Add-On Lobeglitazone Boosts Glycemic Control in T2D
Patients with type 2 diabetes (T2D) who responded inadequately to sitagliptin plus metformin experienced improvements in glycemic control and insulin sensitivity after lobeglitazone was added to their regimen.
METHODOLOGY:
Metformin and DPP-4 inhibitors such as sitagliptin are widely used for glycemic control in patients with T2D; however, the choice of which agent to add when these therapies fail to achieve target blood glucose levels remains unclear.
Researchers in Korea conducted a phase 3 trial from April 2018 to December 2021 to evaluate the efficacy and safety of adding lobeglitazone to the dual therapy regimen of metformin (≥ 1000 mg/d) and sitagliptin (100 mg/d).
The study included 231 patients with T2D (mean age, 58.65 years; 56.52% men) whose A1c ranged from 7.0% to 10.0% despite receiving the dual therapy.
After a 2-week run-in period, patients were randomly assigned to receive either a 0.5 mg/d dose of lobeglitazone (n = 116) or placebo (n = 115) alongside metformin and sitagliptin for 24 weeks, followed by a 28-week open-label phase in which all patients received lobeglitazone.
The primary endpoint was the change from baseline in mean A1c at 24 weeks. Secondary endpoints included changes in additional glycemic and lipid parameters and safety outcomes.
TAKEAWAY:
At week 24, mean A1c levels were 1.03% lower in patients who received lobeglitazone vs placebo (95% CI, -1.23% to -0.82%), with the reduction being maintained until 52 weeks; those who switched from placebo to lobeglitazone at week 24 also saw a reduction in A1c levels by week 52.
Additionally, at week 24, a higher proportion of patients receiving lobeglitazone vs placebo achieved A1c levels < 6.5% (27.14% vs 0.87%) and < 7% (53.04% vs 13.04%; both P < .0001).
The addition of lobeglitazone to dual therapy significantly improved insulin sensitivity markers compared with placebo at week 24, with effects sustained till week 52; additionally, administration of lobeglitazone reduced low-density lipoprotein cholesterol levels.
The incidence of adverse events was not significantly different between the two groups; the incidence of edema and weight gain in some patients receiving lobeglitazone aligned with the known effects of thiazolidinediones.
IN PRACTICE:
'The observed improvements in various glucose-related metabolic factors and lipid metabolism indicators with lobeglitazone coadministration may provide valuable evidence for long-term blood glucose management and cardiovascular risk reduction,' the authors of the study wrote.
SOURCE:
This study was led by Eun-Gyoung Hong, MD, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, South Korea. It was published online in Diabetes, Obesity and Metabolism.
LIMITATIONS:
A longer follow-up might be needed to fully evaluate the sustained effects of the study outcomes and potential side effects.
DISCLOSURES:
This study received funding from Chong Kun Dang Pharmaceutical Company. The authors declared having no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
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