scholarly journals A real-world clinical experience on the effectiveness of remogliflozin etabonate in management of Indian patients with type II diabetes mellitus

Author(s):  
Soumya Sengupta ◽  
Sunita Sengupta ◽  
Sagar Katare

Background: The aim of the study was to evaluate effectiveness and safety of remogliflozin etabonate in a real-world outpatient setting in type 2 diabetes mellitus (T2DM) patients in India.Methods: A retrospective, observational, single-center study wherein medical records of adult patients (≥18 years old) with T2DM managed with remogliflozin 100 mg for at least three months at the diabetes care center in Jharkhand were retrieved. The effectiveness was assessed in terms of change from baseline in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPG), total body weight, blood pressure (BP, systolic and diastolic), kidney function tests, and lipid parameters after three months of treatment. Safety was assessed by adverse events (AEs) and serious AEs.Results: Half of the patients received ≥3 concomitant antidiabetic drugs, common being sulphonylureas (92%), and metformin (91%). Remogliflozin treatment resulted in a significant mean reduction from baseline in HbA1c [-1.99 (0.12%); p<0.001], FPG [-52.3 (4.31) mg/dl; p<0.001] and PPG [-103.6 (7.10) mg/dl; p<0.001). Bodyweight reduction was not statistically significant [-0.1 (10.12) kg]. A significant reduction was observed in the systolic BP [-15.9 (2.21) mmHg; p<0.001] and diastolic BP [-3.3 (0.95) mmHg; p=0.001]. Commonly reported AE was heartburn (51.4%) and urinary tract infections (34.2%). No serious AEs were reported. The mean estimated glomerular filtration rate showed a statistically significant reduction of -1.55 (0.61) ml/min. The lipid parameter findings were non-significant.Conclusions: The real-world experience of remogliflozin administered concomitantly with other antidiabetic drugs was effective and well-tolerated in Indian patients with T2DM. 

2019 ◽  
Vol 9 (9) ◽  
pp. 576 ◽  
Author(s):  
Joy Amadi ◽  
Chinagorom Asinobi

AbstractBackground: Diet-related chronic disease especially diabetes mellitus, cardiovascular disease (CVDs), obesity, hypertension and cancers is a major public health problem in Nigeria. The use of locally made foods has been advocated for in the management of diabetes mellitus in recent times.Methods: The recipe for the test food was developed and standardized. Proximate and dietary fibre analysis was carried out on the test food (okra, African spinach and lettuce sauces) and reference food (white bread). Thirty-six non-diabetic undergraduate students of Imo State University, Nigeria were selected after diabetes screening using oral glucose tolerance test (OGTT), glycated hemoglobin, anthropometric indices, blood pressure and other exclusion criteria. Subjects consumed a serving portion of vegetable sauce containing 25g of digestible carbohydrate. Postprandial plasma glucose was measured at 0, 15, 30, 45, 60, 90 and 120 minutes. The glycemic index and load was calculated per serving. Results were expressed in means, standard deviation and percentages. ANOVA was used in comparing the means while turkey test was used in separating the means using Statistical product for service solution (SPSS) version 22.0. The decision criteria was set at p<0.05.Results: Moisture content ranged from 64.10±0.57% (okra sauce) to 64.62±0.66% (lettuce sauce) did not differ significantly (p<0.05). Fat, fibre, and ash content higher in lettuce sauce 3.40± 0.24%, 1.69±0.1%2, and 4.40±0.24% respectively, carbohydrate was higher in African spinach (15.07±0.77%) while dietary fibre (3.26±0.01%), protein (15.15±0.09%) and energy (136.62±2.24 kcal) was higher in okra sauce. Sauces were not significantly different. White bread shows that  moisture content was 17.62, fat 1.53%, protein 14.86%, ash 6.90%, carbohydrate 58.88%, energy 308.66kcal and dietary fibre 0.33.The anthropometric indices show that BMI of the subjects ranged from 23.12kg/m2 in African spinach sauce subjectsto 23.53kg/m2 (okra sauce subjects). WHR was highest in lettuce sauce subjects (0.84). All the subjects that participated were all females. HbA1C was higher in okra sauce (5.23%) group subjects. Systolic blood pressure was 119.08mmHg (African Spinach sauce subjects) while diastolic blood pressure was highest in lettuce sauce subjects (85.68mmHg). Pulse rate (85.17) was highest in okra sauce subject. The IUAC for the white bread was significantly (p<0.05) higher in all the subjects compared to the vegetable sauces with a high glycemic index and load of 93.25 and 54.91 respectively. African spinach sauce had a lower postprandial plasma glucose peak of 88.00mg/dl at 60 minutes compared to okra and lettuce sauces. All the vegetable sauces had a low glycemic index of 17.02 (okra sauce), 14.05 (African spinach) and 36.76 (lettuce) and low glycemic load was 0.75, 0.38 and 3.80 for okra, African spinach and lettuce sauces respectively.Conclusion: All the vegetable sauces studied should be used while planning meal for the diabetic patients.Keywords: vegetable sauces, glycemic response, healthy adults 


BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e033659 ◽  
Author(s):  
Nick Freemantle ◽  
Riccardo C Bonadonna ◽  
Pierre Gourdy ◽  
Didac Mauricio ◽  
Dirk Mueller-Wieland ◽  
...  

IntroductionType 2 diabetes mellitus (T2DM) is a common and heterogeneous disease. Using advanced analytic approaches to explore real-world data may identify different disease characteristics, responses to treatment and progression patterns. Insulin glargine 300 units/mL (Gla-300) is a second-generation basal insulin analogue with preserved glucose-lowering efficacy but reduced risk of hypoglycaemia. The purpose of the REALI pooled analysis described in this paper is to advance the understanding of the effectiveness and real-world safety of Gla-300 based on a large European patient database of postmarketing interventional and observational studies.Methods and analysisIn the current round of pooling, REALI will include data from up to 10 000 subjects with diabetes mellitus (mostly T2DM) from 20 European countries. Outcomes of interest include change from baseline to week 24 in haemoglobin A1c, fasting plasma glucose, self-measured plasma glucose, body weight, insulin dose, incidence and rate of any-time-of-the-day and nocturnal hypoglycaemia. The data pool is being investigated using two complementary methodologies: a conventional descriptive, univariate and multivariable prognostic analysis; and a data-mining approach using subgroup discovery to identify phenotypic clusters of patients who are highly associated with the outcome of interest. By mid-2019, deidentified data of 7584 patients were included in the REALI database, with a further expected increase in patient number in 2020 as a result of pooling additional studies.Ethics and disseminationThe proposed study does not involve collection of primary data. Moreover, all individual study protocols were approved by independent local ethics committees, and all study participants provided written informed consent. Furthermore, patient data is deidentified before inclusion in the REALI database. Hence, there is no requirement for ethical approval. Results will be disseminated via peer-reviewed publications and presentations at international congresses as data are analysed.


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