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

摘要

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.