| Title: |
Efficacy and safety of pioglitazone versus dapagliflozin as an add-on to metformin and alogliptin combination therapy: the EPIDOTE study |
| Authors: |
Kim, K; Ko, SH; Yun, JS; Lee, KW; Kim, ES; Jeong, IK; Kim, JH; Kim, SY; Won, KC; Kim, M; Cha, BS; Kim, S; Choi, SH; Rhee, EJ; Kim, SG; Kim, BH; Park, KS; Ju, YC; Heo, TW; Ahn, YB |
| Contributors: |
101983; Lee, KW |
| Publication Year: |
2026 |
| Subject Terms: |
Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus; Type 2; Drug Therapy; Combination; Female; Glucosides; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Male; Metformin; Middle Aged; Pioglitazone; Piperidines; Treatment Outcome; Uracil; Dipeptidyl-peptidase IV inhibitors; Sodium-glucose transporter 2 inhibitors; Thiazolidinediones |
| Description: |
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 patients achieving HbA1c < 6.5% was similar between groups. Pioglitazone added to metformin and alogliptin significantly improved glycemic control in patients with type 2 diabetes, and was non-inferior to dapagliflozin. This study suggests that pioglitazone could be an effective and safe option for patients with inadequate glycemic control on metformin and DPP4i. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
J020452322; http://repository.ajou.ac.kr/handle/201003/34928; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12789535 |
| DOI: |
10.1038/s41598-025-30882-w |
| Availability: |
http://repository.ajou.ac.kr/handle/201003/34928; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12789535; https://doi.org/10.1038/s41598-025-30882-w |
| Accession Number: |
edsbas.4E32012C |
| Database: |
BASE |