Published: 2022-09-22

Real-world observational study to capture demographic details of newly diagnosed type 2 diabetes mellitus

Nishant Dalal, Dixit Patel, Alok Chaturvedi, Ankita Shah


Background: To understand the demographic profile of newly diagnosed type 2 diabetes mellitus (T2DM) patients and to evaluate the glycaemic status and initial treatment choices in this subset of T2DM patients.

Methods: The ROD-IT-2 study was a real-world, retrospective, cross-sectional, observational study conducted at various centres across India between April 2021 and March 2022. The study outcomes included epidemiology, comorbidities, and management strategies preferred by Indian clinicians in these patients.

Results: Data from 29,550 newly diagnosed T2DM patients were analyzed. The mean age of patients was 53.3 years, and majority were males (65%). Majority of patients (63.85%) were aged 40 to 60 years. More than half (53.11%) of the patients were either overweight (36.65%) or obese (16.76%). The mean glycated hemoglobin (HbA1c) was high (8.4%). Most (88.5%) patients had cardio-renal comorbidities. Hypertension was the most common comorbidity (45.7%) followed by dyslipidemia (32.1%). Chronic kidney disease (CKD) was also present in 31.2% patients. In the present study, 9.2% patients presented with microvascular complications at the time of diagnosis. Majority of newly diagnosed patients (79.7%) were treated with combination therapy. In patients who were prescribed dual drug combination therapy, metformin + dipeptidyl peptidase-4 inhibitor (DPP4i) was the preferred combination (42.71%)  followed by metformin + sulfonylurea (31.37%).

Conclusions: ROD-IT-2 study showed that mean HbA1c levels in T2DM patients still remain high in our population and cardio-renal comorbidities remain prevalent in newly diagnosed patients. Indian clinicians were found to prefer the combination therapy in newly diagnosed T2DM patients.


Diabetes mellitus, Newly diagnosed, Epidemiology, Complications, Management

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Parikh NI, Hwang S-J, Larson MG, Meigs JB, Levy D, Fox CS. Cardiovascular disease risk factors in chronic kidney disease: overall burden and rates of treatment and control. Arch Intern Med. 2006;166:1884-91.

Rogers WJ, Canto JG, Lambrew CT, Tiefenbrunn AJ, Kinkaid B, Shoultz DA et al. Temporal trends in the treatment of over 1.5 million patients with myocardial infarction in the US from 1990 through 1999: the National Registry of Myocardial Infarction 1, 2 and 3. J Am Coll Cardiol. 2000;36:2056-63.

Pradeepa R, Mohan V. Epidemiology of type 2 diabetes in India. Ind J Ophthal. 2021;69:2932-8.

International Diabetes Federation. Diabetes Atlas, 9th edn. 2019.

Tao Z, Shi A, Zhao J. Epidemiological perspectives of diabetes. Cell Biochem Biophys. 2015;73:181-5.

Anjana R, Pradeepa R, Deepa M, Datta M, Sudha V, Unnikrishnan R et al. Prevalence of diabetes and prediabetes (impaired fasting glucose and/or impaired glucose tolerance) in urban and rural India: Phase I results of the Indian Council of Medical Research–INdia DIABetes (ICMR-INDIAB) study. Diabetologia. 2011;54:3022-7.

Anjana RM, Deepa M, Pradeepa R, Mahanta J, Narain K, Das HK et al. Prevalence of diabetes and prediabetes in 15 states of India: results from the ICMR–INDIAB population-based cross-sectional study. Lancet Diabetes Endocrinol. 2017;5:585-96.

Sattar N, Gill JM. Type 2 diabetes in migrant south Asians: mechanisms, mitigation, and management. Lancet Diabetes Endocrinol. 2015;3:1004-16.

Pradeepa R, Mohan V. Prevalence of type 2 diabetes and its complications in India and economic costs to the nation. Euro J Clin Nutri. 2017;71:816-24.

Tripathy JP. Burden and risk factors of diabetes and hyperglycemia in India: findings from the Global Burden of Disease Study 2016. Diabetes Metab Syndr Obes. 2018;11:381.

Arnold SV, Kosiborod M, Wang J, Fenici P, Gannedahl G, LoCasale RJ. Burden of cardio‐renal‐metabolic conditions in adults with type 2 diabetes within the Diabetes Collaborative Registry. Diabetes Obes Metab. 2018;20:2000-3.

Gregg EW, Sattar N, Ali MK. The changing face of diabetes complications. Lancet Diabetes Endocrinol. 2016;4:537-47.

Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015;38:140-9.

Pradeepa R, Chella S, Surendar J, Indulekha K, Anjana RM, Mohan V. Prevalence of peripheral vascular disease and its association with carotid intima-media thickness and arterial stiffness in type 2 diabetes: the Chennai urban rural epidemiology study (CURES 111). Diab Vasc Dis Res. 2014;11:190-200.

Unnikrishnan R, Rema M, Pradeepa R, Deepa M, Shanthirani CS, Deepa R et al. Prevalence and risk factors of diabetic nephropathy in an urban South Indian population: the Chennai Urban Rural Epidemiology Study (CURES 45). Diabetes Care. 2007;30:2019-2024.

Rema M, Premkumar S, Anitha B, Deepa R, Pradeepa R, Mohan V. Prevalence of diabetic retinopathy in urban India: the Chennai Urban Rural Epidemiology Study (CURES) eye study, I. Invest Ophthalmol. 2005;46:2328-33.

Cersosimo E, Johnson EL, Chovanes C, Skolnik N. Initiating therapy in patients newly diagnosed with type 2 diabetes: Combination therapy vs a stepwise approach. Diabetes Obes Metab. 2018;20:497-507.

Indian Council of Medical Research. National ethical guidelines for biomedical and health research involving human participants. 2017. Available at: Accessed on [cited 23 Novemner 2021.

Claypool KT, Chung MK, Deonarine A, Gregg EW, Patel CJ. Characteristics of undiagnosed diabetes in men and women under the age of 50 years in the Indian subcontinent: the National Family Health Survey (NFHS-4)/Demographic Health Survey 2015-2016. BMJ Open Diabetes Res Care. 2020;8.

Lascar N, Brown J, Pattison H, Barnett AH, Bailey CJ, Bellary S. Type 2 diabetes in adolescents and young adults. Lancet Diabetes Endocrinol. 2018;6:69-80.

Das AK, Gandhi P, Saboo B, Reddy S, Chawla R, Zargar AH et al. Optimizing the treatment of newly diagnosed type 2 diabetes mellitus with combination of dipeptidyl peptidase-4 inhibitors and metformin: An expert opinion. J Family Med Prim Care. 2021;10:4398-409.

Fried M, Yumuk V, Oppert JM, Scopinaro N, Torres AJ, Weiner R et al. Interdisciplinary European Guidelines on metabolic and bariatric surgery. Obes Facts. 2013;6:449-68.

Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA. 2012;307:491-7.

Dyson PA. The therapeutics of lifestyle management on obesity. Diabetes Obes Metab. 2010;12:941-6.

Leitner DR, Frühbeck G, Yumuk V, Schindler K, Micic D, Woodward E et al. Obesity and type 2 diabetes: two diseases with a need for combined treatment strategies-EASO can lead the way. Obes Facts. 2017;10:483-92.

Hossain P, Kawar B, El Nahas M. Obesity and diabetes in the developing world-a growing challenge. N Eng J Med. 2007;356:213-5.

Oldridge NB, Stump TE, Nothwehr FK, Clark DO. Prevalence and outcomes of comorbid metabolic and cardiovascular conditions in middle-and older-age adults. J Clin Epidemiol. 2001;54:928-34.

Garg DK, Dutta MK. Body Mass composition among Underweight Type 2 Diabetes Mellitus Patients-A Cross-sectional Comparative Study. Indian J Endocrinol Metab. 2019;23:222-6.

Willi C, Bodenmann P, Ghali WA, Faris PD, Cornuz J. Active smoking and the risk of type 2 diabetes: a systematic review and meta-analysis. JAMA. 2007;298:2654-64.

De Cosmo S, Viazzi F, Pacilli A, Giorda C, Ceriello A, Gentile S et al. Predictors of chronic kidney disease in type 2 diabetes: a longitudinal study from the AMD Annals initiative. Medicine. 2016;95.

Afkarian M, Sachs MC, Kestenbaum B, Hirsch IB, Tuttle KR, Himmelfarb J et al. Kidney disease and increased mortality risk in type 2 diabetes. J Am Soc Nephrol. 2013;24:302-8.

Lytvyn Y, Godoy LC, Scholtes RA, van Raalte DH, Cherney DZ. Mineralocorticoid antagonism and diabetic kidney disease. Curr Diab Rep. 2019;19:1-10.

Rosenstock J, Perkovic V, Johansen OE, Cooper ME, Kahn SE, Marx N et al. Effect of linagliptin vs placebo on major cardiovascular events in adults with type 2 diabetes and high cardiovascular and renal risk: the CARMELINA randomized clinical trial. JAMA. 2019;321:69-79.

Zelniker TA, Wiviott SD, Raz I, Im K, Goodrich EL, Furtado RH et al. Comparison of the effects of glucagon-like peptide receptor agonists and sodium-glucose cotransporter 2 inhibitors for prevention of major adverse cardiovascular and renal outcomes in type 2 diabetes mellitus: systematic review and meta-analysis of cardiovascular outcomes trials. Circulation. 2019;139:2022-31.