Background: Lobeglitazone, a novel TZD was recently approved in India for T2DM, has limited real-world data. This study assessed the effectiveness and safety of Lobeglitazone 0.5 mg once daily in real-world settings.
Methods: Data was captured from the medical records of patients after obtaining independent ethics committee approval from 16 different sites across India. The primary outcome was % change in HbA1c at week 12. Secondary outcomes were changes in the fasting blood sugar (FBS), post-prandial blood sugar (PPBS), lipid, liver and renal parameters and treatment emergent adverse effects at week 12. Statistical analysis was performed using paired t-test.
Results: Records of N=544 patients (60.4% males and 39.6% females), with a mean age of 52.6 ± 11.8 years were analysed. Baseline mean HbA1c reduced from 8.82 ± 1.57% to 7.62 ± 1.3% (mean reduction: 1.2%, p-value<0.0001; Figure 1). Proportion of patients achieving HbA1c <7% was 31.6% at week12. Changes in glycemic, lipid, liver and renal parameters are depicted in Table 1. There were no significant changes in body weight (p=0.17). Increase and decrease in the body weight and pedal oedema were reported in 0.92%, 2.39% and 0.37% individuals respectively. There were no reports of hypoglycaemia or any cardiac events in the enrolled patients.
Conclusion: Lobeglitazone significantly improved glycemic parameters, Sr. creatinine, Sr. bilirubin and total cholesterol levels and was well tolerated in Indian Type 2 diabetes patients in the real world setting.
Figure 1: Graphical Representation of change in HbA1c% at week12Table 1: Changes in glycemic, lipid, liver and renal parameters from baseline to week12
H.V. Barkate: Employee; Glenmark Pharmaceuticals. K.R. Chitnis: None. A.U. Petare: Employee; Glenmark Pharmaceuticals. S.Y. Choudhari: Employee; Glenmark Pharmaceuticals, Sun Pharmaceutical Industries Ltd. S. Bhushan: None. S. Patil: Employee; Glenmark Pharmaceuticals.
