Baseline characteristics of participants in the LANDMARC trial: A 3‐year, <i>pan</i>‐india, prospective, longitudinal study to assess management and real‐world outcomes of diabetes mellitus

et al. 2021

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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.

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

“…The details of the study design, methodology, inclusion/exclusion criteria and statistical analysis have been published previously. 23 , 24 …”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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One‐year trends from the LANDMARC trial: A 3‐year, pan‐India, prospective, longitudinal study on the management and real‐world outcomes of type 2 diabetes mellitus

et al. 2021

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Two‐year trends from the LANDMARC study: A 3‐year, pan‐India, prospective, longitudinal study on the management and real‐world outcome in patients with type 2 diabetes mellitus

et al. 2023

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Introduction There are limited data on the real‐world management of diabetes in the Indian population. In this 2‐year analysis of the LANDMARC study, the management of type 2 diabetes mellitus (T2DM) and related complications were assessed. Method This multicenter, observational, prospective study included adults aged ≥25 to ≤60 years diagnosed with T2DM (duration ≥2 years at enrollment) and controlled/uncontrolled on ≥2 anti‐diabetic agents. This interim analysis at 2 years reports the status of glycaemic control, diabetic complications, cardiovascular (CV) risks and therapy, pan‐India including metropolitan and non‐metropolitan cities. Results Of the 6234 evaluable patients, 5318 patients completed 2 years in the study. Microvascular complications were observed in 17.6% of patients (1096/6234); macrovascular complications were observed in 3.1% of patients (195/6234). Higher number of microvascular complications were noted in patients from non‐metropolitan than in metropolitan cities (p < .0001). In 2 years, an improvement of 0.6% from baseline (8.1%) in mean glycated haemoglobin (HbA1c) was noted; 20.8% of patients met optimum glycaemic control (HbA1c < 7%). Hypertension (2679/3438, 77.9%) and dyslipidaemia (1776/3438, 51.7%) were the predominant CV risk factors in 2 years. The number of patients taking oral anti‐diabetic drugs in combination with insulin increased in 2 years (baseline: 1498/6234 [24.0%] vs. 2 years: 1917/5763 [33.3%]). While biguanides and sulfonylureas were the most commonly prescribed, there was an evident increase in the use of dipeptidyl peptidase‐IV inhibitors (baseline: 3049/6234, 48.9% vs. 2 years: 3526/5763, 61.2%). Conclusion This longitudinal study represents the control of T2DM, its management and development of complications in Indian population. Clinical Trial Registration Number CTRI/2017/05/008452.

The LongitudinAl Nationwide stuDy on Management And Real‐world outComes of diabetes in India over 3 years (LANDMARC trial)

et al. 2023

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IntroductionLANDMARC (CTRI/2017/05/008452), a prospective, observational real‐world study, evaluated the occurrence of diabetes complications, glycemic control and treatment patterns in people with type 2 diabetes mellitus (T2DM) from pan‐India regions over a period of 3 years.MethodsParticipants with T2DM (≥25 to ≤60 years old at diagnosis, diabetes duration ≥2 years at the time of enrollment, with/without glycemic control and on ≥2 antidiabetic therapies) were included. The proportion of participants with macrovascular and microvascular complications, glycemic control and time to treatment adaptation over 36 months were assessed.ResultsOf the 6234 participants enrolled, 5273 completed 3 years follow‐up. At the end of 3‐years, 205 (3.3%) and 1121 (18.0%) participants reported macrovascular and microvascular complications, respectively. Nonfatal myocardial infarction (40.0%) and neuropathy (82.0%) were the most common complications. At baseline and 3‐years, 25.1% (1119/4466) and 36.6% (1356/3700) of participants had HbA1c <7%, respectively. At 3‐years, population with macrovascular and microvascular complications had higher proportion of participants with uncontrolled glycemia (78.2% [79/101] and 70.3% [463/659], respectively) than those without complications (61.6% [1839/2985]). Over 3‐years, majority (67.7%–73.9%) of the participants were taking only OADs (biguanides [92.2%], sulfonylureas [77.2%] and DPP‐IV inhibitors [62.4%]). Addition of insulin was preferred in participants who were only on OADs at baseline, and insulin use gradually increased from 25.5% to 36.7% at the end of 3 years.ConclusionThese 3‐year trends highlight the burden of uncontrolled glycemia and cumulative diabetes‐related complications, emphasizing the importance of optimizing diabetes management in India.