Shaikh Shehla, Sharma Surendra K, Phatak Sanjeev, Asirvatham Arthur, Bhattacharyya Supratik, Dhandhania Vinay K, Muchhala Sameer, Baxi Niddhi
K. G. N. Diabetes and Endocrinology Centre, Mumbai, India.
Mahatma Gandhi Medical College, Jaipur, India.
Diabetes Ther. 2025 Apr;16(4):645-661. doi: 10.1007/s13300-025-01693-z. Epub 2025 Feb 19.
Imeglimin is a novel oral antidiabetic drug that was approved for use in India in October 2022. Thus far, no large-scale studies on the effectiveness and safety of imeglimin for the treatment of type-2 diabetes mellitus (T2DM) have been conducted in the Indian population. The objective of this study was to evaluate the effectiveness and safety of imeglimin in Indian patients with T2DM in a real-world setting.
This observational, retrospective, real-world study was conducted at 191 sites across India from May to June 2024. Adult patients with uncontrolled T2DM (7% ≤ glycated hemoglobin (HbA1c) ≤ 9%) who were prescribed imeglimin 1000 mg twice a day as part of routine clinical practice, who were either treatment naïve or on other antidiabetic agents, and for whom a valid prescription and required data were available were included in the study. The data were collected from the medical records of eligible subjects and analyzed for the changes in glycemic indices from baseline to the 3-month follow-up.
The data for 8301 patients (male: 59.39%) were analyzed. Of these, 2009 (24.20%) subjects received imeglimin monotherapy and 5004 (60.28%) received dual therapy. The analysis showed a statistically significant (p < 0.0001) reduction from baseline to the 3-month follow-up in glycemic indices and weight. The mean HbA1c, fasting and postprandial plasma glucose, and weight were decreased by 1.12%, 29.41 mg/dL, 62.41 mg/dL, and 2.01 kg, respectively. A total of 3547 (45.35%) subjects achieved HbA1c < 7%. No adverse events were reported.
Imeglimin shows promise as an effective and well-tolerated option for managing T2DM in the Indian population. Also, secondary impacts of imeglimin, such as improvements in the lipid profile, hepatic function, blood pressure, and weight loss, warrant further clinical exploration.
依美格列明是一种新型口服抗糖尿病药物，于2022年10月在印度获批使用。迄今为止，尚未在印度人群中开展关于依美格列明治疗2型糖尿病（T2DM）有效性和安全性的大规模研究。本研究的目的是在真实世界环境中评估依美格列明对印度T2DM患者的有效性和安全性。
本观察性、回顾性、真实世界研究于2024年5月至6月在印度各地的191个地点进行。将糖化血红蛋白（HbA1c）为7%≤HbA1c≤9%且血糖控制不佳的成年T2DM患者纳入研究，这些患者在常规临床实践中被处方每日两次服用1000毫克依美格列明，他们既往未接受过治疗或正在使用其他抗糖尿病药物，且有有效处方和所需数据。从符合条件的受试者的医疗记录中收集数据，并分析从基线到3个月随访期间血糖指标的变化。
分析了8301例患者（男性占59.39%）的数据。其中，2009例（24.20%）受试者接受依美格列明单药治疗，5004例（60.28%）接受联合治疗。分析显示，从基线到3个月随访，血糖指标和体重有统计学意义的降低（p<0.0001）。平均HbA1c、空腹和餐后血糖以及体重分别下降了1.12%、29.41毫克/分升、62.41毫克/分升和2.01千克。共有3547例（45.35%）受试者的HbA1c<7%。未报告不良事件。
依美格列明有望成为印度人群中治疗T2DM的有效且耐受性良好的选择。此外，依美格列明的次要影响，如血脂谱改善、肝功能改善、血压改善和体重减轻，值得进一步临床探索。
