Efficacy and safety of fixed dose combination of Sitagliptin, metformin, and pioglitazone in type 2 Diabetes (IMPACT study): a randomized controlled trial.

Clinical Diabetes and Endocrinology Pub Date : 2024-02-10 DOI:10.1186/s40842-023-00161-6

Mondal Aashish, Naskar Arindam, Sheelu Shafiq Siddiqi, Deepak Bhosle, V J Mallikarjuna, Dange Amol, Sorate Sanket, Gavali Omkar, Patel Parth, Hasnani Dhruvi, Prasad Durga, Dalwadi Pradeep, Kumar Suresh, Pathak Vaishali, Chaudhari Mayura, Basu Indraneel, Shembalkar Jayashri, Fariooqui Arif, S K Raghavendra, Varade Deepak, Thakkar Ravindra, Bhanushali Shaishav, Gaikwad Vijay, Kamran Khan, V V Mahajani, A D Sharma, Mayur Mayabhate, R R Pawar, A S Aiwale, Shahavi Vinayaka

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引用次数: 0

Abstract

Background: Due to the progressive decline in β-cell function, it is often necessary to utilize multiple agents with complementary mechanisms of action to address various facets and achieve glycemic control. Thus, this study aimed to evaluate the efficacy and safety of a fixed-dose combination (FDC) of metformin/sitagliptin/pioglitazone (MSP) therapy vs. metformin/sitagliptin (MS) in type 2 diabetes mellitus (T2DM).

Methods: In this phase 3, multicenter, double-blind study, patients with T2DM who exhibited inadequate glycemic control with HbA1c of 8.0-11.0% while taking ≥1500 mg/day metformin for at least 6 weeks were randomized to receive either FDC of MSP (1000/100/15 mg) or MS (1000/100 mg) per day for 24 weeks. The primary outcome measure was the change in HbA1c, and secondary outcomes included changes in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and body weight from baseline to 24 weeks along with safety and tolerability.

Results: Among the 236 patients randomized, 207 (87.71%) successfully completed the study. All baseline characteristics were comparable between the FDC of MSP and MS groups. There was a subsequent significant reduction of HbA1c in FDC of MSP (- 1.64) vs. MS (- 1.32); between groups was [- 0.32% (95% CI, - 0.59, - 0.05)], P = 0.0208. Similar reductions were found in FPG [- 13.2 mg/dL (95% CI, - 22.86, - 3.71)], P = 0.0068, and PPG [- 20.83 mg/dL (95% CI, - 34.11, - 7.55)], P = 0.0023. There were no significant changes in body weight. A total of 27 adverse effects (AEs) and one severe AE were reported, none of which were related to the study drug.

Conclusion: The FDC of MSP demonstrated significant efficacy in managing glycemic indices and could serve as a valuable tool for physicians in the management of Indian patients with T2DM.

Trial registration: Clinical Trials Registry of India, CTRI/2021/10/037461.

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西他列汀、二甲双胍和吡格列酮固定剂量组合治疗 2 型糖尿病的有效性和安全性（IMPACT 研究）：随机对照试验。

背景：由于β细胞功能逐渐衰退，通常需要使用多种具有互补作用机制的药物来解决不同方面的问题并实现血糖控制。因此，本研究旨在评估二甲双胍/沙格列汀/吡格列酮固定剂量联合疗法（FDC）与二甲双胍/沙格列汀固定剂量联合疗法（MSP）在2型糖尿病（T2DM）中的疗效和安全性：在这项3期多中心双盲研究中，每天服用二甲双胍≥1500毫克至少6周、血糖控制不佳（HbA1c为8.0-11.0%）的T2DM患者被随机分配到每天服用MSP（1000/100/15毫克）或MS（1000/100毫克）的FDC中，为期24周。主要结果指标是 HbA1c 的变化，次要结果包括从基线到 24 周期间空腹血浆葡萄糖 (FPG)、餐后血浆葡萄糖 (PPG) 和体重的变化，以及安全性和耐受性：在随机抽取的 236 名患者中，207 人（87.71%）成功完成了研究。MSP FDC 组和 MS 组的所有基线特征均相当。MSP FDC 组（- 1.64）与 MS 组（- 1.32）相比，HbA1c 有明显下降；组间降幅为[- 0.32% (95% CI, - 0.59, - 0.05)]，P = 0.0208。FPG [- 13.2 mg/dL (95% CI, - 22.86, - 3.71)]（P = 0.0068）和 PPG [- 20.83 mg/dL (95% CI, - 34.11, - 7.55)]（P = 0.0023）的降幅相似。体重没有明显变化。共报告了27例不良反应（AE）和1例严重不良反应，均与研究药物无关：MSP的FDC在控制血糖指数方面具有显著疗效，可作为医生管理印度T2DM患者的重要工具：试验注册：印度临床试验注册中心，CTRI/2021/10/037461。

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来源期刊

Clinical Diabetes and Endocrinology

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审稿时长

8 weeks

期刊介绍： Clinical Diabetes and Endocrinology is an open access journal publishing within the field of diabetes and endocrine disease. The journal aims to provide a widely available resource for people working within the field of diabetes and endocrinology, in order to improve the care of people affected by these conditions. The audience includes, but is not limited to, physicians, researchers, nurses, nutritionists, pharmacists, podiatrists, psychologists, epidemiologists, exercise physiologists and health care researchers. Research articles include patient-based research (clinical trials, clinical studies, and others), translational research (translation of basic science to clinical practice, translation of clinical practice to policy and others), as well as epidemiology and health care research. Clinical articles include case reports, case seminars, consensus statements, clinical practice guidelines and evidence-based medicine. Only articles considered to contribute new knowledge to the field will be considered for publication.