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Observational Study
. 2023 Sep;6(5):e422.
doi: 10.1002/edm2.422. Epub 2023 Jul 1.

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

Ashok K Das  1 , Sanjay Kalra  2 , Shashank Joshi  3 , Ambrish Mithal  4 , K M Prasanna Kumar  5 , A G Unnikrishnan  6 , Hemant Thacker  7 , Bipin Sethi  8 , Subhankar Chowdhury  9 , Amarnath Sugumaran  10 , Ashwini Satpathy  10 , Arvind Gadekar  10 , Shalini K Menon  10 , Renuka Neogi  10 , Deepa Chodankar  10 , Chirag Trivedi  10 , S K Wangnoo  11 , A H Zargar  12 , Nadeem Rais  13 ; LANDMARC study group
Affiliations
Observational Study

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

Ashok K Das et al. Endocrinol Diabetes Metab. 2023 Sep.

Abstract

Introduction: LANDMARC (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.

Methods: Participants 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.

Results: Of 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.

Conclusion: These 3-year trends highlight the burden of uncontrolled glycemia and cumulative diabetes-related complications, emphasizing the importance of optimizing diabetes management in India.

Keywords: India; LANDMARC; T2DM; diabetes-related complications; glycemic control; real-world evidence; treatment pattern.

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Conflict of interest statement

AKD, AM, AGU and NR received honoraria from Sanofi and other pharmaceutical companies. KMPK is on the advisory board of Sanofi and received honorarium for his talks. SJ received speaker/advisory/research grants from Abbott, AstraZeneca, Biocon, Boehringer Ingelheim (BI), 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, BI and MSD. 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. SKM, AG, ASugumaran, ASatpathy, RN, DC and CT are/were employees of Sanofi and may hold stock options.

Figures

FIGURE 1
FIGURE 1
Participants disposition.
FIGURE 2
FIGURE 2
Comparison of change in glycemic assessments at 36 months between participants with and without complication at baseline. CI, confidence interval; HbA1c, glycated haemoglobin; FPG, fasting plasma glucose; PPG, postprandial plasma glucose.
FIGURE 3
FIGURE 3
Comparison of change in glycemic control at 36 months between participants with and without complications at baseline. Percentages are based on number of study participants in evaluable population (n = 6222). The data presented as percentage (number of people). *p = .0039, **p = .0241, #p < .0001. HbA1c, glycated haemoglobin.
FIGURE 4
FIGURE 4
Comparison of the use of oral and injectable glucose‐lowering drugs at baseline and 36‐months. AGIs, alpha‐glucosidase inhibitors; DPP‐4i, dipeptidyl peptidase‐4 inhibitors; GLP‐1A, glucagon‐like peptide 1 analogue; SGLT2i, sodium‐glucose cotransporter 2 inhibitors.
See this image and copyright information in PMC

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