prior MI in DECLARE (Furtado ACC 2019)
Dapa and CV Outcomes – Patients with T2DM According to Baseline Kidney Function and Albuminuria Status (Zelniker, ESC 2019)
HF Risk Stratification and Efficacy of SGLT2 Inhibitors in Patients with T2DM (Berg ESC 2019)
DECLARE DAPA and AF (Zelniker AHA 2019)
DECLARE Dapa Biomarker (Zelniker AHA 2019)
DECLARE Efficacy in T2DM Poster (O’Donoghue AHA 2019)
A Targeted Proteomic Approach to Identify Circulating Biomarkers of Heart Failure Risk in Patients with T2DM in DECLARE-TIMI 58 (Berg, AHA 2020)
Development of A Novel Biomarker-Based Risk Score for Heart Failure in Patients with Diabetes (Berg, AHA 2020)
Cardiovascular Risk Stratification and Efficacy of Dapagliflozin on Cardiovascular Outcomes in Patients with T2DM in the DECLARE-TIMI 58 Trial (Oyama, AHA 2020)
Relationship between cardiac biomarkers and major adverse cardiovascular events in DECLARE-TIMI 58 (Zelniker, AHA 2020)


The design and rationale for the Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 Trial. Am Heart J. 2018 Jun;200:83-89.

DECLARE-TIMI 58: Participants’ baseline characteristics. Diabetes Obes Metab. 2018 May;20(5):1102-1110.

Effect of Dapagliflozin on Heart Failure and Mortality in Type 2 Diabetes Mellitus. Circulation. 2019 May 28;139(22):2528-2536.

Dapagliflozin and Cardiovascular Outcomes in Patients with Type 2 Diabetes and Prior Myocardial Infarction: A Sub-analysis From DECLARE TIMI-58 Trial. Circulation. 2019 May 28;139(22):2516-2527.

Effects of dapagliflozin on development and progression of kidney disease in patients with type 2 diabetes: an analysis from the DECLARE-TIMI 58 randomised trial. Lancet Diabetes Endocrinol. 2019 Aug;7(8):606-617.

Heart Failure Risk Stratification and Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes Mellitus. Circulation. 2019 Nov 5;140(19):1569-1577.

Efficacy and Safety of Dapagliflozin in the Elderly: Analysis From the DECLARE-TIMI 58 Study. Diabetes Care. 2020 Feb;43(2):468-475.

Effect of Dapagliflozin on Atrial Fibrillation in Patients with Type 2 Diabetes Mellitus: Insights from the DECLARE-TIMI 58 Trial. Circulation. 2020 Apr 14;141(15):1227-1234.

Cardiovascular and renal benefits of dapagliflozin in patients with short and long-standing type 2 diabetes: analyses from the DECLARE-TIMI 58 trial. Diabetes Obes Metab. 2020 Jul;22(7):1122-1131.

Safety of dapagliflozin in a broad population of patients with type 2 diabetes – analyses from the DECLARE – TIMI 58 study. Diabetes Obes Metab. 2020 Aug;22(8):1357-1368.

Dapagliflozin and Cardiac, Kidney and Limb Outcomes in Patients With and Without Peripheral Artery Disease in DECLARE-TIMI 58. Circulation. 2020 Aug 25;142(8):734-747.

Cardiorenal Outcomes with Dapagliflozin by Baseline Glucose Lowering Agents -Post-hoc Analyses from DECLARE-TIMI 58. Diabetes Obes Metab. 2021 Jan;23(1):29-38.

Relationship between baseline cardiac biomarkers and cardiovascular death or hospitalization for heart failure with and without SGLT2 inhibitor therapy in DECLARE-TIMI 58. Eur J Heart Fail. 2020 Dec 2.

Sex, Permanent Drug Discontinuation, and Study Retention in Clinical Trials: Insights From the TIMI trials. Circulation. 2021 Feb 16;143(7):685-695. doi: 10.1161/CIRCULATIONAHA.120.052339. 

The efficacy and safety of dapagliflozin in women and men with type 2 diabetes mellitus. Diabetologia. 2021 Feb 20. doi: 10.1007/s00125-021-05399-2..

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