Low-dose lobeglitazone effective against type 2 diabetes, study finds
South Korea: The addition of low-dose lobeglitazone to the combination of metformin and DPP4 inhibitor versus standard-dose lobeglitazone led to non-inferior glucose-lowering outcomes and fewer adverse events, researchers state in a recent study.
The findings of the REFIND study, published in the journal Diabetes, Obesity and Metabolism, therefore suggest that low-dose lobeglitazone might be an option for individualized strategy in type 2 diabetes (T2DM) patients.
Soree Ryang, Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea, and colleagues conducted a double-blind, randomized controlled trial to compare the safety and efficacy of low-dose lobeglitazone (0.25 mg/day) or standard-dose lobeglitazone (0.5 mg/day) addition to T2DM patients with inadequate glucose control on metformin and dipeptidyl peptidase (DPP4) inhibitor therapy.
For this purpose, the researchers included patients with T2DM insufficiently controlled by metformin and DPP4 inhibitor combination therapy in phase 4, a multicentre, double-blind, randomized controlled, non-inferiority trial. They were randomized to receive either low-dose or standard-dose lobeglitazone.
The primary endpoint of the study was non-inferiority of low-dose lobeglitazone in terms of glycaemic control, expressed as the difference in mean glycated hemoglobin levels at week 24 relative to baseline values compared with standard-dose lobeglitazone, using 0.5% non-inferiority margin.
The study led to the following findings:
- At week 24, the mean glycated hemoglobin levels were 6.87 ± 0.54% and 6.68 ± 0.46% in low-dose and standard-dose lobeglitazone groups, respectively.
- The between-group difference was 0.18%, showing non-inferiority of the low-dose lobeglitazone.
- Mean body weight changes were significantly greater in the standard-dose group (1.36 ± 2.23 kg) than in the low-dose group (0.50 ± 1.85 kg) at week 24.
- The changes in HOMA-IR, lipid profile and liver enzyme levels showed no significant difference between the groups.
- Overall treatment-emergent adverse events (including weight gain, edema, and hypoglycemia) occurred more frequently in the standard-dose group.
"By adding this dosage, we will be able to expand the opportunity to provide precision medicine to patients with T2DM," the researchers wrote in their conclusion.
Reference:
Ryang S, Kim SS, Bae JC, Han JM, Kwon SK, Kim YI, Nam-Goong IS, Kim ES, Kim MK, Lee CW, Yoo S, Koh G, Kwon MJ, Park JH, Kim IJ. A double-blind, Randomized controlled trial on glucose-lowering EFfects and safety of adding 0.25 or 0.5 mg lobeglitazone in type 2 diabetes patients with INadequate control on metformin and dipeptidyl peptidase-4 inhibitor therapy: REFIND study. Diabetes Obes Metab. 2022 Sep;24(9):1800-1809. doi: 10.1111/dom.14766. Epub 2022 Jun 9. PMID: 35581902.
