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Efficacy and safety of dapagliflozin in patients with type 2 diabetes and moderate renal impairment (chronic kidney disease stage 3A): The DERIVE Study
Department of Medicine, University of Padova, Padova, Italy.
Department of Clinical & Experimental Medicine, University of Pisa, Pisa, Italy.ORCID iD: 0000-0002-5388-0270
Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
LMC Diabetes & Endocrinology, Thornhill, Canada.
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2018 (English)In: Diabetes, obesity and metabolism, ISSN 1462-8902, E-ISSN 1463-1326, Vol. 20, no 11, p. 2532-2540Article in journal (Refereed) Published
Abstract [en]

Aims: Dapagliflozin is a selective inhibitor of sodium glucose co-transporter 2 (SGLT2). This study assessed the efficacy and safety of dapagliflozin 10 mg vs placebo in patients with type 2 diabetes (T2D) and moderate renal impairment (estimated glomerular filtration rate [eGFR], 45-59 mL/min/1.73 m(2); chronic kidney disease [CKD] stage 3A). Materials and methods: In this double-blind, parallel group, Phase 3 study (NCT02413398, ) patients with inadequately controlled T2D (HbA1c 7.0%-11.0%) were randomized (1:1) to dapagliflozin 10 mg once daily (N = 160) or matching placebo (N = 161) for 24 weeks. Randomization was stratified by pre-enrolment glucose-lowering therapy. The primary endpoint was change from baseline in HbA1c at Week 24. Results: At Week 24, compared with placebo, dapagliflozin significantly decreased HbA1c (difference [95% CI], -0.34% [-0.53, -0.15]; P < 0.001), body weight (difference [95% CI], -1.25 kg [-1.90, -0.59]; P < 0.001), fasting plasma glucose (difference [95% CI], -0.9 mmol/L [-1.5, -0.4]; P = 0.001) and systolic blood pressure (difference [95% CI], -3.1 mmHg [-6.3, 0.0]; P < 0.05). Decreases from baseline in eGFR were greater with dapagliflozin than placebo at Week 24 (-2.49 mL/min/1.73 m(2) [-4.96, -0.02]), however, eGFR returned to baseline levels at Week 27 (3 weeks post-treatment) (0.61 mL/min/1.73 m(2) [-1.59, 2.81]). No increase in adverse events (AEs; 41.9% vs 47.8%) or serious AEs (5.6% vs 8.7%) were reported with dapagliflozin versus placebo. No AEs of bone fractures, amputations or DKA were reported. Conclusions: The findings of this study (NCT02413398, ) support the positive benefit/risk profile of dapagliflozin for the treatment of patients with T2D and CKD 3A.

Place, publisher, year, edition, pages
Wiley-Blackwell Publishing Inc., 2018. Vol. 20, no 11, p. 2532-2540
National Category
Medical and Health Sciences Endocrinology and Diabetes
Research subject
Bioinformatics; INF502 Biomarkers
Identifiers
URN: urn:nbn:se:his:diva-16379DOI: 10.1111/dom.13413ISI: 000446558100003PubMedID: 29888547Scopus ID: 2-s2.0-85050481073OAI: oai:DiVA.org:his-16379DiVA, id: diva2:1262206
Note

Authors on behalf of the DERIVE Study Investigators

Available from: 2018-11-09 Created: 2018-11-09 Last updated: 2019-04-29Bibliographically approved

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Sartipy, Peter

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