DECLARE-TIMI 58: Participants' baseline characteristics

Itamar Raz, Ofri Mosenzon, Marc P. Bonaca, Avivit Cahn, Eri T. Kato, Michael G. Silverman, Deepak L. Bhatt, Lawrence A. Leiter, Darren K McGuire, John P.H. Wilding, Ingrid A.M. Gause-Nilsson, Anna M. Langkilde, Peter A. Johansson, Marc S. Sabatine, Stephen D. Wiviott

Research output: Contribution to journalArticle

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Aim: To describe the baseline characteristics of participants randomized in the Dapagliflozin Effect on CardiovascuLAR Events (DECLARE-TIMI 58) trial, the pivotal study conducted to assess cardiovascular (CV) outcomes with dapagliflozin. Methods: The DECLARE-TIMI 58 trial will analyse 17160 patients with type 2 diabetes randomized to treatment with dapagliflozin (10mg/d) or matching placebo. We analysed their baseline characteristics. Results: The participants' mean±SD age was 63.8±6.8years, 62.6% were male, and their mean±SD diabetes duration was 11.8±7.8years, glycated haemoglobin 8.3%±1.2% (67 mmol/mol ± 9.7 mmol/mol) and body mass index 32.1±6.0kg/m2. Randomization included 6971 (40.6%) patients with atherosclerotic CV disease (CVD), and 10189 (59.4%) patients with multiple risk factors (MRF) for CVD (defined as men age ≥55years or women ≥60years, with at least one of dyslipidaemia, hypertension or smoking). Patients with CVD compared with patients with MRF were younger (62.5±8.1 vs 64.7±5.6years), more frequently male (72.1% vs 56.1%), less often used metformin (74.6% vs 81.2%), more often used insulin (44.2% vs 36.4%), and more frequently used statins, aspirin, clopidogrel and β-blockers (82.2%, 71.1%, 24.7% and 66.6% vs 63.7%, 39.1%, 1.5% and 32.3%, respectively). Conclusion: The DECLARE-TIMI 58 trial is expected to provide conclusive data on the effect of treatment with dapagliflozin in addition to standard of care, on CV outcomes in a broad patient population with type 2 diabetes and CVD or MRF for CVD.

Original languageEnglish (US)
JournalDiabetes, Obesity and Metabolism
StateAccepted/In press - Jan 1 2017



  • Cardiovascular outcomes
  • CVOTs
  • Dapagliflozin
  • SGLT2 inhibitors
  • Type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Raz, I., Mosenzon, O., Bonaca, M. P., Cahn, A., Kato, E. T., Silverman, M. G., Bhatt, D. L., Leiter, L. A., McGuire, D. K., Wilding, J. P. H., Gause-Nilsson, I. A. M., Langkilde, A. M., Johansson, P. A., Sabatine, M. S., & Wiviott, S. D. (Accepted/In press). DECLARE-TIMI 58: Participants' baseline characteristics. Diabetes, Obesity and Metabolism.