e-Article
Efficacy and safety of fixed dose combination of Sitagliptin, metformin, and pioglitazone in type 2 Diabetes (IMPACT study): a randomized controlled trial
Document Type
article
Author
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
Source
Clinical Diabetes and Endocrinology, Vol 10, Iss 1, Pp 1-10 (2024)
Subject
Language
English
ISSN
2055-8260
Abstract
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.