Dapagliflozin and the DECLARE study – the future of treating diabetes mellitus?

Authors: J. Špinar;  R. Lábrová
Authors‘ workplace: Interní kardiologická klinika LF MU a FN Brno
Published in: Kardiol Rev Int Med 2016, 18(2): 119-124


SGLT2 – gliflozins are a possible new treatment of diabetes mellitus type 2. The mechanism of action is excretion of glucose by the kidneys. The first mortality clinical trial with SGLT2 empagliflozin was finished in 2015 and other studies are currently running. Dapagliflozin has a large clinical trial programme, and meta-analysis data from smaller studies have shown a decrease in cardiovascular endpoints. This effect is probably a result of several mechanisms: reduction in blood sugar; blood pressure lowering; reduction in weight; and a diuretic effect. DECLARE is an international clinical trial of dapagliflozin, which is also running in the Czech Republic; the suspected trial closure is in 2018-19. The dapagliflozin clinical trial programme does not only include diabetes mellitus type 2 patients, but also type 1, as well as pediatric patients.

dapagliflozin – DECLARE – mortality


1. Prázný M, Šoupal J. Postavení nových antidiabetik v klinické praxi: SGLT2 vs DPP4 inhibitory. Vnitř Lék 2015; 61: 291– 294.

2. Zinman B, Wan­ner CH, Lachin JM et al. The EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 2015; 373: 2117– 2128. doi: 10.1056/ NEJMoa1504720.

3. Kvapil M. EMPA REG OUTCOME. Důkaz, že populace pa­cientů s diabetem se mění. Remedia 2016; 26: 67– 72.

4. Langkilde AM, Johans­son P, Ptaszynska A et al. Cardiovascular safety of the SGLT2 inhibitor dapagliflozin: meta-analysis with > 6000 patient-years exposure. American Heart As­sociation Scientific Ses­sions 2013. Abstract 11105.

5. Sones­son C, Johans­son PA, Johns­son E et al. Cardiovascular ef­fects of dapagliflozin in patients with type 2 diabetes and dif­ferent risk categories: a meta-analysis. Cardiovasc Diabetol 2016; 15: 37. doi: 10.1186/ s12933-016-0356-y.

6. Fabiánová J. Kardiovaskularni učinky dapagliflozinu u pacientů s diabetes mellitus 2. typu a různou urovni rizika. Farmakoterapie 2016;12(1):1–200.

7. Khaw KT, Wareham N, Bingham S et al. As­sociation of hemoglobin A1c with cardiovascular disease and mortality in adults: the European prospective investigation into cancer in Norfolk. Ann Intern Med 2004; 141: 413– 420.

8. Goto A, Arah OA, Goto M et al. Severe hypoglycae­mia and cardiovascular disease: systematic review and meta-analysis with bias analysis. BMJ 2013; 347: f4533. doi: 10.1136/ bmj.f4533.

9. Fioretto P, Giaccari A, Sesti G. Ef­ficacy and safety of dapagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in diabetes mel­litus. Cardiovasc Diabetol 2015; 14: 142. doi: 10.1186/ s12933-015-0297-x.

10. Weber MA, Mansfield TA, Ales­si F et al. Ef­fects of dapagliflozin on blood pres­sure in hypertensive diabetic patients on renin-angiotensin system blockade. Blood Press 2016; 25: 93– 103. doi: 10.3109/ 08037051.2015.1116258.

11. Fioretto P, Stefans­son BV, Johns­son EKA et al. Dapagliflozin reduces albuminuria over 2 years in diabetic patients with renal impairment. J Am Soc Nephrol 2015; 26: 1A. Abstract TH-OR001.

12. Inzucchi SE, Zinman B, Wan­ner C et al. SGLT-2 inhibitors and cardiovascular risk: proposed pathways and review of ongo­ing outcome trials. Diab Vasc Dis Res 2015; 12: 90– 100. doi: 10.1177/ 1479164114559852.

13. Lambers-Heerspink H, Johns­son E, Gause-Nils­son I et al: Dapaglifl ozin reduces albuminuria on top of renin-angiotensin systém blockade in hypertensive diabetic patients. Diabetes 2015; 64 (Suppl 1): A303. Abstract 1176-P.

14. Clinicaltrials.gov. Multicenter trial to evaluate the ef­fect of dapaglifl ozin on the incidence of cardiovascular events (DECLARE-TIMI58). Available from: https:/ / clinicaltrials.gov/ ct2/ show/ NCT01730534.

15. Ulčianský V, Schroner Z. Fixná kombinácia dapagliflozínu a metformínu v liečbe diabetes mel­litus 2. typu. Súč Klin Pr 2016; 1: 19– 23.

16. Kumar R, Kerins DM, Wather T. Cardiovascular safety of anti-diabetic drugs. Eur Heart J Cardiovasc Pharmacother 2016; 2: 32– 43. doi:  10.1093/ ehjcvp/ pvv035.

Paediatric cardiology Internal medicine Cardiac surgery Cardiology
Forgotten password

Don‘t have an account?  Create new account

Forgotten password

Enter the email address that you registered with. We will send you instructions on how to set a new password.


Don‘t have an account?  Create new account