TY - JOUR
T1 - Effect of saroglitazar 2 mg and 4 mg on glycemic control, lipid profile and cardiovascular disease risk in patients with type 2 diabetes mellitus
T2 - A 56-week, randomized, double blind, phase 3 study (PRESS XII study)
AU - Krishnappa, Manjunath
AU - Patil, Kishor
AU - Parmar, Krupi
AU - Trivedi, Purav
AU - Mody, Nirali
AU - Shah, Chintan
AU - Faldu, Khushboo
AU - Maroo, Sanjay
AU - Desai, Piyush
AU - Fatania, Kamlesh
AU - Murthy, Satyanarayan
AU - Balamurugan, R.
AU - Agarwal, Manish
AU - Singh, K. P.
AU - Kalra, G. S.
AU - Khandelwal, Vipul
AU - Singwala, Ashish
AU - Thacker, Hemant
AU - Tulle, Rahul
AU - Rao, Harish
AU - Kumbla, Mukund
AU - Singh, Parminder
AU - Khatri, Ashok
AU - Agrawal, Sumit
AU - Sarkar, R. N.
AU - Agarwal, Dinesh
AU - Bhatia, Girish
AU - Agarwal, R. P.
AU - Kumar, Surender
AU - Vamsi Krishna, P. R.
AU - Ajmani, Ajay Kumar
AU - Asalkar, Amit
AU - Basu, Indraneel
AU - Chatterjee, Sudip
AU - Pavithran, Vinod Kumar
AU - Das, Rupam
AU - Dharmadhikari, Aniruddha
AU - Vardhan, Vikram
AU - Madusudhan Babu, M.
AU - Sengupta, Nilanjan
AU - Abkari, Srirang
AU - Harikrishna, R.
AU - Chovatia, Rashmi
AU - Parmar, Deven
N1 - Funding Information:
This trial was sponsored and funded by Cadila Healthcare Ltd., Ahmedabad, India.
Publisher Copyright:
© 2020 The Author(s).
PY - 2020/6/19
Y1 - 2020/6/19
N2 - Background: The potential for PPAR agonists to positively affect risk of cardiovascular disease in patients with type 2 diabetes (T2DM) is of persistent attention. The PRESS XII study primarily aimed to evaluate the efficacy and safety of saroglitazar (2 mg and 4 mg) as compared to pioglitazone 30 mg on glycemic control in patients with type 2 diabetes mellitus. Methods: In this randomized double-blind study, patients with T2DM [glycosylated hemoglobin (HbA1c) ≥ 7.5%] were enrolled from 39 sites in India. Patients received once-daily doses of either saroglitazar or pioglitazone (1:1:1 allocation ratio) for a total of 24 weeks. Patients were continued in a double blind extension period for an additional 32 weeks. Efficacy evaluations of glycemic parameters [HbA1c (Primary endpoint at week 24), FPG and PPG] and other lipid parameters (TG, LDL-C, VLDL-C, HDL-C, TC, Non HDL-C, Apo A1 and Apo B) were conducted at week 12, 24 and 56 and compared to the baseline levels. The efficacy analyses were performed by using paired t-test and ANCOVA model. Results: A total of 1155 patients were enrolled in this study. The baseline characteristics were similar between the three treatment groups. The within group mean (± SD) change in HbA1c (%) from baseline of the saroglitazar (2 mg and 4 mg) and pioglitazone treatment groups at week 24 were: - 1.38 ± 1.99 for saroglitazar 2 mg; - 1.47 ± 1.92 for saroglitazar 4 mg and - 1.41 ± 1.86 for pioglitazone, respectively. Statistically significant reduction from baseline in HbA1c was observed in each treatment group at week 24 with p-value < 0.016. There was a significant reduction in TG, LDL-C, VLDL-C, TC and Non HDL-C with a significant increase in HDL-C from baseline levels (< 0.016). Most of the AE's were 'mild' to 'moderate' in severity and were resolved by the completion of the study. Conclusions: Saroglitazar effectively improved glycemic control and lipid parameters over 56 weeks in patients of T2DM receiving background metformin therapy and has a promising potential to reduce the cardiovascular risk in T2DM patients.
AB - Background: The potential for PPAR agonists to positively affect risk of cardiovascular disease in patients with type 2 diabetes (T2DM) is of persistent attention. The PRESS XII study primarily aimed to evaluate the efficacy and safety of saroglitazar (2 mg and 4 mg) as compared to pioglitazone 30 mg on glycemic control in patients with type 2 diabetes mellitus. Methods: In this randomized double-blind study, patients with T2DM [glycosylated hemoglobin (HbA1c) ≥ 7.5%] were enrolled from 39 sites in India. Patients received once-daily doses of either saroglitazar or pioglitazone (1:1:1 allocation ratio) for a total of 24 weeks. Patients were continued in a double blind extension period for an additional 32 weeks. Efficacy evaluations of glycemic parameters [HbA1c (Primary endpoint at week 24), FPG and PPG] and other lipid parameters (TG, LDL-C, VLDL-C, HDL-C, TC, Non HDL-C, Apo A1 and Apo B) were conducted at week 12, 24 and 56 and compared to the baseline levels. The efficacy analyses were performed by using paired t-test and ANCOVA model. Results: A total of 1155 patients were enrolled in this study. The baseline characteristics were similar between the three treatment groups. The within group mean (± SD) change in HbA1c (%) from baseline of the saroglitazar (2 mg and 4 mg) and pioglitazone treatment groups at week 24 were: - 1.38 ± 1.99 for saroglitazar 2 mg; - 1.47 ± 1.92 for saroglitazar 4 mg and - 1.41 ± 1.86 for pioglitazone, respectively. Statistically significant reduction from baseline in HbA1c was observed in each treatment group at week 24 with p-value < 0.016. There was a significant reduction in TG, LDL-C, VLDL-C, TC and Non HDL-C with a significant increase in HDL-C from baseline levels (< 0.016). Most of the AE's were 'mild' to 'moderate' in severity and were resolved by the completion of the study. Conclusions: Saroglitazar effectively improved glycemic control and lipid parameters over 56 weeks in patients of T2DM receiving background metformin therapy and has a promising potential to reduce the cardiovascular risk in T2DM patients.
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U2 - 10.1186/s12933-020-01073-w
DO - 10.1186/s12933-020-01073-w
M3 - Article
C2 - 32560724
AN - SCOPUS:85086753586
SN - 1475-2840
VL - 19
JO - Cardiovascular Diabetology
JF - Cardiovascular Diabetology
IS - 1
M1 - 93
ER -
