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

• Published in: Endocrinology, diabetes & metabolism Vol. 4; no. 3; pp. e00231 - n/a
• Main Authors: Das, Ashok K., Mithal, Ambrish, Joshi, Shashank, Kumar, K. M. Prasanna, Kalra, Sanjay, Unnikrishnan, A. G., Thacker, Hemant, Sethi, Bipin, Ghosh, Romik, Kanade, Vaishali, Nair, Arjun, Mohanasundaram, Senthilnathan, Menon, Shalini K., Chodankar, Deepa, Salvi, Vaibhav, Trivedi, Chirag, Chatterjee, Godhuli, Chowdhury, Subhankar, Rais, Nadeem, Wangnoo, Subhash K., Zargar, Abdul H.
• Format: Journal Article
• Language: English
• Published: England John Wiley & Sons, Inc 01.07.2021; John Wiley and Sons Inc; Wiley
• Subjects: Adult; baseline characteristics; Data collection; Demographics; Diabetes; diabetes management; Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - epidemiology; diabetic complications; Disease; Ethics; Glucose; Glycated Hemoglobin A; Health care; Heart attacks; Hemoglobin; Humans; Hypoglycemic Agents - adverse effects; India; Insulin; Longitudinal Studies; Male; Middle Aged; Original; Original s; Population; Prospective Studies; Standard deviation; Values; Southeast Asia; India; diabetic complications; diabetes management; diabetes; India; baseline characteristics
• ISSN: 2398-9238; 2398-9238
• DOI: 10.1002/edm2.231

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 sulfonylureas (n/N = 4757/6236, 76.3%) were the most reported OADs. Basal (n/N = 837/6236, 13.4%) and premix (n/N = 684/6236, 11.0%) insulins were the most reported insulins. Conclusions Baseline data from LANDMARC help understand the clinical/medical profile of study participants and underscore the extent of suboptimal glycemic control and prevalence of associated complications in a vast majority of Indians with T2DM. People with long‐standing diabetes are at an increased risk of diabetes complications and cardiovascular events. In India, progression of diabetes and its complications over a long time has not been studied extensively. The LongitudinAl Nationwide stuDy on Management And Real‐world outComes of diabetes (LANDMARC) study has enrolled 6279 people with type 2 diabetes across India and will prospectively gather data on disease control, treatment, concomitant complications, and risks in these participants over 3years. LANDMARC baseline data represent the real‐world snapshot of a type 2 diabetic profile and underscore poor glycemic control and a considerable burden of complications prevalent in India.