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
{"title":"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。","authors":"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","doi":"10.1186/s40842-023-00161-6","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>Clinical Trials Registry of India, CTRI/2021/10/037461.</p>","PeriodicalId":56339,"journal":{"name":"Clinical Diabetes and Endocrinology","volume":"10 1","pages":"3"},"PeriodicalIF":0.0000,"publicationDate":"2024-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10858534/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of fixed dose combination of Sitagliptin, metformin, and pioglitazone in type 2 Diabetes (IMPACT study): a randomized controlled trial.\",\"authors\":\"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\",\"doi\":\"10.1186/s40842-023-00161-6\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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. 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Efficacy and safety of fixed dose combination of Sitagliptin, metformin, and pioglitazone in type 2 Diabetes (IMPACT study): a randomized controlled trial.
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.
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.
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