Efficacy and safety of pioglitazone versus dapagliflozin as an add-on to metformin and alogliptin combination therapy: the EPIDOTE study.

ABSTRACT: We investigated the efficacy and safety of pioglitazone compared to dapagliflozin when added to metformin plus alogliptin for patients with type 2 diabetes. The patients (n = 133) were randomized to receive pioglitazone (n = 65) or dapagliflozin (n = 68) in addition to metformin and alogliptin therapy for 26 weeks. The primary endpoint was a change in HbA1c. The non-inferiority margin for HbA1c reduction was 0.4%. The adjusted mean change of HbA1c at week 26 was - 0.75% with pioglitazone and - 0.88% with dapagliflozin (mean difference: 0.12% [95% CI - 0.09 to 0.34]). The adjusted mean change of HOMA-IR at week 26 was - 1.55 with pioglitazone and - 1.96 with dapagliflozin (mean difference: 0.41 [95% CI - 0.01 to 0.83]). Lipid profiles were similar between the groups. The proportion of patie

SUBMITTER: Kim K 

PROVIDER: S-EPMC12789535 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature