RESUMO
Background Type 2 diabetes mellitus (T2DM) patients commonly undergo metformin monotherapy. This study aims to compare the efficacy, safety, and tolerability of combination therapy of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin as add-on therapy in T2DM patients inadequately controlled on metformin. Methodology This was an 18-week, multicenter, randomized, double-blind, active-controlled, parallel-group, phase III clinical study. About 236 participants were randomly assigned to receive either a fixed-dose combination of dapagliflozin 10 mg plus linagliptin 5 mg tablets or a fixed-dose combination of dapagliflozin 10 mg plus vildagliptin SR 100 mg tablets added to metformin monotherapy. The primary outcome was the mean change in hemoglobin A1c (HbA1c) from baseline to the end of week 16. The key secondary endpoints were mean change in postprandial blood glucose (PPBG), fasting blood glucose (FBG), body weight, and the proportion of participants achieving HbA1c less than 7.0%. Results The dapagliflozin/linagliptin combination therapy showed a more significant change in HbA1c from baseline to the end of 16 weeks (mean reduction: -1.59% vs. -1.25%) compared to dapagliflozin/vildagliptin (p < 0.0001). Additionally, compared to the dapagliflozin/vildagliptin group, the dapagliflozin/linagliptin group demonstrated a significant reduction in both PPBG (mean reduction: -59.99 mg/dL vs. -55.34 mg/dL) and FPG (mean reduction: -32.91 mg/dL vs. -26.78 mg/dL). A total of 18 adverse events were reported in 17 (7.20%) participants, all of which were mild and resolved completely. There were no serious adverse events. Conclusions Compared to dapagliflozin and vildagliptin combination therapy, dapagliflozin and linagliptin fixed-dose combination provided clinically significant improvements in glycemic control. Because of its effectiveness, safety, and tolerability, the fixed-dose combination of dapagliflozin and linagliptin was a better option for treating T2DM patients who had previously only received metformin monotherapy.
RESUMO
Extraction of gossypol from cottonseed is essentially required to produce cottonseed free from gossypol for animal feed and or human applications. The focus of the present research was to determine the percentage gossypol extraction after extracting the defatted cottonseed using environment friendly green solvent ethanol-water (95:5 v/v) acidified with 0.5 M oxalic acid. The cottonseed samples were taken according to the fixed solvent to seed ratio and were extracted in batch process using round bottom flasks maintained at required temperatures for different extraction times ranging from 5 to 180 mins. After extraction the samples were filtered and dried and subjected to total gossypol analysis using BIS method. One factor at a time (OFAT) experimental design was employed to optimize the different process parameters like acid type and concentration, solvent to seed ratio, temperature and contact time. The obtained data was studied for analysis of kinetics of extraction using three different kinetic models, calculation of activation energy, evaluating values of kinetic parameters and thermodynamic parameters. The data was also analyzed for evaluation of mass transfer effects viz. liquid film diffusion and internal solid diffusion and calculation of diffusion rate constants for the extraction of gossypol from cottonseed. The present dataset demonstrated the analysis of experimental data for determining the type of kinetics, thermodynamic parameters and mass transfer effects of the solvent extraction for future researchers.
