Introduction: Longitudinal data on progression, complications, and management of type 2 diabetes mellitus (T2DM) across India are scarce. LANDMARC (CTRI/2017/05/008452), the first pan-India, longitudinal, prospective, observational study, aims to understand the management and real-world outcomes of T2DM over 3 years.Methods: Adults (≥25 to ≤60 years old at T2DM diagnosis; diabetes duration ≥2 years at enrollment; controlled/uncontrolled on ≥2 anti-diabetic agents) were enrolled.Baseline characteristics were analyzed using descriptive statistics.Results: Of the 6279 recruited participants, 6236 were eligible for baseline assessment (56.6% [n/N = 3528/6236] men; mean ± SD age: 52.1 ± 9.2 years, diabetes duration: 8.6 ± 5.6 years). mean ± SD HbA1c, fasting plasma glucose, and postprandial glucose values were 64 ± 17 mmol/mol (8.1 ± 1.6%), 142.8 ± 50.4 mg/dl, and 205.7 ± 72.3 mg/dl, respectively. Only 25.1% (n/N = 1122/6236) participants had controlled glycemia (HbA1c < 53 mmol/mol, <7%). Macrovascular and microvascular complications were prevalent in 2.3% (n/N = 145/6236) and 14.5% (n/N = 902/6236) participants, respectively. Among those with complications, non-fatal myocardial infarction (n/N = 74/145, 51.0%) and neuropathy (n/N = 737/902, 81.7%) were the most reported macrovascular and microvascular complication, respectively. Hypertension (n/N = 2566/3281, 78.2%) and dyslipidemia (n/N = 1635/3281, 49.8%) were the most reported cardiovascular risks. Majority (74.5%; n/N = 4643/6236) were taking oral anti-diabetic drugs (OADs) only, while 24.4% (n/N = 1522/6236) participants were taking OADs+insulin. Biguanides (n/N = 5796/6236, 92.9%) and sulfonylureasThis is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
Introduction Longitudinal data on management and progression of type 2 diabetes mellitus (T2DM) in India are scarce. LANDMARC (CTRI/2017/05/008452), first‐of‐its‐kind, pan‐India, prospective, observational study aimed to evaluate real‐world patterns and management of T2DM over 3 years. Methods Adults (≥25 to ≤60 years old at T2DM diagnosis; diabetes duration ≥2 years at enrolment; controlled/uncontrolled on ≥2 anti‐diabetic agents) were enrolled. The first‐year trends for glycaemic control, therapy and diabetic complications, including those from metropolitan and non‐metropolitan cities are reported here. Results Of 6236 enrolled participants, 5654 completed 1 year in the study. Although the overall mean glycated haemoglobin (HbA1c) improved by 0.5% (baseline: 8.1%) at 1 year, only 20% of the participants achieved HbA1c <7%. Participants from metropolitan and non‐ metropolitan cities showed similar decrease in glycaemic levels (mean change in HbA1c: −0.5% vs. −0.5%; p = .8613). Among diabetic complications, neuropathy was the predominant complication (815/6236, 13.1% participants). Microvascular complications (neuropathy, nephropathy and retinopathy) were significantly (p < .0001) higher in non‐metropolitan than metropolitan cities. Hypertension (2623/6236, 78.2%) and dyslipidaemia (1696/6236, 50.6%) continued to be the most commonly reported cardiovascular risks at 1 year. After 1 year, majority of the participants were taking only oral anti‐diabetic drugs (OADs) (baseline: 4642/6236 [74.4%]; 1 year: 4045/6013 [67.3%]), while the proportion of those taking insulin along with OADs increased (baseline: 1498/6236 [24.0%] vs. 1 year: 1844/6013 [30.7%]). Biguanides and sulfonylureas were the most used OADs. The highest increase in use was seen for dipeptidyl peptidase‐IV inhibitors (baseline: 3047/6236 [48.9%]; 1 year: 3529/6013 [58.7%]). Improvement in all glycaemic parameters was significantly (p < .0001) higher in the insulin vs. the insulin‐naïve subgroups; in the insulin‐naïve subgroup, no statistical difference was noted in those who received >3 vs. ≤3 OADs. Conclusions First‐year trends of the LANDMARC study offer insights into real‐world disease progression, suggesting the need for controlling risk factors and timely treatment intensification in people with T2DM.
There are few studies on type 2 diabetes complications from Indian metropolitan and non-metropolitan cities. Macrovascular and microvascular complications during the second year of LANDMARC, a 3-year nationwide prospective observational study (CTRI/2017/05/008452) , were evaluated in participants from metropolitan versus non-metropolitan cities. LANDMARC included participants with T2D who were on ≥2 antihyperglycemic medications. Of the total 6234 participants, 2376 and 3858 were from metropolitan and non-metropolitan cities, respectively. Age, T2D duration, and baseline A1C were similar across groups. Microvascular complications were significantly higher in participants from non-metropolitan than metropolitan cities (12.93% vs. 4.65%; p<0.0001) during the 2 years. Neuropathy was the most common microvascular complication in both metropolitan and non-metropolitan cities. Among macrovascular complications, a greater number of participants reported heart failure (p=0.0160) and CV deaths in non-metropolitan cities than metropolitan cities (Table) . The present data from India demonstrates that participants from non-metropolitan cities may have higher complications, particularly microvascular, and may need to be better understood through future studies. The LANDMARC results elicit a pattern of disease progression among participants with T2D. Disclosure S. Kalra: Speaker's Bureau; Boehringer Ingelheim International GmbH, Novo Nordisk A/S, Sanofi. A.K. Das: Advisory Panel; Boehringer Ingelheim International GmbH, Novo Nordisk, Roche Diagnostics, Sanofi. Speaker's Bureau; Dr. Reddy’s Laboratories Ltd., Lupin Pharmaceuticals, Inc., USV Private Limited. S. Joshi: Advisory Panel; Abbott, Boehringer Ingelheim International GmbH, Dr. Reddy's Laboratories Ltd., Eli Lilly and Company, Novo Nordisk, Roche Diabetes Care. Consultant; Biocon, Glenmark Pharmaceuticals, Sanofi, USV Private Limited. A. Mithal: Advisory Panel; Eris Lifesciences Ltd. Consultant; Glenmark Pharmaceuticals, Lupin Pharmaceuticals, Inc., USV Private Limited. Speaker's Bureau; Abbott Diabetes, AstraZeneca, Biocon, Boehringer Ingelheim International GmbH, Dr. Reddy’s Laboratories Ltd., Novartis AG, Novo Nordisk, Sanofi. K. Kumar: None. A. Unnikrishnan: Advisory Panel; Intas Pharmaceuticals Ltd. Speaker's Bureau; Abbott, AstraZeneca, Boehringer-Ingelheim, Sanofi. Other Relationship; Novo Nordisk, Serdia Pharmaceuticals (India) Pvt. Ltd., Torrent Pharmaceuticals Ltd. H. Thacker: None. B. Sethi: None. S. Chowdhury: None. A. Nair: None. S. Mohanasundaram: Employee; Sanofi. V. Salvi: Employee; Sanofi. D. Chodankar: Employee; Sanofi. C. Trivedi: None. S. Wangnoo: None. A.H. Zargar: Advisory Panel; Sanofi. Speaker's Bureau; AstraZeneca, Biocon, Boehringer Ingelheim International GmbH, Intas Pharmaceuticals Ltd., Janssen Pharmaceuticals, Inc., Lupin Pharmaceuticals, Inc., Novo Nordisk, USV Private Limited. N. Rais: None. Funding Sanofi, India
Macrovascular and microvascular complications were evaluated during the first 2 years of LANDMARC, a 3-year prospective observational study (CTRI/2017/05/008452) that included participants with T2D on ≥2 antihyperglycemic medications. Out of 6234 evaluable participants (mean baseline values - age: 52.1 years, T2D duration: 8.59 years and A1C: 8.05%) , 5318 participants completed the 2-year follow-up. The mean A1C decreased by 0.58% (baseline: 8.05%) in 2 years. The microvascular complications were frequent in 17.6% participants (1096/6234) ; while the incidence of macrovascular complications was 1.1% participants (66/6234) . Neuropathy was the most commonly reported complication (baseline: 11.8% and 2-years: 14.4%) . Overall, complications were more common in participants with BMI ≥23 kg/m2, A1C ≥7% or having CV risk factors (Table) . A total of 41 deaths were reported; of which 30 deaths were attributed to CV causes (sudden death [n=19], myocardial infarction [n=9], stroke [n=1], and coronary artery procedure [n=1]) . The 2-year results indicate more complications among those who were overweight, or with suboptimal glycemic control or having CV risk factors. Neuropathy was the predominant T2D complication. These results offer insights into disease progression and suggest the need for controlling risk factors and timely treatment adjustment in participants with T2D. Disclosure N. Rais: None. A.K. Das: Advisory Panel; Boehringer Ingelheim International GmbH, Novo Nordisk, Roche Diagnostics, Sanofi. Speaker's Bureau; Dr. Reddy’s Laboratories Ltd., Lupin Pharmaceuticals, Inc., USV Private Limited. S. Joshi: Advisory Panel; Abbott, Boehringer Ingelheim International GmbH, Dr. Reddy’s Laboratories Ltd., Eli Lilly and Company, Novo Nordisk, Roche Diabetes Care. Consultant; Biocon, Glenmark Pharmaceuticals, Sanofi, USV Private Limited. A. Mithal: Advisory Panel; Eris Lifesciences Ltd. Consultant; Glenmark Pharmaceuticals, Lupin Pharmaceuticals, Inc., USV Private Limited. Speaker's Bureau; Abbott Diabetes, AstraZeneca, Biocon, Boehringer Ingelheim International GmbH, Dr. Reddy’s Laboratories Ltd., Novartis AG, Novo Nordisk, Sanofi. S. Kalra: Speaker's Bureau; Boehringer Ingelheim International GmbH, Novo Nordisk A/S, Sanofi. A. Unnikrishnan: Advisory Panel; Intas Pharmaceuticals Ltd. Speaker's Bureau; Abbott, AstraZeneca, Boehringer-Ingelheim, Sanofi. Other Relationship; Novo Nordisk, Serdia Pharmaceuticals (India) Pvt. Ltd., Torrent Pharmaceuticals Ltd. H. Thacker: None. B. Sethi: None. S. Chowdhury: None. A. Nair: None. S. Mohanasundaram: Employee; Sanofi. V. Salvi: Employee; Sanofi. D. Chodankar: Employee; Sanofi. C. Trivedi: None. S. Wangnoo: None. A.H. Zargar: Advisory Panel; Sanofi. Speaker's Bureau; AstraZeneca, Biocon, Boehringer Ingelheim International GmbH, Intas Pharmaceuticals Ltd., Janssen Pharmaceuticals, Inc., Lupin Pharmaceuticals, Inc., Novo Nordisk, USV Private Limited. K. Kumar: None. Funding Sanofi, India
Glycemic change from baseline to 2-years was examined during the second year of LANDMARC, a 3-year prospective observational study (CTRI/2017/05/008452) , which included participants with T2D taking ≥2 antihyperglycemic medications (with/without glycemic control) . Out of 6234 evaluable participants (mean baseline values - age: 52.1 years, T2D duration: 8.59 years and A1C: 8.05%) , 5318 completed 2-year follow-up visit. All glycemic parameters improved significantly (p<0.0001) from baseline (A1C: -0.58 % [1.67]; FPG: -14.60 mg/dL [54.54]; and PPG -21.96 mg/dL [78.99]) . From baseline to the end of 2 years, the number of participants in the 7-7.9% A1C subgroup increased in comparison to higher A1C subgroups; but only 20.8% (1297/6234) achieved optimum glycemic control of A1C <7%. Suboptimal glycemic control was observed in the subgroups with cardiovascular risk factors, and microvascular and macrovascular complications (Table) . In conclusion, although there was a marked improvement in all the glycemic parameters from baseline, a large majority of the participants remained uncontrolled. This emphasizes the need for optimizing diabetes management in India. Disclosure S. Joshi: Advisory Panel; Abbott, Boehringer Ingelheim International GmbH, Dr. Reddy’s Laboratories Ltd., Eli Lilly and Company, Novo Nordisk, Roche Diabetes Care. Consultant; Biocon, Glenmark Pharmaceuticals, Sanofi, USV Private Limited. A.K. Das: Advisory Panel; Boehringer Ingelheim International GmbH, Novo Nordisk, Roche Diagnostics, Sanofi. Speaker's Bureau; Dr. Reddy’s Laboratories Ltd., Lupin Pharmaceuticals, Inc., USV Private Limited. K. Kumar: None. A. Mithal: Advisory Panel; Eris Lifesciences Ltd. Consultant; Glenmark Pharmaceuticals, Lupin Pharmaceuticals, Inc., USV Private Limited. Speaker's Bureau; Abbott Diabetes, AstraZeneca, Biocon, Boehringer Ingelheim International GmbH, Dr. Reddy’s Laboratories Ltd., Novartis AG, Novo Nordisk, Sanofi. S. Kalra: Speaker's Bureau; Boehringer Ingelheim International GmbH, Novo Nordisk A/S, Sanofi. A. Unnikrishnan: Advisory Panel; Intas Pharmaceuticals Ltd. Speaker's Bureau; Abbott, AstraZeneca, Boehringer-Ingelheim, Sanofi. Other Relationship; Novo Nordisk, Serdia Pharmaceuticals (India) Pvt. Ltd., Torrent Pharmaceuticals Ltd. H. Thacker: None. B. Sethi: None. S. Chowdhury: None. A. Nair: None. S. Mohanasundaram: Employee; Sanofi. V. Salvi: Employee; Sanofi. D. Chodankar: Employee; Sanofi. C. Trivedi: None. S. Wangnoo: None. A.H. Zargar: Advisory Panel; Sanofi. Speaker's Bureau; AstraZeneca, Biocon, Boehringer Ingelheim International GmbH, Intas Pharmaceuticals Ltd., Janssen Pharmaceuticals, Inc., Lupin Pharmaceuticals, Inc., Novo Nordisk, USV Private Limited. N. Rais: None. Funding Sanofi, India
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