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
Main Authors:	Aashish, Mondal, Arindam, Naskar, Siddiqi, Sheelu Shafiq, Bhosle, Deepak, Mallikarjuna, V J, Amol, Dange, Sanket, Sorate, Omkar, Gavali, Parth, Patel, Dhruvi, Hasnani, Durga, Prasad, Pradeep, Dalwadi, Suresh, Kumar, Vaishali, Pathak, Mayura, Chaudhari, Indraneel, Basu, Jayashri, Shembalkar, Arif, Fariooqui, Raghavendra, S K, Deepak, Varade, Ravindra, Thakkar, Shaishav, Bhanushali, Vijay, Gaikwad, Khan, Kamran, Mahajani, V V, Sharma, A D, Mayabhate, Mayur, Pawar, R R, Aiwale, A S, Vinayaka, Shahavi
Format:	Journal Article
Language:	English
Published:	England BioMed Central Ltd 10-02-2024 BioMed Central BMC
Subjects:	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 India Sitagliptin IMPACT study Metformin Type 2 diabetes mellitus Triple therapy Pioglitazone
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Summary:	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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	2055-8260 2055-8260
DOI:	10.1186/s40842-023-00161-6