Efficacy and safety of lobeglitazone added to metformin and sitagliptin combination therapy in patients with type 2 diabetes: A 52-week, multicentre, randomized, placebo-controlled, phase III clinical trial.

ABSTRACT:

Aims

To evaluate the efficacy and safety of adding lobeglitazone to a triple therapy regimen in Korean patients with type 2 diabetes whose blood glucose levels were inadequately controlled despite dual therapy with metformin and sitagliptin.

Materials and methods

This randomised, double-blind, placebo-controlled, phase 3 study involved 231 Korean patients with type 2 diabetes whose HbA1c levels ranged from 7.0% to 10.0% despite treatment with metformin (≥1000 mg/day) and sitagliptin (100 mg/day). Participants received lobeglitazone (0.5 mg/day) or placebo for 24 weeks, followed by a 28-week open-label phase in which all patients received lobeglitazone. The primary endpoint was the change in glycated haemoglobin (HbA1c) at 24 weeks; secondary endpoints included changes in fas

SUBMITTER: Hong EG 

PROVIDER: S-EPMC12409244 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature