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Dong-A ST unveils clinical trial results for its diabetes treatment

Lee Han-soo  Published 2018.11.28  13:12  Updated 2018.11.28 13:12

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Dong-A ST has released the results of EVERGREEN, a clinical trial for Suganon (Ingredient: evogliptin), a dipeptidyl peptidase 4 (DPP-4) inhibitor.

The drug’s advantage is that patients can take it regardless of meals. Also, the small size of the tablets compared to other drugs makes it highly convenient for patients with chronic diseases and compliance. Patients with renal impairment can also take the medication without adjusting the dose.

The purpose of the study was to compare the efficacy, safety and blood glucose variability of evogliptin and linagliptin in Korean type 2 diabetic patients who have not experienced diabetes medication. The 207 patients who took part in the study were 20 years or older with type 2 diabetes mellitus and hemoglobin A1c (HbA1c) of 7.0 to 10.0 percent, and had not taken any oral hypoglycemic agents.

The study ran for a minimum of eight weeks, and the company divided the patients into two groups -- evogliptin and linagliptin – at 19 medical institutions from September 2016 to May 2018.

The primary efficacy results of the clinical trials showed that after 12 weeks, the levels of glycated hemoglobin of the evogliptin and linagliptin groups were significantly reduced by 0.85 and 0.75 percent, respectively, which proved non-inferiority between the two treatments.

In the secondary efficacy evaluation, evogliptin and linagliptin showed a response rate of 68.0 and 67.3 percent for achieving a glycated hemoglobin level of less than 7.0 percent, while showing 44.0 and 36.5 percent for a glycated hemoglobin level of less than 6.5 percent

Safety assessment results showed that both drugs had no serious adverse events.

Unlike evogliptin, however, one case of symptomatic hypoglycemia occurred in linagliptin, while three patients had to go through a metformin remission as they did not reach optimal blood glucose levels. There was no statistically significant difference between the two groups, though.

After 12 weeks of treatment, evogliptin and linagliptin reduced the mean amplitude of glycemic excursions (MAGE) to 24.6 mg/dL and 16.7 mg/dL.

It is known the lower the fluctuation of blood sugar, the lower the risk of cardiovascular diseases because of the reduction in oxidative stress levels of the vascular endothelial cells.

“The results of the EVERGREEN clinical trial showed that Suganon significantly reduced the glycated hemoglobin level and improved the blood glucose fluctuation without severe adverse reactions, proving its efficacy in the early treatment of Korean type 2 diabetes patients,” a company official said.​​​​​

corea022@docdocdoc.co.kr

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