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22nd Brazilian Diabetes Society Congress

2019; BioMed Central; Volume: 11; Issue: S1 Linguagem: Inglês

10.1186/s13098-019-0473-3

1758-5996

André Gustavo, Daher Vianna, Claudio S. Lacerda, Luciana Muniz Pechmann, Michelle Garcia Polesel, Ramos Marques, Emerson Cestari Marino, Melchioretto Detsch, Claudia P. Sanches, Filipe Dias de Souza, Patrícia Médici Dualib, Rosiane Mattar, Sérgio Atala Dib, Bianca De, Almeida Pititto, Josilene Lopes De Oliveira, Antônio Luiz, Jonathas Assis De Oliveira, Alice De Souza Paulino, Mayara Medeiros de Freitas Carvalho, Ana Fernandes Viana, Joyce Ferreira Da Costa, Maria Lúcia Pedrosa, Luana Matos de Souza, Natasha Vasconcelos Albuquerque, Milena Sousa, Ana Dias, Rangel Mirna Montenegro, Virgínia Oliveira Fernandes, Carlos Antônio Negrato, Marília De, Brito Gomes, Renan Magalhães, Montenegro Júnior, Jordana Carolina, Marques Godinho Mota, João Felipe Mota, Raquel Machado Schincaglia, Leonardo Soares, Larissa Oliveira Gonçalves, Karine Anusca Martins, Ruffo Freitas‐Júnior,

Healthcare Regulation

Introduction:A reduced number of trials evaluated the effects of SGLT2 inhibitors on glucose pattern by CGM, but neither compared these effects with other class of antidiabetics.This is the first prospective and randomized study to compare the effects of dapagliflozin and an active comparator (gliclazide MR) on GV and glycemic control through the use of CGM parameters in patients with type 2 diabetes mellitus treatment naïve or not controlled on a stable dose of metformin.Objective: This study aims to evaluate whether there is a difference between the effects of dapagliflozin and gliclazide MR (modified release) on glycemic variability (GV) and control, as assessed by continuous glucose monitoring (CGM), in individuals with uncontrolled type 2 diabetes (T2DM).Methods: An open-label, randomized study was conducted in uncontrolled T2DM individuals drug naïve or on steady-dose metformin monotherapy which were treated with 10 mg dapagliflozin once daily or 60 to 120 mg of gliclazide MR once daily.CGM and GV indices calculation were performed at baseline and after 12 weeks.Results: In total, 97 patients (age: 57.9 ± 8.7 years, male sex: 50.5%, baseline glycated hemoglobin (HbA1c): 7.9 ± 0.9) were randomized and 94 completed the 12-week protocol.Per protocol analysis demonstrated that the reduction of GV, as measured by the mean amplitude of glycemic excursions (MAGE), was superior in the dapagliflozin versus gliclazide MR group (-17.8 ± 33.3 vs. -3.3± 42.9 mg/ dL, mean ± SD, p = 0.037).The improvement of GV, as measured by the coefficient of variation (CV) and the standard deviation (SD) was also superior in the dapagliflozin group (p = 0.021 and 0.024, respectively).Moreover, dapagliflozin increased the time in range (TIR, between 70 and 180 mg/dL) by 28.6 ± 24.4% vs. 19.8± 33.1% (p = 0.041).The intention-to-treat (ITT) analysis was also performed and did not alter the significance of the results.Conclusions: Dapagliflozin reduced glycemic variability and increased the TIR more efficiently than gliclazide MR in individuals with T2DM after 12 weeks of treatment as demonstrated by continuous glucose monitoring evaluation.