Abstract 165: Study of lobeglitazone for evaluation of safety and efficacy with active comparator pioglitazone in Indian T2DM patients: A randomized phase III trial (sensitize India)

Background: Lobeglitazone is a novel thiazolidinedione class of drug, acts by activating PPARγ in type 2 diabetes (T2DM). Evidence regarding its efficacy and safety is not available in Indian T2DM patients. Aims: To evaluate efficacy and safety of a novel thiazolidinedione, Lobeglitazone, in patients with T2DM uncontrolled on metformin. Methods: This was a 16-week randomized, double blind, double dummy, active controlled study which primarily evaluated change in HbA1c from baseline in Lobeglitazone (0.5 mg OD) compared to Pioglitazone (15 mg OD). Secondary endpoints were change in fasting (FBS) and post-prandial blood sugar (PBS). 12-week analysis results are presented here. Results: 317 patients were randomized to Lobeglitazone (N = 158) and Pioglitazone (N = 159) groups. HbA1c reduction from baseline to week 12 seen in Lobeglitazone group was 0.84% (baseline 8.6%) and in Pioglitazone group it was 0.74% (baseline 8.7%), p-value for non-inferiority being <0.0001. Secondary endpoints are mentioned in [Table 1]{Table 1} Reduction values mentioned are least square mean values. Conclusion: Lobeglitazone significantly improved the glycemic parameters and was well tolerated. Change in fasting insulin, HOMA-IR and HOMA-β in Lobeglitazone group was comparable to Pioglitazone. Lobeglitazone was found to be non-inferior to Pioglitazone in metformin uncontrolled T2DM patients.