|Year : 2022 | Volume
| Issue : 2 | Page : 58-68
Clinical Utility of Glimepiride and Metformin Fixed-Dose Combination in Obese/Overweight Patients with Type 2 Diabetes Mellitus in Indian Settings
Binayak Sinha1, Saket Kant2, Sabyasachi Bandyopadhyay3, Sagarika Mukherjee4, Dasarathi Sarkar5, Kiran P Singh6, Tirthankar Chaudhury3, Surender Kumar7, Rahimuddin Ahmed8, Mahesh Abhyankar9, Ashish Prasad9, Mayuri Talathi9
1 Department of Endocrinology, AMRI Hospital-Salt Lake; Department of Endocrinology, GD Hospital and Diabetes Institute, Kolkata, West Bengal, India
2 Ananda Medicare, Gurudwara Sant Samagam, Rohini, Delhi, India
3 Department of Endocrinology, Apollo Gleneagles Hospital, Kolkata, West Bengal, India
4 Dr. Sagarika Mukherjee's Clinic, Kolkata, West Bengal, India
5 Department of Endocrinology, S.S.K.M Hospital, Kolkata, West Bengal, India
6 Department of Endocrinology, Fortis Hospital, Mohali, Punjab, India
7 Department of Endocrinology, Shri Ganga Ram Hospital, Delhi, India
8 Ahmed Diabetes Care Centre and Life Style Clinic, Kacharigoan, Assam, India
9 Scientific Services, USV Private Limited, Mumbai, Maharashtra, India
|Date of Submission||02-Apr-2022|
|Date of Decision||29-May-2022|
|Date of Acceptance||31-May-2022|
|Date of Web Publication||16-Jul-2022|
Scientific Services, USV Private Limited, Mumbai, Maharashtra
Source of Support: None, Conflict of Interest: None
Background: In India, glimepiride has become a promising option for add-on therapy with metformin in patients with type-2 diabetes mellitus (T2DM) owing to its efficacy, safety, and cost-effectiveness. This study aimed to analyze the clinical utility of multiple strengths of glimepiride and metformin fixed-dose combination (FDC) in obese/overweight patients with T2DM. Methods: This case-based questionnaire survey was conducted between June 2020 and June 2021 and included health-care professionals across India to assess the usage pattern of glimepiride and metformin FDC. Results: Overall, data from 1345 patients taking multiple strengths of glimepiride and metformin FDC were analyzed, of which 64.7% were men. A total of 57.6% of patients were overweight, 29.4% were obese Class I, 9.6% were obese Class II, and 3.4% belonged to obese Class III. Sedentary lifestyle (60.3%), smoking (36.7%), and emotional stress (33.3%) were the most common risk factors. Among the available strengths, glimepiride 2 mg and metformin 500/850/1000 mg FDC was most widely used in 50.5% and 47.4% of patients from overweight and obese groups, respectively. A total of 90.3% and 89.1% of patients, respectively, from the overweight and obese groups did not observe weight gain. The majority of the patients from overweight and obese groups observed blood pressure within optimum levels (68.5% and 71.4%, respectively). The mean glycated hemoglobin, fasting plasma glucose, and postprandial plasma glucose levels were significantly reduced with posttreatment of glimepiride and metformin FDC with a mean change of 1.4%, 44.3 mg/dL, and 73.5 mg/dL, respectively (P < 0.01). The physician global evaluation of efficacy (90.3%) and tolerability (91.1%) showed the majority of the patients on a good to excellent scale. Conclusion: The real-world evidence in the Indian clinical setting indicates that the glimepiride and metformin FDC was found to be effective in achieving glycemic control and it is observed to be safer in terms of weight gain and hypoglycemia.
Keywords: Fasting plasma glucose, glycemic control, glycated hemoglobin, hypoglycemia, postprandial plasma glucose, weight gain
|How to cite this article:|
Sinha B, Kant S, Bandyopadhyay S, Mukherjee S, Sarkar D, Singh KP, Chaudhury T, Kumar S, Ahmed R, Abhyankar M, Prasad A, Talathi M. Clinical Utility of Glimepiride and Metformin Fixed-Dose Combination in Obese/Overweight Patients with Type 2 Diabetes Mellitus in Indian Settings. Chron Diabetes Res Pract 2022;1:58-68
|How to cite this URL:|
Sinha B, Kant S, Bandyopadhyay S, Mukherjee S, Sarkar D, Singh KP, Chaudhury T, Kumar S, Ahmed R, Abhyankar M, Prasad A, Talathi M. Clinical Utility of Glimepiride and Metformin Fixed-Dose Combination in Obese/Overweight Patients with Type 2 Diabetes Mellitus in Indian Settings. Chron Diabetes Res Pract [serial online] 2022 [cited 2022 Aug 10];1:58-68. Available from: https://cdrpj.org//text.asp?2022/1/2/58/351258
| Introduction|| |
The worldwide prevalence of obesity is increasing at an alarming rate and has gained a significant attention as one of the most prevalent risk factors of type 2 diabetes mellitus (T2DM). India is no exception to this rising trend of prevalence of overweight and obesity. The prevalence of overweight and obesity is expected to double by the end of 2040. In India, the majority of the individuals with T2DM are either overweight or obese. Further, overweight or obese individuals with T2DM are at a significant risk of developing cardiovascular diseases (CVDs) and which eventually results in increased morbidity and mortality. Therefore, it is of great significance for health-care providers to consider the impact of any selected drug therapy on the weight of individuals with T2DM who are overweight or obese.
Several international and national guidelines recommend the use of a fixed-dose combination (FDC) of two or more antidiabetic agents for better and sustained glycemic control with a low risk of adverse events including hypoglycemia and weight gain.,,, The literature demonstrates that glimepiride is associated with several benefits including optimal insulin secretion, enhanced beta-cell function, weight-neutral effects, absence of CVD risk, and reduced hypoglycemia. Considering these benefits, glimepiride has become a promising option for add-on therapy with metformin in patients with T2DM.
In India, glimepiride and metformin FDC is usually preferred for the management of T2DM. This FDC is advantageous in terms of its easy availability in multiple strengths thereby providing easy titration choices for physicians in the routine clinical practice. A recent Indian study depicted the benefits of glimepiride and metformin FDC therapy for the management of T2DM in obese individuals. Furthermore, the use of this FDC is associated with a low risk of hypoglycemia. However, evidence from clinical trials and real-world studies supporting its use, particularly in overweight or obese patients with T2DM in Indian clinical practice is limited. Therefore, the present observational study was conducted to understand the usage pattern of glimepiride and metformin FDC therapy in overweight or obese patients with T2DM in Indian settings.
| Methods|| |
A multicenter case-based questionnaire survey was conducted at 125 sites in Indian health-care centers (between June 2020 and June 2021) having medical records of overweight or obese patients with T2DM, who had received glimepiride and metformin FDC therapy. A standard questionnaire pertaining to overweight or obese with T2DM management using glimepiride and metformin FDCs was prepared, discussed, and validated by the experts.
Data related to baseline characteristics, duration of disease, dosage pattern, comorbidities, concomitant medications, up-titration, hypoglycemia, weight gain, and adverse events were collected from medical records authenticated by physicians during routine care.
Patients of either sex, age above 18 years, who were overweight or obese and had received any strength of glimepiride and metformin FDCs for the treatment of T2DM and approval of the treating physician to provide information regarding the participant's treatment were enrolled in this study. Patients with incomplete data or any condition that according to the investigator makes the patient unsuitable for inclusion in the study were excluded. [Figure 1] displays the process flow chart.
Patients were categorized into overweight and obese groups using the World Health Organisation's definition: Overweight: body mass index (BMI) of 25–29.9 kg/m2, Class I obese: BMI of 30–34.9 kg/m2, Class II obese: BMI of 35–39.9 kg/m2, Class III (morbid) obese: BMI of ≥40 kg/m2.,
The objective of this study was to evaluate the demographic characteristics of overweight or obese patients receiving different strengths of glimepiride and metformin FDCs, duration of T2DM, risk factors, comorbidities, complications of diabetes, duration of diabetes complications, lipid parameters, fasting plasma glucose (FPG), and postprandial plasma glucose (PPG), glycated hemoglobin (HbA1c) levels, concomitant medications, duration of therapy, the dosage of up-titration and down-titration, reasons for up- and down-titration, change in glycemic parameters, weight changes, and hypoglycemia during the therapy. The present study also examined the total cholesterol, triglycerides, high-density lipoprotein (HDL), and low-level lipoprotein-cholesterol across all BMI groups. Furthermore, the study also focused on other management strategies and physicians' global evaluation of efficacy and tolerability of glimepiride and metformin FDCs.
Risk factors for T2DM included excess alcohol and salt intake. Excess alcohol intake was defined as consuming ≥15 drinks per week. Excess salt intake was defined consumption of >5 g sodium per day. Health-Care Professionals (HCPs) were asked to categorize patients on basis of their economic status in one of the following group: Rich, Upper Middle, Lower Middle and Poor. All other qualitative and semi quantitative variables were recorded and analysed based on responses provided by HCPs.
Diabetic microvascular complications included nephropathy, retinopathy, and neuropathy. Diabetic nephropathy is a syndrome characterized by the presence of pathological quantities of albumin-to-creatinine ratio (≥30 mg/g), diabetic glomerular lesions, and loss of glomerular filtration rate (<60 mL/min/1.73 m2) in diabetes. Diabetic retinopathy is a condition that may occur in patients with diabetes which can cause progressive damage to the retina. Neuropathy is dysfunction of one or more peripheral nerves that typically results in (i) numbness in lower limbs or feet, (ii) loss of or decreased ankle jerk reflex, and (iii) tingling sensation. Macrovascular complications including CVD consisted of coronary artery disease (CAD), ischemic stroke, and peripheral artery disease.
Statistical testing was done using Statistical Package for the Social Sciences (SPSS) version 22.0. (Armonk NY: IBM United States). Baseline features were summarized with descriptive statistics, including median and for continuous variables, and frequency and percentages for categorical variables. The data from all the participating physicians were pooled for analysis and evaluable patient data were analyzed.
| Results|| |
A total of 125 health-care professionals participated in online surveys. Overall, data from 1345 patients taking multiple strengths of glimepiride and metformin FDC were analyzed. The average weight of the patients was 79.0 kg. In this survey, 57.6% of patients belonged to the overweight group (BMI: 25–29.9 kg/m2), 29.4% to obese Class I (BMI: 30–34.9 kg/m2), 9.6% to obese Class II (BMI: 35–39.9 kg/m2), and 3.4% belonged to obese Class III (BMI ≥40 kg/m2). The average levels of systolic and diastolic blood pressure were 134.6 and 85.9 mmHg, respectively. The median duration of T2DM was 6.0 years (range: 0.1–32.0 years). Sedentary lifestyle (60.3%), smoking (36.7%), and emotional stress (33.3%) were predominantly observed in patients with T2DM. Similarly, excess alcohol consumption was common among these patients (20.5%). The majority of the patients reported a family history of T2DM (76.2%) and HTN (33.3%). Neuropathy (28.4%) and retinopathy (25.0%) were the most common microvascular complications among patients with T2DM. The median duration of comorbid conditions including dyslipidemia, HTN, and nonalcoholic fatty liver disease was 4.0 years, 5.0 years, and 1.8 years, respectively [Table 1]. HTN (62.2%) and dyslipidemia (47.1%) were the most common comorbidities followed by hyperthyroidism (7.8%), sleep apnea (7.4%), arthritis (7.2%), nonalcoholic fatty liver disease (6.8%), hyperuricemia (4.7%), heart failure (1.9%), polycystic ovary syndrome (1.3%), and chronic obstructive pulmonary disease (0.4%) [Figure 2].
|Figure 2: Comorbidities with T2DM. T2DM = type-2 diabetes mellitus, COPD = Chronic obstructive pulmonary disease, HTN = Hypertension, NAFLD = Nonalcoholic fatty liver disease, PCOS = Polycystic ovary syndrome|
Click here to view
Overweight versus obese
The mean age was significantly higher in overweight patients compared to those with obese patients (55.5 vs. 53.8 years; P = 0.006). Male preponderance was observed in both overweight (69.5% vs. 30.5% P < 0.001) obese groups (58.1% vs. 41.1%, P < 0.001). The median duration of T2DM was longer in overweight patients than those in obese patients (6.4 vs. 5.4 years, P < 0.001). Among risk factors, excess salt intake was higher in obese patients with T2DM compared to overweight patients with T2DM (28.8% vs. 15.2%). The majority of the obese patients had a positive family history of T2DM (76.4%) and HTN (41.0%) [Table 1].
Higher BMI was associated with higher levels of triglycerides and lower levels of HDL cholesterol [Table 2].
|Table 2: Lipid profiles across body mass index range in patients with type-2 diabetes mellitus|
Click here to view
Treatment patterns and posttreatment observations
A total of 79.7% of overweight and 82.1% of obese patients received glimepiride and metformin FDC as a first-line therapy. Among available five strengths, of glimepiride 2 mg and metformin 500/850/1000 mg FDC was most widely prescribed in 50.5% and 47.4% of patients from overweight and obese groups, respectively, followed by strength of glimepiride 1 mg and metformin 500/850/1000 mg FDC (33.9% and 31.1%), glimepiride 0.5 mg and metformin 500/1000 mg FDC (8.7% and 13.4%), glimepiride 3 mg and metformin 850/1000 mg FDC (6.2% and 7.2%). A total of 5.0% and 3.9% of patients, respectively, from the overweight and obese groups were on insulin therapy (P = 0.307). During the course of treatment, up-titration of glimepiride and metformin FDC was performed in 38.6% and 37.9% of patients from overweight and obese groups, respectively, while down titration was performed in 5.2% and 7.2% of patients from overweight and obese groups, respectively. Hypoglycemia was reported in 6.5% and 6.0% of patients from the overweight and obese groups, respectively. A total of 90.3% and 89.1% of patients, respectively, from the overweight and obese groups did not observe weight gain. The majority of the patients from overweight and obese groups observed blood pressure within optimum levels (68.5% and 71.4%, respectively) [Table 3].
Other oral antidiabetic drugs
Other oral antidiabetic drugs and concomitant medications are depicted in [Table 4]. A total of 51.2% (n = 689) of patients received glimepiride and metformin FDC along with other antidiabetic medication. The majority of the patients (n = 454) received concomitant medications along with combination therapy. A total of 324 (71.4%) patients received antihypertensive therapy along with glimepiride and metformin FDC.
Effect of glimepiride and metformin fixed-dose combination on glycemic parameters
A significant reduction in HbA1c, FPG, and PPG levels was observed postglimepiride and metformin FDC treatment with a mean change of 1.4%, 44.3 mg/dL, and 73.5 mg/dL, respectively (P < 0.001). Among overall patients, posttreatment of glimepiride and metformin FDC therapy significantly reduced the levels of HbA1c (8.3 vs. 7.0%; P < 0.001), FPG (173.0 vs. 128.6 mg/dL; P < 0.001), and PPG (240.2 vs. 166.7 mg/dL, P < 0.001) as compared to pretreatment levels [Figure 3].
|Figure 3: Change in glycemic parameters. FPG = Fasting plasma glucose, HbA1c = Hemoglobin A1c, PPG = Postprandial plasma glucose|
Click here to view
Reduction in HbA1c, FPG, and PPG levels was observed postglimepiride and metformin FDC treatment in both patients who had insulin and those without insulin dose. Posttreatment of glimepiride and metformin FDC therapy reduced the levels of HbA1c (mean change: 1.9% and 1.4%, respectively), FPG (mean change: 44.4 mg/dL and 44.3 mg/dL, respectively), and PPG (mean change 95.6 mg/dL and 72.5 mg/dL, respectively) in both patient who had insulin and those without insulin dose [Figure 4]a, [Figure 4]b, [Figure 4]c.
|Figure 4: (a) HbA1c levels, (b) FPG levels, and (c) PPG levels with respect to insulin and noninsulin groups. HbA1c = Glycated hemoglobin, FPG = Fasting plasma glucose, PPG = Postprandial plasma glucose|
Click here to view
Reduction in glycated hemoglobin with respect to age groups
Higher reduction in HbA1c levels (>35%) was observed in the age group of ≥40–50 years (n = while lower reduction was observed in the age group of ≥50–60 years (n = 51) [Figure 5].
Reduction in glycated hemoglobin with respect to duration of type-2 diabetes mellitus
Higher reduction in HbA1c levels (>35%) was observed in patients with lower duration of T2DM (≥2–<4 years [n = 3]) while lower reduction was observed in patients with lower as well as higher duration of T2DM (≥4–<6 years [n = 33], ≥6–<8 years [n = 33], and ≥8–<10 [n = 32]) [Figure 6].
Other management strategies
Among other management strategies, dietary modification (54.3%) was the most common modality followed by 30 min of walk (51.7%), recording of glucose measurements (41.0%), weight loss programs (36.4%), recording of blood pressure measurements (33.1%), and low sodium diet (24.7%) [Figure 7].
Efficacy and tolerability
The overall global assessment for efficacy and tolerability was good to excellent scale for a majority of the patients (90.3% and 91.1%, respectively) [Figure 8]a and [Figure 8]b. During survey, each of the participating HCP was asked to respond for efficacy and tolerability (from Fair to Excellent) for each of the patients.
|Figure 8: (a) Physicians' global evaluation of efficacy, (b) physicians' global evaluation of tolerability|
Click here to view
| Discussion|| |
Obese individuals with T2DM pose a significant risk of premature CVDs with increased morbidity and mortality. Therefore, early diagnosis and subsequent management are fundamental steps in alleviating morbidities and mortality. Current evidence highlights the alarming rise in the prevalence of obesity in patients with T2DM. Literature supports the safety and effectiveness of glimepiride and metformin FDC in lowering levels of HbA1c including other beneficial effects such as minimal weight gain. The present study determined the usage pattern of glimepiride and metformin FDC in the overweight or obese patients in the Indian cohort diagnosed with T2DM.
The key observations of this study were (i) male preponderance; (ii) sedentary lifestyle, smoking, and emotional stress were predominantly observed in patients; (iii) most commonly used daily regimen was glimepiride 2 mg and metformin 500/850/1000 mg FDC in overweight or obese patients with T2DM; (iv) hypoglycemia were reported in 6.5% and 6.0% of patients and weight gain was observed in 9.7% and 10.9% of patients from the overweight and obese groups, respectively; (v) majority of patients from overweight and obese groups observed blood pressure within optimum levels; (vi) mean HbA1c, FPG, and PPG levels significantly decreased posttreatment with glimepiride and metformin FDC; and (vii) the overall global assessment for efficacy and tolerability was good to excellent scale for a majority of the patients suggesting an overall good response.
Different studies have documented that the prevalence of obesity in patients with T2DM is considerably higher in adult women than in men., A study by Daousi et al. reported the prevalence of women patients over men among the obese patients with T2DM (67.3% vs. 32.7%). Another evidence-based Turkish nationwide survey of glycemic and other Metabolic parameters of patients with Diabetes mellitus (TEMD study) Obesity Study reported the prevalence of obesity nearly in 90% of Turkish patients with type 2 diabetes. Further authors also reported that women with T2DM were having 2.5 times greater risk of developing obesity than men and have a 16.5% prevalence of severe obesity. The recent national health survey from India revealed that the adult-aged women (35–49 years) age group had a greater prevalence of obesity-associated T2DM than young adult individuals (18–34 years). In contrast to previous studies in the literature, the present study showed a significantly higher male preponderance in the overall overweight and obese patients than women. The higher incidence of T2DM among obese men may be attributable to the high prevalence of sedentary lifestyle, smoking, and excessive alcohol consumption witnessed in the population.
A recently published cross-sectional study demonstrated that alcohol consumption, smoking, obesity, and family history of DM were significantly associated with the prevalence of diabetes. Similarly, sedentary lifestyle, smoking, emotional stress, obesity, and family history were the most common risk factors observed in this study. These findings are in concordance with Agrawal et al. and Keller et al., wherein alcohol consumption, sedentary lifestyle, smoking, overnutrition, and physical inactivity were the factors shown to be strongly associated with T2DM., Furthermore, data from the Asian study indicated that concurrent use of alcohol and tobacco has a synergistic effect on diabetes risk.
Glimepiride in combination with metformin is not only safe and effective in providing better glycemic control with good durability but also an easily accessible approach for the management of T2DM with complications. In this study, 50.5% and 47.4% of patients, respectively, from overweight and obese groups were on glimepiride 2.0 and metformin 500/850/1000 mg FDC therapy. These observations concord with SUs consensus statement of South Asia Federation of Endocrine Societies, wherein they recommended the use of glimepiride as preferred agents for the management of overweight or obese patients with T2DM. Similarly, Unnikrishnan et al. reported various strengths of glimepiride and metformin FDC therapy for the management of overweight or obese patients with T2DM in India. They reported, a total of 667 (46.6%) patients were on glimepiride 2 mg and metformin 500/850/1000 mg FDC which is similar to the present study. Hypoglycemia is a major limiting factor in tight glycemic management in patients with T2DM. Among the overall patients, a significant reduction in HbA1c, FPG, and PPG levels was observed postglimepiride and metformin FDC treatment (P < 0.05) with minimal hypoglycemia and weight gain effects. The risk of severe hypoglycemia was observed only in 0.6% of patients. These results are in accordance with the previous consensus report in which they recommended glimepiride over conventional sulphonylureas in overweight or obese T2DM patients due to less risk of hypoglycemia. Similarly, a multicenter study from Korea suggested that glimepiride and metformin FDC provides greater reductions in HbA1c (6.6% vs. 7.0%) and the adjusted mean difference between groups was 0.4% with statistical significance (P < 0.001).
These observations corroborate the previous study findings indicating the effectiveness of high-dose metformin in achieving good glycemic control with weight neutral effect. Glimepiride and metformin FDC offered advantages including improved glycemic control with minimal side effects such as weight gain and hypoglycemia. Previous real-world evidence from India have demonstrated the superior efficacy of glimepiride and metformin FDC therapy for the treatment of early as well as long-standing diabetes. A previous real-world study conducted among 1211 patients with T2DM showed that glimepiride and metformin FDC was effective in achieving the targeted glycemic control with weight neutral effect. Various evidence suggests that the treatment with all the strengths of the glimepiride and metformin FDCs are widely prescribed in diabetes with or without comorbidities for optimal glycemic control with a minimal risk of hypoglycemia, CVD risk, and weight gain events.,,, In agreement with previous observations glimepiride and metformin FDC was associated with lower propensity to cause weight gain. In the present study, <10% of patients from both overweight and obese groups observed weight gain.
Glimepiride and metformin FDC showed favorable safety and tolerability in terms of cardiovascular profile as compared to older generation sulfonylureas. A large retrospective cohort study showed the clinical evidence of a trend toward an increased overall mortality risk with glyburide or glipizide versus glimepiride in those with CVD and preferred glimepiride in those with underlying CAD. The Cardiovascular Outcome Study of Linagliptin vs. Glimepiride in Type 2 Diabetes (CAROLINA) reaffirmed the clinical safety of SUs as add-on therapy to metformin in patients with early T2DM and elevated cardiovascular risk. The randomized, multicenter Thiazolidinediones Or Sulfonylureas Cardiovascular Accidents Intervention Trial (TOSCA. IT) was performed to study the incidence of cardiovascular (CV) events following the addition of pioglitazone versus glimepiride to metformin in patients with T2DM. The study showed that the incidence of CV events was similar with sulfonylureas and pioglitazone as add-on therapy to metformin, thereby highlighting the CV safety of glimepiride. Similarly, in the present study majority of patients were from overweight and obese group observed blood pressure within optimum levels.
The authors acknowledge a few limitations of this study. First, the study is a retrospective analysis that has inherited limitations including selection bias or recall bias. Hence, there is a need for well-designed prospective studies to validate these results. In dual combination drug, there may be challenges in evaluating the adverse events which may have been caused due to any one of the drugs. However, this is an inherent challenge in FDC therapy. In addition, there may be challenges in increasing/decreasing the dose or in final stage titration with individual ingredients however, an availability of different FDC formulations may help with this issue.
| Conclusion|| |
Glimepiride and metformin FDC therapy is widely used in clinical practice due to good glycemic control, minimal risk of hypoglycemia, and weight gain. The current multicenter case-based questionnaire study showed that glimepiride and metformin FDC (glimepiride 2 mg and metformin 500/850/1000 mg FDC) was found to be effective in the treatment of T2DM patients across BMI with or without comorbidity. The majority of the patients did not observe weight gain and hypoglycemia. The average blood pressure was within optimum level across all BMI range. Overall results indicated good efficacy and tolerability in terms of achieving glycemic control and it is observed to be safer in terms of weight gain, hypoglycemia, and cardiovascular risk.
We acknowledge all the contributors who contributed to the data collection. We also acknowledge Mr. A Thamburaj and Shashikala Borhade from USV Pvt. Ltd. for their assistance in the conduct of the project. The medical writing support was provided by Ruchika Thale from Sqarona Medical Communications LLP (Pune).
As this was a questionnaire-based survey from HCPs and did not capture any identifiable information of patients, no EC approval was sought.
Financial support and sponsorship
The study was funded by USV Private Limited, Mumbai, India.
Conflicts of interest
Dr. Ashish Prasad and Dr. Mayuri Talathi are employees of USV Pvt Ltd. Dr. Mahesh Abhyankar was an employee of USV Pvt Ltd during the conduct of the study. All other authors have no conflict of interest to declare.
| References|| |
Luhar S, Timæus IM, Jones R, Cunningham S, Patel SA, Kinra S, et al
. Forecasting the prevalence of overweight and obesity in India to 2040. PLoS One 2020;15:e0229438.
Cheng V, Kashyap SR. Weight considerations in pharmacotherapy for type 2 diabetes. J Obes 2011;2011:984245.
American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: Standards of medical care in diabetes-2021. Diabetes Care 2021;44 Suppl 1:S111-24.
Chawla R, Madhu SV, Makkar BM, Ghosh S, Saboo B, Kalra S, et al
. RSSDI-ESI clinical practice recommendations for the management of type 2 diabetes mellitus 2020. Indian J Endocrinol Metab 2020;24:1-122.
Basit A, Riaz M, Fawwad A. Glimepiride: Evidence-based facts, trends, and observations (GIFTS). [corrected]. Vasc Health Risk Manag 2012;8:463-72.
Singh SK. Commentary on “consensus recommendations on sulfonylurea and sulfonylurea combinations in the management of type 2 diabetes mellitus: International task force”. Indian J Endocrinol Metab 2018;22:158-9.
Unnikrishnan AG, Pandit K, George J, Venkatraman S, Mv A. Clinical utilization pattern of multiple strengths of glimepiride and metformin fixed dose combinations in Indian type 2 diabetes patients. J Assoc Physicians India 2020;68:57-61.
Bhupathiraju SN, Hu FB. Epidemiology of obesity and diabetes and their cardiovascular complications. Circ Res 2016;118:1723-35.
Kautzky-Willer A, Harreiter J, Pacini G. Sex and gender differences in risk, pathophysiology and complications of type 2 diabetes mellitus. Endocr Rev 2016;37:278-316.
Daousi C, Casson IF, Gill GV, MacFarlane IA, Wilding JP, Pinkney JH. Prevalence of obesity in type 2 diabetes in secondary care: Association with cardiovascular risk factors. Postgrad Med J 2006;82:280-4.
Sonmez A, Yumuk V, Haymana C, Demirci I, Barcin C, Kıyıcı S, et al
. Impact of obesity on the metabolic control of type 2 diabetes: results of the Turkish nationwide survey of glycemic and other metabolic parameters of patients with diabetes mellitus (TEMD obesity study). Obes Facts 2019;12:167-78.
Vennu V, Abdulrahman TA, Bindawas SM. The prevalence of overweight, obesity, hypertension, and diabetes in India: Analysis of the 2015-2016 national family health survey. Int J Environ Res Public Health 2019;16:E3987.
Asiimwe D, Mauti GO, Kiconco R. Prevalence and risk factors associated with type 2 diabetes in elderly patients aged 45-80 years at Kanungu district. J Diabetes Res 2020;1:1-5.
Agrawal P, Mercer A, Hassanali J, Carmack C, Doss D, Murillo R. Gender differences in the association between alcohol use and sedentary behavior among adults. Am J Health Promot 2018;32:1576-81.
Keller S, Maddock JE, Hannöver W, Thyrian JR, Basler HD. Multiple health risk behaviors in German first year university students. Prev Med 2008;46:189-95.
Gupta PC, Maulik PK, Pednekar MS, Saxena S. Concurrent alcohol and tobacco use among a middle-aged and elderly population in Mumbai. Natl Med J India 2005;18:88-91.
Sahay RK, Mittal V, Gopal GR, Kota S, Goyal G, Abhyankar M, et al
. Glimepiride and metformin combinations in diabetes comorbidities and complications: Real-world evidence. Cureus 2020;12:e10700.
Kalra S, Aamir AH, Raza A, Das AK, Azad Khan AK, Shrestha D, et al
. Place of sulfonylureas in the management of type 2 diabetes mellitus in South Asia: A consensus statement. Indian J Endocrinol Metab 2015;19:577-96.
Kim HS, Kim DM, Cha BS, Park TS, Kim KA, Kim DL, et al
. Efficacy of glimepiride/metformin fixed-dose combination vs. metformin uptitration in type 2 diabetic patients inadequately controlled on low-dose metformin monotherapy: A randomized, open label, parallel group, multicenter study in Korea. J Diabetes Investig 2014;5:701-8.
Sivitz WI, Phillips LS, Wexler DJ, Fortmann SP, Camp AW, Tiktin M, et al
. Optimization of metformin in the GRADE cohort: Effect on glycemia and body weight. Diabetes Care 2020;43:940-7.
Al-Aziz MF, Shady MA, El-Hamid SA. Safety and efficacy of fixed dose combination of glimepiride and metformin in type 2 diabetic patients in Egypt: A real-life study. Med J Cairo Univ 2018;86:2599-603.
Prasanna Kumar KM, Seshadri K, Aravind SR, Deb P, Modi KD, Gopal RA, et al
. Real-world observational study of glimepiride and metformin fixed-dose combination along with insulin in the management of type 2 diabetes mellitus: Indian experience. Cureus 2021;13:e13020.
Banset A, Mahato B, Shrestha BL, Bhattarai L, Shrestha MR, Shah RD, et al
. Efficacy and safety of low dose glimepiride – Metformin fixed dose combination [0.5 mg glimepiride +500 mg metformin sustained release (SR)] in patients with type 2 diabetes mellitus (T2DM) in Nepal. Indian Medical Gazette 2019;CLIII: 94-8.
Pantalone KM, Kattan MW, Yu C, Wells BJ, Arrigain S, Jain A, et al
., The risk of overall mortality in patients with type 2 diabetes receiving glipizide, glyburide, or glimepiride monotherapy: A retrospective analysis. Diabetes Care 2010;33:1224-9.
Rosenstock J, Kahn SE, Johansen OE, Zinman B, Espeland MA, Woerle HJ, et al
. Effect of linagliptin vs. glimepiride on major adverse cardiovascular outcomes in patients with type 2 diabetes: The CAROLINA randomized clinical trial. JAMA 2019;322:1155-66.
Vaccaro O, Masulli M, Nicolucci A, Bonora E, Del Prato S, Maggioni AP, et al
. Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): A randomised, multicentre trial. Lancet Diabetes Endocrinol 2017;5:887-97.
[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8]
[Table 1], [Table 2], [Table 3], [Table 4]