Efficacy and safety of dapagliflozin in patients with type 2 diabetes and moderate renal impairment (chronic kidney disease stage 3A): The DERIVE Study
Diabetes, Obesity and Metabolism Jul 01, 2018
Fioretto P, et al. - In this double-blind, parallel group, phase 3 study, researchers evaluated the effectiveness and safety of dapagliflozin 10 mg vs placebo in subjects with type 2 diabetes (T2D) and moderate renal impairment (estimated glomerular filtration rate 45–59 mL/min/1.73m2; chronic kidney disease [CKD] stage 3A). By pre-enrolment glucose-lowering therapy, randomization was stratified. Change from baseline in HbA1c at Week 24 was the primary endpoint. Dapagliflozin, compared with placebo, significantly lowered HbA1c, body weight, fasting plasma glucose, and systolic blood pressure at week 24, and no increase in adverse events or serious adverse events were seen with dapagliflozin versus placebo. According to the findings, the positive benefit/risk profile of dapagliflozin for the treatment of subjects with T2D and CKD 3A was supported.
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