Dong-A ST "New Diabetes Drug Shows Blood Sugar Lowering Effect in US Phase 1b Trial"

Announcement of Clinical Phase 1b Results at the American Diabetes Association (ADA 2021)

Donga Socio R&D Center (Photo by Donga ST)

[Asia Economy Reporter Kim Ji-hee] Dong-A ST's new diabetes treatment drug ‘DA-1241’ has demonstrated excellent blood glucose-lowering effects in a Phase 1b clinical trial.

Dong-A ST announced on the 28th that it presented the results of the US Phase 1b clinical trial of the type 2 diabetes treatment drug ‘DA-1241’ at the American Diabetes Association (ADA 2021), held online from the 25th to the 29th of this month (US local time).

DA-1241 is a first-in-class innovative drug with a GPR119 agonist mechanism. GPR119 is a receptor present in pancreatic beta cells that, when activated, increases insulin secretion depending on the amount of glucose or lipid metabolites. DA-1241 activates this receptor to improve postprandial blood glucose without the risk of hypoglycemia.

The US Phase 1b trial was conducted as a repeated dosing and dose-escalation study in healthy subjects and patients with type 2 diabetes. Diabetic patients took metformin along with placebo, sitagliptin, or DA-1241 at doses of 25, 50, or 100 mg once daily for 8 weeks. The clinical trial, conducted as a controlled, double-blind, randomized study, confirmed the superior clinical significance of DA-1241.

In the measurement of the area under the curve for blood glucose increase to evaluate the postprandial blood glucose reduction effect due to GPR119 activation, DA-1241 100 mg (-13.8%) showed a blood glucose improvement effect similar to sitagliptin 100 mg (-9.0%) compared to before administration. It also showed a significantly superior blood glucose improvement effect compared to placebo (+10.5%).

Indicators of blood glucose variability through fasting blood glucose and continuous glucose monitoring showed levels similar to sitagliptin. Notably, DA-1241 was found to increase GLP-1 secretion upon administration, confirming the activation of the GPR119 receptor by DA-1241 in the body. Sitagliptin, on the other hand, showed a decrease in GLP-1 secretion over time after administration.

No clinically significant adverse effects were observed, and DA-1241 100 mg (-2.2%, -1.57 kg) showed a relatively higher weight reduction effect compared to placebo (-0.3%) and sitagliptin (-0.3%).

A Dong-A ST official stated, “While many pharmaceutical companies have previously attempted to develop GPR119 agonist class treatments but failed to prove clinical efficacy, Dong-A ST has significant meaning in deriving a candidate substance with improved efficacy in nonclinical studies and confirming its characteristics in exploratory clinical trials,” adding, “Based on the successful verification of the drug’s action in diabetic patients, we plan to apply for a Phase 2 IND within this year.”

This content was produced with the assistance of AI translation services.