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

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Authors: Kim, Kyuho ; Ko, Seung-Hyun ; Yun, Jae-Seung ; Lee, Kwan-Woo ; Kim, Eun Sook ; Jeong, In-Kyung ; Kim, Jae Hyeon ; Kim, Sang Yong ; Won, Kyu Chang ; Kim, Mikyung ; Cha, Bong-Soo ; Kim, Sungrae ; Choi, Sung Hee ; Rhee, Eun-Jung ; Kim, Sin Gon ; Kim, Bo Hyun ; Park, Kang Seo ; Ju, Young-Cheol ; Heo, Tae-Won ; Ahn, Yu-Bae

MeSH: Aged ; Benzhydryl Compounds* / administration & dosage ; Benzhydryl Compounds* / adverse effects ; Benzhydryl Compounds* / therapeutic use ; Blood Glucose ; Diabetes Mellitus, Type 2* / blood ; Diabetes Mellitus, Type 2* / drug therapy ; Drug Therapy, Combination ; Female ; Glucosides* / administration & dosage ; Glucosides* / adverse effects ; Glucosides* / therapeutic use ; Glycated Hemoglobin / analysis ; Glycated Hemoglobin / metabolism ; Humans ; Hypoglycemic Agents* / administration & dosage ; Hypoglycemic Agents* / adverse effects ; Hypoglycemic Agents* / therapeutic use ; Male ; Metformin* / administration & dosage ; Metformin* / adverse effects ; Metformin* / therapeutic use ; Middle Aged ; Pioglitazone* / administration & dosage ; Pioglitazone* / adverse effects ; Pioglitazone* / therapeutic use ; Piperidines* / administration & dosage ; Piperidines* / adverse effects ; Piperidines* / therapeutic use ; Treatment Outcome ; Uracil* / administration & dosage ; Uracil* / adverse effects ; Uracil* / analogs & derivatives ; Uracil* / therapeutic use

Keywords: Dipeptidyl-peptidase IV inhibitors ; Drug therapy ; Combination ; Sodium-glucose transporter 2 inhibitors ; Thiazolidinediones

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 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.