Impact on Glycemic Variability in Newly Onset T2DM Patients Initiating Dapagliflozin Plus Metformin versus Metformin Alone: A Randomized Open Label Clinical Study. The MAGNNIFY Trial.

Abstract

Abstract ClinicalTrials.gov Identifier: NCT04090580 Registered on November 9th, 2019. https://www.clinicaltrials.gov/ The aim of this study was to compare the effect of dapagliflozin in addition to metformin (DAPA+MET) at maximum tolerated dose in comparison with metformin alone (MET) on glycemic variability (GV) measured by Mean Amplitude of Glycemic Excursions (MAGE), in newly onset Type 2 Diabetes Mellitus (T2DM) subjects.This was an open label randomized clinical trial and we included 88 subjects. The main baseline (W0) characteristics included mean age 52.2±10.4 years, weight 80.6±16.5 kg, Systolic Blood Pressure (SBP) 133.3±19.3mmHg, HbA1c 9.3±1.5%, Estimated Glomerular Filtration Rate (eGFR) 100.5±15.4 ml/min/1.73 m2, MAGE 4.2±1.4 mmol/L. Eighty patients completed follow-up at week 12 (W12) (DAPA+MET, n=41; MET, n=39).For the Intention to treat (ITT n=88) analysis results are presented as Δ, which represents the change between W0 and W12 values.In the analysis between groups DAPA+MET vs. MET. The DAPA+MET group achieved a lower GV ΔMAGE between groups: -0.79 mmol/L, p=0.018, achieved longer periods within ΔTIR (time in range) between groups target glucose levels 70-180 mg/dL: +22.9 % of the day, p=0.003, showed a greater weight reduction Δweight between groups: -2.5 kg, p<0.001 and lower serum insulin levels between groups, Δinsulin: -4.5 µU/mL p=0.029.Patients with new onset T2DM treated with DAPA + MET during a 12-week period presented improvements in GV measured by MAGE, achieved a better TIR% target, lower serum insulin levels, and reduced more weight in comparison with patients treated only with MET as Standard of Care (SOC).Starting a dual treatment of DAPA+ MET in newly onset T2DM patients might prevent or delay the development of complications associated to oxidative stress, originated by GV fluctuations.