Efficacy and safety of fixed dose combination of Sitagliptin, metformin, and pioglitazone in type 2 Diabetes (IMPACT study): a randomized controlled trial
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 metformi...
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| Published in: | Clinical diabetes and endocrinology Vol. 10; no. 1; p. 3 |
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| Abstract | 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).
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.
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.
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.
Clinical Trials Registry of India, CTRI/2021/10/037461. |
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| AbstractList | 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).
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.
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.
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.
Clinical Trials Registry of India, CTRI/2021/10/037461. BACKGROUNDDue 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).METHODSIn 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.RESULTSAmong 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.CONCLUSIONThe 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 REGISTRATIONClinical Trials Registry of India, CTRI/2021/10/037461. BackgroundDue 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).MethodsIn 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.ResultsAmong 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.ConclusionThe 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 registrationClinical Trials Registry of India, CTRI/2021/10/037461. 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. Background Due to the progressive decline in [beta]-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 [greater than or equal to]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. Keywords: Type 2 diabetes mellitus, IMPACT study, Pioglitazone, Metformin, Sitagliptin, Triple therapy 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. Due to the progressive decline in [beta]-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). 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 [greater than or equal to]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. 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. 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. |
| ArticleNumber | 3 |
| Audience | Academic |
| Author | Siddiqi, Sheelu Shafiq Shaishav, Bhanushali Bhosle, Deepak Amol, Dange Raghavendra, S K Pradeep, Dalwadi Vinayaka, Shahavi Indraneel, Basu Sanket, Sorate Sharma, A D Deepak, Varade Arindam, Naskar Omkar, Gavali Vijay, Gaikwad Khan, Kamran Jayashri, Shembalkar Aiwale, A S Mallikarjuna, V J Durga, Prasad Mayura, Chaudhari Mahajani, V V Vaishali, Pathak Aashish, Mondal Suresh, Kumar Pawar, R R Mayabhate, Mayur Dhruvi, Hasnani Ravindra, Thakkar Arif, Fariooqui Parth, Patel |
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| Keywords | Sitagliptin IMPACT study Metformin Type 2 diabetes mellitus Triple therapy Pioglitazone |
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| PublicationPlace_xml | – name: England – name: London |
| PublicationTitle | Clinical diabetes and endocrinology |
| PublicationTitleAlternate | Clin Diabetes Endocrinol |
| PublicationYear | 2024 |
| Publisher | BioMed Central Ltd BioMed Central BMC |
| Publisher_xml | – name: BioMed Central Ltd – name: BioMed Central – name: BMC |
| References | M Jameshorani (161_CR7) 2017; 5 161_CR2 C Melikian (161_CR18) 2002; 24 G Derosa (161_CR8) 2010; 59 BM Shields (161_CR27) 2023; 29 E Bosi (161_CR22) 2011; 13 M Hanefeld (161_CR26) 2001; 121 V Fonseca (161_CR11) 2013; 27 U Galicia-Garcia (161_CR4) 2020; 21 A Ceriello (161_CR14) 2005; 28 S Lim (161_CR21) 2020; 8 RC Turner (161_CR5) 1999; 281 BJ Goldstein (161_CR17) 2002; 90 DS Arya (161_CR24) 2019; 67 RA DeFronzo (161_CR20) 2012; 97 CJ Bailey (161_CR23) 2010; 19 RA DeFronzo (161_CR3) 2013; 36 DQ Holland (161_CR19) 2014; 7 YK Gupta (161_CR25) 2016; 48 V Hutchins (161_CR28) 2011; 27 American Diabetes Association (161_CR6) 2012; 35 S Chawla (161_CR9) 2013; 4 B Cariou (161_CR12) 2012; 23 S Del Prato (161_CR15) 2018; 20 I Raz (161_CR10) 2008; 24 S Kalra (161_CR1) 2020; 9 AJ Garber (161_CR13) 2018; 24 J Bae (161_CR16) 2019; 10 |
| References_xml | – volume: 281 start-page: 2005 year: 1999 ident: 161_CR5 publication-title: JAMA. doi: 10.1001/jama.281.21.2005 contributor: fullname: RC Turner – volume: 5 start-page: 955 issue: 7 year: 2017 ident: 161_CR7 publication-title: Open Access Maced J Med Sci. doi: 10.3889/oamjms.2017.193 contributor: fullname: M Jameshorani – volume: 23 start-page: 205 year: 2012 ident: 161_CR12 publication-title: Trends Endocrinol Metab. doi: 10.1016/j.tem.2012.03.001 contributor: fullname: B Cariou – volume: 13 start-page: 1088 issue: 12 year: 2011 ident: 161_CR22 publication-title: Diabetes Obes Metab. doi: 10.1111/j.1463-1326.2011.01463.x contributor: fullname: E Bosi – volume: 48 start-page: 347 year: 2016 ident: 161_CR25 publication-title: Indian J Pharmacol. doi: 10.4103/0253-7613.186200 contributor: fullname: YK Gupta – volume: 24 start-page: 460 issue: 3 year: 2002 ident: 161_CR18 publication-title: Clin Ther. doi: 10.1016/S0149-2918(02)85047-0 contributor: fullname: C Melikian – volume: 67 start-page: 58 issue: 12 year: 2019 ident: 161_CR24 publication-title: J Assoc Physicians India. contributor: fullname: DS Arya – volume: 19 start-page: 1017 issue: 8 year: 2010 ident: 161_CR23 publication-title: Expert Opin Investig Drugs. doi: 10.1517/13543784.2010.505235 contributor: fullname: CJ Bailey – volume: 21 start-page: 6275 issue: 17 year: 2020 ident: 161_CR4 publication-title: Int J Mol Sci. doi: 10.3390/ijms21176275 contributor: fullname: U Galicia-Garcia – volume: 4 start-page: 27 issue: 1 year: 2013 ident: 161_CR9 publication-title: J Pharmacol Pharmacother. doi: 10.4103/0976-500X.107656 contributor: fullname: S Chawla – volume: 97 start-page: 1615 issue: 5 year: 2012 ident: 161_CR20 publication-title: J Clin Endocrinol Metab. doi: 10.1210/jc.2011-2243 contributor: fullname: RA DeFronzo – volume: 35 start-page: S11 issue: 1 year: 2012 ident: 161_CR6 publication-title: Diabetes Care. contributor: fullname: American Diabetes Association – volume: 27 start-page: 1157 issue: 6 year: 2011 ident: 161_CR28 publication-title: Curr Med Res Opin. doi: 10.1185/03007995.2011.570745 contributor: fullname: V Hutchins – volume: 90 start-page: 3G issue: 5A year: 2002 ident: 161_CR17 publication-title: Am J Cardiol. doi: 10.1016/S0002-9149(02)02553-5 contributor: fullname: BJ Goldstein – volume: 9 start-page: 5450 issue: 11 year: 2020 ident: 161_CR1 publication-title: J Family Med Prim Care. doi: 10.4103/jfmpc.jfmpc_843_20 contributor: fullname: S Kalra – volume: 8 start-page: e000807 year: 2020 ident: 161_CR21 publication-title: BMJ Open Diabetes Res Care. doi: 10.1136/bmjdrc-2019-000807 contributor: fullname: S Lim – volume: 24 start-page: 537 issue: 2 year: 2008 ident: 161_CR10 publication-title: Curr Med Res Opin. doi: 10.1185/030079908X260925 contributor: fullname: I Raz – volume: 24 start-page: 91 issue: 1 year: 2018 ident: 161_CR13 publication-title: Endocr Pract. doi: 10.4158/CS-2017-0153 contributor: fullname: AJ Garber – volume: 27 start-page: 177 issue: 2 year: 2013 ident: 161_CR11 publication-title: J Diabetes Complicat. doi: 10.1016/j.jdiacomp.2012.09.007 contributor: fullname: V Fonseca – volume: 36 start-page: S127 issue: 2 year: 2013 ident: 161_CR3 publication-title: Diabetes Care. doi: 10.2337/dcS13-2011 contributor: fullname: RA DeFronzo – volume: 29 start-page: 376 year: 2023 ident: 161_CR27 publication-title: Nat Med. doi: 10.1038/s41591-022-02120-7 contributor: fullname: BM Shields – ident: 161_CR2 – volume: 7 start-page: 277 year: 2014 ident: 161_CR19 publication-title: Diabetes Metab Syndr Obes. contributor: fullname: DQ Holland – volume: 59 start-page: 887 year: 2010 ident: 161_CR8 publication-title: Metabo Clin Exp. doi: 10.1016/j.metabol.2009.10.007 contributor: fullname: G Derosa – volume: 121 start-page: 27 year: 2001 ident: 161_CR26 publication-title: Int J Clin Pract Suppl. contributor: fullname: M Hanefeld – volume: 10 start-page: 149 issue: 1 year: 2019 ident: 161_CR16 publication-title: Diabetes Ther. doi: 10.1007/s13300-018-0541-y contributor: fullname: J Bae – volume: 28 start-page: 266 issue: 2 year: 2005 ident: 161_CR14 publication-title: Diabetes Care. doi: 10.2337/diacare.28.2.266 contributor: fullname: A Ceriello – volume: 20 start-page: 786 issue: 4 year: 2018 ident: 161_CR15 publication-title: Diabetes Obes Metab. doi: 10.1111/dom.13169 contributor: fullname: S Del Prato |
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| Snippet | 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... Abstract Background Due to the progressive decline in β-cell function, it is often necessary to utilize multiple agents with complementary mechanisms of action... Background Due to the progressive decline in [beta]-cell function, it is often necessary to utilize multiple agents with complementary mechanisms of action to... Due to the progressive decline in [beta]-cell function, it is often necessary to utilize multiple agents with complementary mechanisms of action to address... BackgroundDue to the progressive decline in β-cell function, it is often necessary to utilize multiple agents with complementary mechanisms of action to... BACKGROUNDDue to the progressive decline in β-cell function, it is often necessary to utilize multiple agents with complementary mechanisms of action to... Abstract Background Due to the progressive decline in β-cell function, it is often necessary to utilize multiple agents with complementary mechanisms of action... |
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| SubjectTerms | Antidiabetics Body weight Dextrose Diabetes Diabetes therapy Drug dosages Drug therapy, Combination Glucagon Glucose Glycosylated hemoglobin Hematology IMPACT study Insulin resistance Laboratories Medical research Medicine, Experimental Metformin Pioglitazone Sitagliptin Triple therapy Type 2 diabetes Type 2 diabetes mellitus |
| Title | Efficacy and safety of fixed dose combination of Sitagliptin, metformin, and pioglitazone in type 2 Diabetes (IMPACT study): a randomized controlled trial |
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