PMID- 34277959 OWN - NLM STAT- MEDLINE DCOM- 20220314 LR - 20221207 IS - 2398-9238 (Electronic) IS - 2398-9238 (Linking) VI - 4 IP - 3 DP - 2021 Jul TI - 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. PG - e00231 LID - 10.1002/edm2.231 [doi] LID - e00231 AB - 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 /=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. CI - (c) 2021 Sanofi. Published by John Wiley & Sons Ltd. FAU - Das, Ashok K AU - Das AK AUID- ORCID: 0000-0003-1770-1885 AD - Pondicherry Institute of Medical Sciences (PIMS Puducherry India. FAU - Mithal, Ambrish AU - Mithal A AD - Medanta - The Medicity Gurgaon India. FAU - Joshi, Shashank AU - Joshi S AD - Lilavati Hospital Mumbai India. FAU - Kumar, K M Prasanna AU - Kumar KMP AD - Centre for Diabetes and Endocrine Care Bengaluru India. FAU - Kalra, Sanjay AU - Kalra S AUID- ORCID: 0000-0003-1308-121X AD - Bharti Hospital Karnal India. FAU - Unnikrishnan, A G AU - Unnikrishnan AG AD - Chellaram Diabetes Institute Pune India. FAU - Thacker, Hemant AU - Thacker H AD - Bhatia Hospital Mumbai India. FAU - Sethi, Bipin AU - Sethi B AD - Care Hospitals Hyderabad India. FAU - Ghosh, Romik AU - Ghosh R AUID- ORCID: 0000-0003-4364-2671 AD - Sanofi India Ltd Mumbai India. FAU - Kanade, Vaishali AU - Kanade V AD - Sanofi-Synthelabo India Ltd Mumbai India. FAU - Nair, Arjun AU - Nair A AD - Sanofi India Ltd Mumbai India. FAU - Mohanasundaram, Senthilnathan AU - Mohanasundaram S AD - Sanofi India Ltd Mumbai India. FAU - Menon, Shalini K AU - Menon SK AD - Sanofi India Ltd Mumbai India. FAU - Chodankar, Deepa AU - Chodankar D AD - Sanofi-Synthelabo India Ltd Mumbai India. FAU - Salvi, Vaibhav AU - Salvi V AD - Sanofi-Synthelabo India Ltd Mumbai India. FAU - Trivedi, Chirag AU - Trivedi C AD - Sanofi-Synthelabo India Ltd Mumbai India. FAU - Chatterjee, Godhuli AU - Chatterjee G AD - Sanofi-Synthelabo India Ltd Mumbai India. FAU - Chowdhury, Subhankar AU - Chowdhury S AD - IPGME & R and SSKM Hospital Kolkata India. FAU - Rais, Nadeem AU - Rais N AD - Chowpatti Medical Centre Mumbai India. FAU - Wangnoo, Subhash K AU - Wangnoo SK AD - Apollo Hospital Education and Research Foundation New Delhi India. FAU - Zargar, Abdul H AU - Zargar AH AD - Center for Diabetes & Endocrine Care Srinagar India. LA - eng SI - CTRI/CTRI/2017/05/008452 PT - Journal Article PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20210208 PL - England TA - Endocrinol Diabetes Metab JT - Endocrinology, diabetes & metabolism JID - 101732442 RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) SB - IM MH - Adult MH - *Diabetes Mellitus, Type 2/complications/drug therapy/epidemiology MH - Glycated Hemoglobin MH - Humans MH - Hypoglycemic Agents/adverse effects MH - Longitudinal Studies MH - Male MH - Middle Aged MH - Prospective Studies PMC - PMC8279635 OTO - NOTNLM OT - *India OT - *baseline characteristics OT - *diabetes OT - *diabetes management OT - *diabetic complications COIS- 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, 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, Boehringer Ingelheim (BI), and MSD. RG, AN, SM, SKM, VK, DC, VS, CT, and GC are employees of Sanofi. 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. EDAT- 2021/07/20 06:00 MHDA- 2022/03/15 06:00 PMCR- 2021/02/08 CRDT- 2021/07/19 06:03 PHST- 2020/11/19 00:00 [received] PHST- 2021/01/08 00:00 [revised] PHST- 2021/01/09 00:00 [accepted] PHST- 2021/07/19 06:03 [entrez] PHST- 2021/07/20 06:00 [pubmed] PHST- 2022/03/15 06:00 [medline] PHST- 2021/02/08 00:00 [pmc-release] AID - EDM2231 [pii] AID - 10.1002/edm2.231 [doi] PST - epublish SO - Endocrinol Diabetes Metab. 2021 Feb 8;4(3):e00231. doi: 10.1002/edm2.231. eCollection 2021 Jul.