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

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 -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% [/ = 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% (/ = 1122/6236) participants had controlled glycemia (HbA1c < 53 mmol/mol, <7%). Macrovascular and microvascular complications were prevalent in 2.3% (/ = 145/6236) and 14.5% (/ = 902/6236) participants, respectively. Among those with complications, non-fatal myocardial infarction (/ = 74/145, 51.0%) and neuropathy (/ = 737/902, 81.7%) were the most reported macrovascular and microvascular complication, respectively. Hypertension (/ = 2566/3281, 78.2%) and dyslipidemia (/ = 1635/3281, 49.8%) were the most reported cardiovascular risks. Majority (74.5%; / = 4643/6236) were taking oral anti-diabetic drugs (OADs) only, while 24.4% (/ = 1522/6236) participants were taking OADs+insulin. Biguanides (/ = 5796/6236, 92.9%) and sulfonylureas (/ = 4757/6236, 76.3%) were the most reported OADs. Basal (/ = 837/6236, 13.4%) and premix (/ = 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.