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Observational Study
. 2022 Jan;5(1):e00316.
doi: 10.1002/edm2.316. Epub 2021 Dec 1.

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

Ashok K Das  1 , Sanjay Kalra  2 , Shashank Joshi  3 , Ambrish Mithal  4 , Prasanna Kumar K M  5 , Ambika G Unnikrishnan  6 , Hemant Thacker  7 , Bipin Sethi  8 , Subhankar Chowdhury  9 , Romik Ghosh  10 , Sukanya Krishnan  11 , Arjun Nair  10 , Senthilnathan Mohanasundaram  10 , Shalini K Menon  10 , Vaibhav Salvi  11 , Deepa Chodankar  11 , Saket Thaker  11 , Chirag Trivedi  11 , Subhash K Wangnoo  12 , Abdul H Zargar  13 , Nadeem Rais  14
Affiliations
Observational Study

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

Ashok K Das et al. Endocrinol Diabetes Metab. 2022 Jan.

Abstract

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.

Keywords: India; diabetes mellitus; glycaemic control; real-world outcomes.

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Conflict of interest statement

AKD, AM, AGU and NR received honoraria from Sanofi and other pharmaceutical companies. PKKM is on the advisory board of Sanofi and received honorarium for his talks. SJAQ6 received speaker/advisory/research grants from Abbott, Astrazeneca, Biocon, Boeringher Ingelheim, Eli Lilly, Franco Indian, Glenmark, Lupin, Marico, MSD, Novartis, Novo Nordisk, Roche, Sanofi, Serdia, Twinhealth and Zydus. SK received honoraria/speaker fees from Eli Lilly, Novo Nordisk and Sanofi. HT received honoraria from MSD, Novartis, Sanofi, and from other companies for advice and lectures. BS received honorarium from Aventis, Novo Nordisk, Eli Lilly, Boeringher‐Ingelham (BI) and MSD. RG and SK were Sanofi employees; and AN, SM, SKM, DC, VS, ST and CT are employees of Sanofi and may hold stock options. SC received honoraria/grants from Biocon, BI, Intas, Novartis, Sanofi, and Serdia. SKW has nothing to declare. AHZ received honoraria from Novo Nordisk, Eli Lilly, Johnson & Johnson, AstraZeneca, BI and Sanofi.

Figures

FIGURE 1
FIGURE 1
Participants disposition. n = number of participants
FIGURE 2
FIGURE 2
Change in glycaemic parameters at the end of 1 year. Values are presented as mean ± standard deviation. FPG, fasting plasma glucose; HbA1c, glycated haemoglobin; n, number of participants analysed; PPG, postprandial glucose
See this image and copyright information in PMC

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