Diabetes, obesity & metabolism · 2025
Lobeglitazone improves glycaemic control as add-on therapy to empagliflozin plus metformin in patients with type 2 diabetes mellitus: A double-blind, randomised, placebo-controlled trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Seo Da Hea, Min Kyung Wan, Sohn Ho Sang, Kim Sang Yong, Jeong In-Kyung, Park Cheol-Young, Yoon Kun-Ho, Kim So Hun, Cha Bong-Soo
Аннотация
AIMS: This study aimed to evaluate the efficacy and safety of triple therapy with lobeglitazone 0.5 mg as an add-on treatment compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin and empagliflozin.
MATERIALS AND METHODS: In this Phase 3, multicentre, double-blind, randomised trial, patients with T2DM who had an insufficient response to metformin (≥1000 mg/day) and empagliflozin 10 mg/day (Study 1) or 25 mg/day (Study 2) were randomised to receive either lobeglitazone 0.5 mg/day, or placebo once daily for 24 weeks. Participants then entered an open-label extension phase for an additional 28 weeks, bringing the total treatment duration to 52 weeks. The primary endpoint was the change from baseline in glycated haemoglobin (HbA1c) at 24 weeks.
RESULTS: At 24 weeks, the mean change in HbA1c was significantly greater with lobeglitazone than with placebo, regardless of the background empagliflozin dose (-0.71%; 95% confidence interval, -0.88 to -0.55; p < 0.001 in Study 1 and -0.62%; -0.79 to -0.45; p < 0.001 in Study 2). A higher proportion of patients achieved HbA1c levels <7% with lobeglitazone compared to placebo (48.7% vs. 13.4% in Study 1, and 44.4% vs. 13.0% in Study 2; p < 0.001). Although the incidence of adverse events was numerically different between groups, no statistically significant differences were observed, indicating a generally comparable profile for the triple combination therapy with metformin, empagliflozin, and lobeglitazone.
CONCLUSIONS: Lobeglitazone as an add-on to empagliflozin and metformin significantly improved glycaemic control in patients with T2DM inadequately controlled on metformin and empagliflozin dual therapy. The treatment was well tolerated, with a low incidence of adverse events.
MATERIALS AND METHODS: In this Phase 3, multicentre, double-blind, randomised trial, patients with T2DM who had an insufficient response to metformin (≥1000 mg/day) and empagliflozin 10 mg/day (Study 1) or 25 mg/day (Study 2) were randomised to receive either lobeglitazone 0.5 mg/day, or placebo once daily for 24 weeks. Participants then entered an open-label extension phase for an additional 28 weeks, bringing the total treatment duration to 52 weeks. The primary endpoint was the change from baseline in glycated haemoglobin (HbA1c) at 24 weeks.
RESULTS: At 24 weeks, the mean change in HbA1c was significantly greater with lobeglitazone than with placebo, regardless of the background empagliflozin dose (-0.71%; 95% confidence interval, -0.88 to -0.55; p < 0.001 in Study 1 and -0.62%; -0.79 to -0.45; p < 0.001 in Study 2). A higher proportion of patients achieved HbA1c levels <7% with lobeglitazone compared to placebo (48.7% vs. 13.4% in Study 1, and 44.4% vs. 13.0% in Study 2; p < 0.001). Although the incidence of adverse events was numerically different between groups, no statistically significant differences were observed, indicating a generally comparable profile for the triple combination therapy with metformin, empagliflozin, and lobeglitazone.
CONCLUSIONS: Lobeglitazone as an add-on to empagliflozin and metformin significantly improved glycaemic control in patients with T2DM inadequately controlled on metformin and empagliflozin dual therapy. The treatment was well tolerated, with a low incidence of adverse events.