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Role and importance of high fiber in diabetes management in India.
Saboo, B, Misra, A, Kalra, S, Mohan, V, Aravind, SR, Joshi, S, Chowdhury, S, Sahay, R, Kesavadev, J, John, M, et al
Diabetes & metabolic syndrome. 2022;(5):102480
Abstract
BACKGROUND & AIMS India is facing a triple burden of pre-diabetes, diabetes, and obesity. Unhealthy eating habits and physical inactivity have been linked to the onset and progression of type 2 diabetes mellitus (T2DM). Despite dietary recommendations, individuals consume inadequate amounts or unsuitable type of dietary fiber (DF) which needs correction. An Expert group attempted to review and report on the role and importance of high DF in the management of T2DM and offer practical guidance on high fiber use in daily diet. METHODOLOGY Twelve diabetologists and two expert dietitians from India were chosen to ensure diversity of the members both in professional interest and cultural background. The authors convened virtually for one group meeting and actively participated in a detailed discussion. Multiple reviews of the draft document followed by focused teleconference calls & email helped to reach consensus on final recommendations between Aug 2021 and Dec 2021. RESULTS Evidence has shown that medical nutrition therapy (MNT) is a valuable approach and an essential component of T2DM prevention and management. Studies have shown that fiber rich diabetes nutrition (FDN) has multi-systemic health benefits, including, improvement in glycemic control, reduction in glucose spikes, decrease in hyperinsulinemia, improvement in plasma lipid concentrations and weight management in T2DM patients. CONCLUSION A high fiber diet is vital for people with diabetes and associated conditions. Increasing fiber intake, preferably through food or through dietary supplement, may help. Fiber rich diabetes nutrition (FDN) is recommended in order to prevent and manage T2DM.
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Blood glucose levels should be considered as a new vital sign indicative of prognosis during hospitalization.
Kesavadev, J, Misra, A, Saboo, B, Aravind, SR, Hussain, A, Czupryniak, L, Raz, I
Diabetes & metabolic syndrome. 2021;(1):221-227
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BACKGROUND AND AIMS The measurement of vital signs is an important part of clinical work up. Presently, measurement of blood glucose is a factor for concern mostly when treating individuals with diabetes. Significance of blood glucose measurement in prognosis of non-diabetic and hospitalized patients is not clear. METHODS A systematic search of literature published in the Electronic databases, PubMed and Google Scholar was performed using following keywords; blood glucose, hospital admissions, critical illness, hospitalizations, cardiovascular disease (CVD), morbidity, and mortality. This literature search was largely restricted to non-diabetic individuals. RESULTS Blood glucose level, even when in high normal range, or in slightly high range, is an important determinant of morbidity and mortality, especially in hospitalized patients. Further, even slight elevation of blood glucose may increase mortality in patients with COVID-19. Finally, blood glucose variability and hypoglycemia in critically ill individuals without diabetes causes excess in-hospital complications and mortality. CONCLUSION In view of these data, we emphasize the significance of blood glucose measurement in all patients admitted to the hospital regardless of presence of diabetes. We propose that blood glucose be included as the "fifth vital sign" for any hospitalized patient.
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Remogliflozin Etabonate in the Treatment of Type 2 Diabetes: Design, Development, and Place in Therapy.
Mohan, V, Mithal, A, Joshi, SR, Aravind, SR, Chowdhury, S
Drug design, development and therapy. 2020;:2487-2501
Abstract
Type 2 diabetes mellitus (T2DM) is an emerging epidemic in Asian countries, especially in India. With the advent of the SGLT2 inhibitor class of drugs demonstrating benefits beyond glycemic control, viz. weight loss, blood pressure reduction, and cardiovascular and renal protection, the management of T2DM has taken a quantum leap. Remogliflozin etabonate (RE) is the latest addition to the SGLT2 inhibitor class of drugs that have been recently approved in India for the management of T2DM. RE is a potent and selective inhibitor of SGLT2 with the unique distinction of being administered as a prodrug, existence of active metabolites, and short half-life necessitating twice-daily dosing. The Phase III study of RE demonstrated it to be an efficacious and safe agent and non-inferior to the currently available SGLT2 inhibitors. This paper reviews not only the pharmacokinetics, pharmacodynamics, clinical efficacy, and safety profile of RE but also its molecular and clinical development program. This review has taken into consideration all available published as well as unpublished literature on RE and discusses the individual studies performed during its development for characterization of pharmacological profile.
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Efficacy and Safety of Remogliflozin Etabonate, a New Sodium Glucose Co-Transporter-2 Inhibitor, in Patients with Type 2 Diabetes Mellitus: A 24-Week, Randomized, Double-Blind, Active-Controlled Trial.
Dharmalingam, M, Aravind, SR, Thacker, H, Paramesh, S, Mohan, B, Chawla, M, Asirvatham, A, Goyal, R, Shembalkar, J, Balamurugan, R, et al
Drugs. 2020;(6):587-600
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BACKGROUND Metformin is the first-line treatment for type 2 diabetes mellitus (T2DM), but many patients either cannot tolerate it or cannot achieve glycemic control with metformin alone, so treatment with other glucose-lowering agents in combination with metformin is frequently required. Remogliflozin etabonate, a novel agent, is an orally bioavailable prodrug of remogliflozin, which is a potent and selective sodium-glucose co-transporter-2 inhibitor. OBJECTIVE Our objective was to evaluate the efficacy and safety of remogliflozin etabonate compared with dapagliflozin in subjects with T2DM in whom a stable dose of metformin as monotherapy was providing inadequate glycemic control. METHODS A 24-week randomized, double-blind, double-dummy, active-controlled, three-arm, parallel-group, multicenter, phase III study was conducted in India. Patients aged ≥ 18 and ≤ 65 years diagnosed with T2DM, receiving metformin ≥ 1500 mg/day, and with glycated hemoglobin (HbA1c) levels ≥ 7 to ≤ 10% at screening were randomized into three groups. Every patient received metformin ≥ 1500 mg and either remogliflozin etabonate 100 mg twice daily (BID) (group 1, n = 225) or remogliflozin etabonate 250 mg BID (group 2, n = 241) or dapagliflozin 10 mg once daily (QD) in the morning and placebo QD in the evening (group 3, n = 146). The patients were followed-up at weeks 1 and 4 and at 4-week intervals thereafter until week 24. The endpoints included mean change in HbA1c (primary endpoint, noninferiority margin = 0.35), fasting plasma glucose (FPG), postprandial plasma glucose (PPG), bodyweight, blood pressure, and fasting lipids. Treatment-emergent adverse events (TEAEs), safety laboratory values, electrocardiogram, and vital signs were evaluated. RESULTS Of 612 randomized patients, 167 (group 1), 175 (group 2), and 103 (group 3) patients with comparable baseline characteristics completed the study. Mean change ± standard error (SE) in HbA1c from baseline to week 24 was - 0.72 ± 0.09, - 0.77 ± 0.09, and - 0.58 ± 0.12% in groups 1, 2, and 3, respectively. The difference in mean HbA1c of group 1 versus group 3 (- 0.14%, 90% confidence interval [CI] - 0.38 to 0.10) and group 2 versus group 3 (- 0.19%; 90% CI - 0.42 to 0.05) was noninferior to that in group 3 (p < 0.001). No significant difference was found between group 1 or group 2 and group 3 in change in FPG, PPG, and bodyweight. The overall incidence of TEAEs was comparable across study groups (group 1 = 32.6%, group 2 = 34.4%, group 3 = 29.5%), including adverse events (AEs) of special interest (hypoglycemic events, urinary tract infection, genital fungal infection). Most TEAEs were mild to moderate in intensity, and no severe AEs were reported. CONCLUSION This study demonstrated the noninferiority of remogliflozin etabonate 100 and 250 mg compared with dapagliflozin, from the first analysis of an initial 612 patients. Remogliflozin etabonate therefore may be considered an effective and well-tolerated alternative treatment option for glycemic control in T2DM. TRIAL REGISTRATION CTRI/2017/07/009121.
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The INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) study: Design and methods to address mental healthcare gaps in India.
Kowalski, AJ, Poongothai, S, Chwastiak, L, Hutcheson, M, Tandon, N, Khadgawat, R, Sridhar, GR, Aravind, SR, Sosale, B, Anjana, RM, et al
Contemporary clinical trials. 2017;:113-124
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INTRODUCTION Depression and diabetes are highly prevalent worldwide and often co-exist, worsening outcomes for each condition. Barriers to diagnosis and treatment are exacerbated in low and middle-income countries with limited health infrastructure and access to mental health treatment. The INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) study tests the sustained effectiveness and cost-effectiveness of a multi-component care model for individuals with poorly-controlled diabetes and depression in diabetes clinics in India. MATERIALS AND METHODS Adults with diabetes, depressive symptoms (Patient Health Questionnaire-9 score≥10), and ≥1 poorly-controlled cardiometabolic indicator (either HbA1c≥8.0%, SBP≥140mmHg, and/or LDL≥130mg/dl) were enrolled and randomized to the intervention or usual care. The intervention combined collaborative care, decision-support, and population health management. The primary outcome is the between-arm difference in the proportion of participants achieving combined depression response (≥50% reduction in Symptom Checklist score from baseline) AND one or more of: ≥0.5% reduction in HbA1c, ≥5mmHg reduction in SBP, or ≥10mg/dl reduction in LDL-c at 24months (12-month intervention; 12-month observational follow-up). Other outcomes include control of individual parameters, patient-centered measures (i.e. treatment satisfaction), and cost-effectiveness. RESULTS The study trained seven care coordinators. Participant recruitment is complete - 940 adults were screened, with 483 eligible, and 404 randomized (196 to intervention; 208 to usual care). Randomization was balanced across clinic sites. CONCLUSIONS The INDEPENDENT model aims to increase access to mental health care and improve depression and cardiometabolic disease outcomes among complex patients with diabetes by leveraging the care provided in diabetes clinics in India (clinicaltrials.gov number: NCT02022111).
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Hypoglycemia in patients with type 2 diabetes from India and Malaysia treated with sitagliptin or a sulfonylurea during Ramadan: a randomized, pragmatic study.
Aravind, SR, Ismail, SB, Balamurugan, R, Gupta, JB, Wadhwa, T, Loh, SM, Suryawanshi, S, Davies, MJ, Girman, CJ, Katzeff, HL, et al
Current medical research and opinion. 2012;(8):1289-96
Abstract
OBJECTIVE To compare the incidence of symptomatic hypoglycemia between sitagliptin and sulfonylurea in Muslim patients with type 2 diabetes who fasted during Ramadan. METHODS In a multicenter, pragmatic, randomized study, patients with type 2 diabetes were recruited from clinical centers in India (n = 765) and Malaysia (n = 105). Eligible patients (age ≥ 18 yrs) expressed their intention to daytime fast during Ramadan, were treated with a stable dose of sulfonylurea with or without metformin for ≥3 months prior to screening visit, and had an HbA(1c) ≤ 10%. Patients were randomized in a 1:1 ratio to either switch to sitagliptin 100 mg q.d. or remain on their pre-study sulfonylurea. Daily diary cards were completed to document information on hypoglycemic symptoms and complications. The primary endpoint was the overall incidence of symptomatic hypoglycemia during Ramadan. RESULTS Of the 870 patients randomized, 848 (n = 421 for sitagliptin and 427 for sulfonylurea) returned ≥1 completed diary card and were included in the analysis. The proportion of patients who recorded ≥1 symptomatic hypoglycemic event during Ramadan was lower with sitagliptin (3.8%) compared to sulfonylurea (7.3%). The risk of symptomatic hypoglycemia was significantly lower with sitagliptin (risk ratio [95% CI] = 0.52 [0.29, 0.94]; p = 0.028). By country, the proportions of patients who recorded ≥1 symptomatic hypoglycemic event during Ramadan were 4.1% vs. 7.7% in India and 1.9% vs. 3.8% in Malaysia for sitagliptin and sulfonylurea, respectively. No patient discontinued treatment due to a hypoglycemic event. One patient on sitagliptin and seven on sulfonylurea had an event that required non-medical assistance. No events required medical assistance. Both treatments were generally well tolerated. LIMITATIONS Symptomatic hypoglycemic events did not require a confirmatory blood glucose measurement, which may have overestimated hypoglycemic events. Measures of glycemic control and body weight were not assessed. CONCLUSION Switching antihyperglycemic treatment to sitagliptin from a sulfonylurea reduced the risk of symptomatic hypoglycemia by approximately 50% for Muslim patients with type 2 diabetes who fasted during Ramadan. CLINICAL TRIAL REGISTRATION Clinicaltrials.gov: NCT01340768.