Glycaemic control with add-on thiazolidinedione or a sodium-glucose co-transporter-2 inhibitor in patients with type 2 diabetes after the failure of an oral triple antidiabetic regimen: A 24-week, randomized controlled trial.

Abstract

To evaluate the effectiveness and safety of adding either a sodium-glucose co-transporter-2 inhibitor (SGLT2i) or thiazolidinedione (TZD) in patients with type 2 diabetes (T2D) inadequately controlled with triple therapy. In this prospective, open-label, multicentre, 24-week clinical trial, we randomly assigned 119 patients with T2D who failed to achieve glycaemic control (7% < HbA1c ≤ 10%) with conventional triple oral antidiabetic agents (OADs; metformin, sulphonylurea and dipeptidyl peptide-4 [DPP-4] inhibitor) into two groups who received either an SGLT2i or TZD. The primary endpoint was mean change in HbA1c level between the two groups at 24 weeks. In total, 119 patients were enrolled in the SGLT2i (n = 60) and TZD (n = 59) groups. Mean age of the study subjects was 61.86 years, and the mean duration of T2D was 13.89 years. After 24 weeks, both groups showed significant reductions in HbA1c (from 7.94% ± 0.74% to 6.97% ± 0.84% in the SGLT2i group and from 8.00% ± 0.78% to 7.18% ± 0.98% in the TZD group), without a significant between-group difference (P = .235). A significant body mass index (BMI) reduction was noted in the SGLT2i group, whereas an increase in BMI was noted in the TZD group (-0.79 ± 1.37 vs. 0.92 ± 0.86 kg/m2 , P < .001). Other safety profiles were favourable in both groups. The current study shows that an SGLT2i or TZD could be a valid option as a fourth OAD for treatment of patients with T2D inadequately controlled with a triple combination of OADs.