Researchers have found no evidence in current literature as to whether sodium-glucose contransporter-2 (SGLT-2) inhibitors are able to prevent or delay the development of type 2 diabetes mellitus (T2DM) and its complications in patients at risk for developing T2DM.
For their analysis the researchers – from Denmark and Germany – searched electronic records from the Cochrane Central Register of Controlled Trials, Ovid MEDLINE, PubMed, EMBASE, ClinicalTrials.gov, and the World Health Organization International Clinical. Study participants had to meet the dysglycemia diagnosis criteria set down by ADA 1997; ADA 2010; NDDG 1979; WHO 1999, to be included.
Their initial search identified 874 records, however after removing duplicates and trials with people diagnosed with ‘metabolic syndrome’ (as according to the authors, this population is not representative of people with just intermediate hyperglycemia), the researchers could not identify any trial which examined SGLT-2 treatment in T2DM at-risk populations.
One reference of potential interest was only published as two abstracts (Sarich 2010; Sarich 2010a), while three other retrieved references referred trials that were ongoing (EudraCT 2015-001552-30; NCT02338193; NCT01248364).
Two of the three ongoing trials are evaluating the effects of dapagliflozin in a cohort of at-risk T2DM patients. Follow-up times are 24 and 26 weeks, respectively. Both trials will mainly report on surrogate outcome measures with some data on adverse effects and health-related quality of life.
The authors conclude by cautioning on the vigilance of future studies and interventions, stating that “interfering with the life of non-diseased persons has to demonstrate very firm beneficial effects on patient-important outcomes, because even rare but severe adverse effects when translated to population wide settings, could result in deleterious consequences impacting huge numbers of people.”
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