[Asia Economy Reporter Chunhee Lee] LG Chem's diabetes treatment drug 'Gemiglo' has proven its blood sugar-lowering efficacy in patients whose blood sugar is not adequately controlled.
LG Chem announced on the 7th that it will disclose the Phase 3 clinical trial results of Gemiglo as an additional triple combination therapy at the International Diabetes Federation (IDF) Congress. In this clinical trial, 315 diabetic patients who were taking the first-line Type 2 diabetes drug 'Metformin' along with the latest diabetes medication from the SGLT-2 inhibitor class, 'Dapagliflozin,' were given either Gemiglo or a placebo for 24 weeks, after which glycated hemoglobin (HbA1c) levels and other measures were compared.
The clinical results showed that at 24 weeks, the change in HbA1c from baseline was -0.86% in the Gemiglo group and -0.20% in the placebo group, demonstrating superior blood sugar reduction efficacy in the Gemiglo group compared to the placebo group. The incidence of adverse reactions, including hypoglycemia, showed no significant difference between the two groups.
Regarding the achievement rate of HbA1c levels reaching 7.0%, the Gemiglo group showed 60.56%, outperforming the placebo group (17.53%). For the target HbA1c level of 6.5%, the Gemiglo group also showed superior results at 22.02% compared to the placebo group (2.43%). Significant efficacy differences were also confirmed in fasting plasma glucose (FPG) changes compared to the placebo group.
LG Chem applied for marketing authorization from the Ministry of Food and Drug Safety last October for a new diabetes combination drug combining Gemiglo with dapagliflozin. The domestic product launch is expected in 2023.
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