LG Chem confirms diabetes drug Zemidapa's efficacy in phase 3 trials

LG Chem Ltd. announced in a disclosure on Monday that it had confirmed superior efficacy in phase 3 clinical trials for the combined administration of Zemidapa, a new treatment for diabetes.

Zemidapa is a combination medication with two drug ingredients that contain LG Chem's proprietary type 2 diabetes drug Zemiglo (ingredient: gemigliptin) and another diabetes drug ingredient, dapagliflozin, in one tablet.

The company undertook a study on whether Zemidapa would be effective in type 2 diabetes patients whose blood sugar level was not properly controlled solely with metformin, the standard treatment for type 2 diabetes.

The researchers divided 470 patients who were administered metformin into three groups: a group who took both gemigliptin and dapagliflozin; one that took gemigliptin and a placebo; and another that took dapagliflozin and a placebo.

They then compared the degree of reduction in glycated hemoglobin (HbA1c) levels in each group. The larger the change in glycated hemoglobin, the greater the blood sugar control effect.

As a result, the change in HbA1c compared to baseline at 24 weeks was -1.34% in the group administered with both gemigliptin and dapagliflozin; -0.90% in the group administered with gemigliptin and placebo; and -0.78% in the group administered with dapagliflozin and placebo.

The company said that there was no significant difference in adverse reaction after administering the drugs to all groups.

"We expect to expand treatment options by allowing patients with type 2 diabetes who are unable to control their blood sugar level with metformin alone to be prescribed a combination of gemigliptin and dapagliflozin," an LG Chem official explained. 

"We plan to apply for a change of permission to reflect the clinical results within the first quarter of next year," he added.

Write to Jeong Min Nam at peux@hankyung.com