We aimed to evaluate the efficacy and safety profile of lobeglitazone compared with sitagliptin as an add-on to metformin in patients with type 2 diabetes as well as other components of metabolic syndrome. Patients inadequately controlled by metformin were randomly assigned to lobeglitazone (0.5 mg, n = 121) or sitagliptin (100 mg, n = 126) for 24 weeks. The mean changes in HbA1c of the lobeglitazone and sitagliptin groups were −0.79% and −0.86%, respectively; the between-group difference was 0.08% (95% confidence interval, −0.14% to 0.30%), showing non-inferiority. The proportion of patients having two or more factors of other metabolic syndrome components decreased to a greater extent in the lobeglitazone group than in the sitagliptin group (−11.9% vs. −4.8%; P <.0174). Favourable changes in the lipid metabolism were also observed with lobeglitazone, which had a similar safety profile to sitagliptin. Lobeglitazone was comparable with sitagliptin as an add-on to metformin in terms of efficacy and safety.
Bibliographical noteFunding Information:
Sin Gon Kim and Kyoung Jin Kim contributed equally to this study as first authors. This study was supported by the Chong Kun Dang Pharmaceutical Corp., Seoul, Republic of Korea. The sponsor participated in the study design, data collection and analysis of the data. The sponsor had no role in the writing of the manuscript or in the decision to submit the manuscript for publication.
© 2020 John Wiley & Sons Ltd
- clinical trial
- randomized trial
- type 2 diabetes
ASJC Scopus subject areas
- Internal Medicine
- Endocrinology, Diabetes and Metabolism