Efficacy and Safety of Glimepiride, Voglibose, and Metformin ER in Type 2 Diabetes: A Randomized, Active-Controlled Study

IF 5.9 2区医学 Q2 ENDOCRINOLOGY & METABOLISM

Journal of Diabetes Pub Date : 2026-04-14 DOI:10.1111/1753-0407.70217

Brij Mohan, S. Vasanth Kumar, Prakash Harishchandra Kurmi, Sandeep Kumar Gupta, Neelaveni Kudugunti, Bharat Das, Kartikeya Parmar, Alok Kanungo, Sanjay Saran, Preetam Ahirrao Kashinath, Balamurugan Ramanathan, Micky Patel, Vivek Vedprakash Arya, Raisa Shaikh, Sapan Behera, Piyush Patel, Dipak Patil, Lalit Lakhwani, Pravin Ghadge, Suyog Mehta, Sadhna Joglekar

{"title":"Efficacy and Safety of Glimepiride, Voglibose, and Metformin ER in Type 2 Diabetes: A Randomized, Active-Controlled Study","authors":"Brij Mohan, S. Vasanth Kumar, Prakash Harishchandra Kurmi, Sandeep Kumar Gupta, Neelaveni Kudugunti, Bharat Das, Kartikeya Parmar, Alok Kanungo, Sanjay Saran, Preetam Ahirrao Kashinath, Balamurugan Ramanathan, Micky Patel, Vivek Vedprakash Arya, Raisa Shaikh, Sapan Behera, Piyush Patel, Dipak Patil, Lalit Lakhwani, Pravin Ghadge, Suyog Mehta, Sadhna Joglekar","doi":"10.1111/1753-0407.70217","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>India ranks second in the global diabetes epidemic, with about 89 million individuals living with Type 2 diabetes mellitus (T2DM). We compared the efficacy and safety of fixed-dose combination (FDC) of glimepiride, voglibose, and extended-release metformin (GLIME+VOGLI+MET-ER) with voglibose and metformin (VOGLI+MET) and glimepiride and metformin (GLIME+MET).</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>A Phase IV, randomized, open-label, active-controlled study was performed in adult patients with T2DM poorly controlled with metformin. Patients received twice daily doses of GLIME+VOGLI+MET-ER (1 + 0.2 + 500 mg: Trivolib 1, 2 + 0.2 + 500 mg: Trivolib 2); or VOGLI+MET (0.2 + 500 mg, 0.3 + 500 mg) or GLIME+MET (1 + 500 mg, 2 + 500 mg). The primary endpoint was the change in HbA1c from baseline.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Of the 458 patients screened, 399 were randomized (GLIME+VOGLI+MET-ER [<i>n</i> = 133], VOGLI+MET (<i>n</i> = 135), and GLIME+MET [<i>n</i> = 131]). The mean baseline HbA1c was ~8.35% (~67.77 mmol/mol). All the treatments showed a significant reduction in HbA1c at Weeks 12 and 24. Mean change in % (mmol/mol) HbA1c was significantly more with GLIME+VOGLI+MET-ER versus VOGLI+MET and GLIME+MET at Week 12 (−1.02 ± 0.60 [−11.2 ± 6.52] vs. −0.68 ± 0.64 [−7.49 ± 6.95], <i>p</i> < 0.001 and −0.88 ± 0.49 [−9.65 ± 5.34], <i>p</i> = 0.0154) and Week 24 (−1.57 ± 0.74 [−17.2 ± 8.14] vs. −1.11 ± 0.80 [−12.2 ± 8.79], <i>p</i> < 0.001 and −1.28 ± 0.60 [−14.0 ± 6.56], <i>p</i> = 0.0002). Overall, 49 adverse events (AEs) were reported in 32/399 (8.0%) patients. One patient each in GLIME+VOGLI+MET-ER and VOGLI+MET groups had level 1 hypoglycemia requiring no management. No severe or serious AEs were reported.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>In adult patients with T2DM inadequately controlled on metformin monotherapy, GLIME+VOGLI+MET-ER demonstrated superior HbA1c reduction compared with VOGLI+MET and GLIME+MET at Weeks 12 and 24. Study medications were safe and well-tolerated.</p>\n \n <p><b>Trial Registration:</b> Clinical Trial Registry India—CTRI/2020/11/029080 [Registered on: 12/11/2020].</p>\n </section>\n </div>","PeriodicalId":189,"journal":{"name":"Journal of Diabetes","volume":"18 4","pages":""},"PeriodicalIF":5.9000,"publicationDate":"2026-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/1753-0407.70217","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Diabetes","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/1753-0407.70217","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}

引用次数: 0

Abstract

Background

India ranks second in the global diabetes epidemic, with about 89 million individuals living with Type 2 diabetes mellitus (T2DM). We compared the efficacy and safety of fixed-dose combination (FDC) of glimepiride, voglibose, and extended-release metformin (GLIME+VOGLI+MET-ER) with voglibose and metformin (VOGLI+MET) and glimepiride and metformin (GLIME+MET).

Methods

A Phase IV, randomized, open-label, active-controlled study was performed in adult patients with T2DM poorly controlled with metformin. Patients received twice daily doses of GLIME+VOGLI+MET-ER (1 + 0.2 + 500 mg: Trivolib 1, 2 + 0.2 + 500 mg: Trivolib 2); or VOGLI+MET (0.2 + 500 mg, 0.3 + 500 mg) or GLIME+MET (1 + 500 mg, 2 + 500 mg). The primary endpoint was the change in HbA1c from baseline.

Results

Of the 458 patients screened, 399 were randomized (GLIME+VOGLI+MET-ER [n = 133], VOGLI+MET (n = 135), and GLIME+MET [n = 131]). The mean baseline HbA1c was ~8.35% (~67.77 mmol/mol). All the treatments showed a significant reduction in HbA1c at Weeks 12 and 24. Mean change in % (mmol/mol) HbA1c was significantly more with GLIME+VOGLI+MET-ER versus VOGLI+MET and GLIME+MET at Week 12 (−1.02 ± 0.60 [−11.2 ± 6.52] vs. −0.68 ± 0.64 [−7.49 ± 6.95], p < 0.001 and −0.88 ± 0.49 [−9.65 ± 5.34], p = 0.0154) and Week 24 (−1.57 ± 0.74 [−17.2 ± 8.14] vs. −1.11 ± 0.80 [−12.2 ± 8.79], p < 0.001 and −1.28 ± 0.60 [−14.0 ± 6.56], p = 0.0002). Overall, 49 adverse events (AEs) were reported in 32/399 (8.0%) patients. One patient each in GLIME+VOGLI+MET-ER and VOGLI+MET groups had level 1 hypoglycemia requiring no management. No severe or serious AEs were reported.

Conclusions

In adult patients with T2DM inadequately controlled on metformin monotherapy, GLIME+VOGLI+MET-ER demonstrated superior HbA1c reduction compared with VOGLI+MET and GLIME+MET at Weeks 12 and 24. Study medications were safe and well-tolerated.

Trial Registration: Clinical Trial Registry India—CTRI/2020/11/029080 [Registered on: 12/11/2020].

Abstract Image

查看原文本刊更多论文

格列美脲、伏格列糖和二甲双胍ER治疗2型糖尿病的疗效和安全性：一项随机、主动对照研究

印度在全球糖尿病患病率中排名第二，约有8900万人患有2型糖尿病（T2DM）。我们比较了格列美脲、伏格列糖和缓释二甲双胍（GLIME+VOGLI+MET- er）与伏格列糖和二甲双胍（VOGLI+MET）和格列美脲和二甲双胍（GLIME+MET）的固定剂量联合（FDC）的疗效和安全性。方法对二甲双胍控制不良的成年T2DM患者进行IV期随机、开放标签、主动对照研究。患者接受每日两次剂量的GLIME+VOGLI+MET-ER (1 + 0.2 + 500mg: Trivolib 1,2 + 0.2 + 500mg: Trivolib 2)；或VOGLI +满足(0.2 + 500毫克,0.3 + 500毫克)或半明冰+满足(1 + 500毫克,2 + 500毫克)。主要终点是HbA1c较基线的变化。在筛选的458例患者中，399例随机分组（GLIME+VOGLI+MET- er [n = 133], VOGLI+MET （n = 135）和GLIME+MET [n = 131]）。平均基线HbA1c为~8.35% （~67.77 mmol/mol）。在第12周和第24周，所有治疗均显示HbA1c显著降低。意味着改变%(更易与摩尔)糖化血红蛋白明显更与半明冰+ VOGLI + MET-ER与VOGLI +遇到和半明冰+在第12周(−1.02±0.60(−11.2±6.52)与−−7.49±6.95,0.68±0.64 p & lt; 0.001和0.88±0.49−−9.65±5.34,p = 0.0154)和24周(−1.57±0.74(−17.2±8.14)与−−12.2±8.79,1.11±0.80 p & lt; 0.001和1.28±0.60−−14.0±6.56,p = 0.0002)。总体而言，32/399（8.0%）患者报告了49例不良事件（ae）。GLIME+VOGLI+MET- er组和VOGLI+MET组各有1例患者出现1级低血糖，无需治疗。没有严重或严重的ae报告。结论：在二甲双胍单药治疗控制不充分的成年T2DM患者中，与VOGLI+MET和GLIME+MET相比，GLIME+VOGLI+MET- er在第12周和第24周表现出更好的HbA1c降低效果。研究药物是安全且耐受性良好的。试验注册：Clinical Trial Registry India-CTRI /2020/11/029080[注册日期：12/11/2020]。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Journal of Diabetes ENDOCRINOLOGY & METABOLISM-

CiteScore

6.50

自引率

2.20%

发文量

审稿时长

>12 weeks

期刊介绍： Journal of Diabetes (JDB) devotes itself to diabetes research, therapeutics, and education. It aims to involve researchers and practitioners in a dialogue between East and West via all aspects of epidemiology, etiology, pathogenesis, management, complications and prevention of diabetes, including the molecular, biochemical, and physiological aspects of diabetes. The Editorial team is international with a unique mix of Asian and Western participation. The Editors welcome submissions in form of original research articles, images, novel case reports and correspondence, and will solicit reviews, point-counterpoint, commentaries, editorials, news highlights, and educational content.