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KMID : 1200020200440010067
Diabetes & Metabolism Journal
2020 Volume.44 No. 1 p.67 ~ p.77
Efficacy and Safety of Pioglitazone versus Glimepiride after Metformin and Alogliptin Combination Therapy: A Randomized, Open-Label, Multicenter, Parallel-Controlled Study
Kim Jeong-Mi

Kim Sang-Soo
Kim Jong-Ho
Kim Mi-Kyung
Kim Tae-Nyun
Lee Soon-Hee
Lee Chang-Won
Park Ja-Young
Kim Eun-Sook
Lee Kwang-Jae
Choi Young-Sik
Kim Duk-Kyu
Kim In-Joo
Abstract
Background: There is limited information regarding the optimal third-line therapy for managing type 2 diabetes mellitus (T2DM) that is inadequately controlled using dual combination therapy. This study assessed the efficacy and safety of pioglitazone or glimepiride when added to metformin plus alogliptin treatment for T2DM.

Methods: This multicenter, randomized, active-controlled trial (ClinicalTrials.gov: NCT02426294) recruited 135 Korean patients with T2DM that was inadequately controlled using metformin plus alogliptin. The patients were then randomized to also receive pioglitazone (15 mg/day) or glimepiride (2 mg/day) for a 26-week period, with dose titration was permitted based on the investigator's judgement.

Results: Glycosylated hemoglobin levels exhibited similar significant decreases in both groups during the treatment period (pioglitazone: ?0.81%, P<0.001; glimepiride: ?1.05%, P<0.001). However, the pioglitazone-treated group exhibited significantly higher high density lipoprotein cholesterol levels (P<0.001) and significantly lower homeostatic model assessment of insulin resistance values (P<0.001). Relative to pioglitazone, adding glimepiride to metformin plus alogliptin markedly increased the risk of hypoglycemia (pioglitazone: 1/69 cases [1.45%], glimepiride: 14/66 cases [21.21%]; P<0.001).

Conclusion: Among patients with T2DM inadequately controlled using metformin plus alogliptin, the addition of pioglitazone provided comparable glycemic control and various benefits (improvements in lipid profiles, insulin resistance, and hypoglycemia risk) relative to the addition of glimepiride.
KEYWORD
Dipeptidyl-peptidase IV inhibitors, Drug therapy, combination, Sulfonylurea compounds, Thiazolidinediones, Treatment failure
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