On November 27, Dong-A ST (Chairman Eom Dae-sig) announced that the results of the clinical trial of its diabetes treatment Suganon EVERGREEN were by Professor Kim Gyu-ri of the Internal Medicine Department of Samsung Medical Center at the 12th IDF-WPR CONGRESS & 10th AASE Scientific Meeting held on November 25 in Kuala Lumpur, Malaysia.

The EVERGREEN clinical trial compared the efficacy, safety and amplitude of glycemic excursions of Evogliptin and Linagliptin in Korean type 2 diabetic patients who had not previously experienced diabetes medications in order to confirm the ‘usefulness in the initial treatment of type 2 diabetic patients’ of the DPP-4 inhibitor Suganon (Generic Name: Evogliptin).

In this clinical trial, patients with type 2 diabetes over 20 years of age who had 7.0%~10.0% of HbA1c, and who did not take oral hypoglycemic agents for at least 8 weeks before the trial, were divided into two groups, i.e. the Evogliptin group and the Linagliptin group, and treated with the assigned drug for 12 weeks for the purpose of comparison. A total of 207 patients participated in the clinical trials held at 19 medical institutions from September 2016 to May 2018.

In the primary efficacy evaluation of the clinical trial, the presence of HbA1c in the Evogliptin group and the Linagliptin group decreased significantly by 0.85% and 0.75%, respectively, after 12 weeks of treatment, demonstrating the non-inferiority of Evogliptin compared to Linagliptin. In the secondary efficacy evaluation, the response rates of HbA1c < 7.0% were 68.0% and 67.3%, respectively, and the response rates of HbA1c < 6.5% were 44.0% and 36.5%, respectively, showing no statistically significant difference between the two groups.

The results of the safety assessment showed that both drugs are safe to take without serious adverse events. Unlike the Evogliptin group, one case of symptomatic hypoglycemia and three cases of salvage Metformin treatment due to failure to meet the target glycemic level were observed in the Linagliptin group. However, there was no statistically significant difference between the two groups.

In the results of measuring the improvement effect of the amplitude of glycemic excursions, the MAGE (Mean Amplitude of Glycemic Excursions) after 12 weeks of treatment was 24.6mg/dL for Evogliptin and 16.7mg/dL for Linagliptin. In general, it is known that the lower the amplitude of glycemic excursions, the lower the risk of cardiovascular disease due to a reduction of oxidative stress in the vascular endothelial cells.

The levels of convenience and medication adherence of Suganon, the 26th new drug in Korea developed by Dong-A ST, are high in patients with chronic illness who need to take multiple medications, as it shows high selectivity for the DPP-4 enzyme and exhibits an excellent glycaemia-lowering effect even with small doses, while having little effect on the metabolism of other medications. It offers a further advantage in that it can be used without adjusting the dose for patients with reduced renal function.

An official from Dong-A ST said, “The EVERGREEN clinical trial proved Suganon to be beneficial in the early treatment of Korean type 2 diabetic patients, confirming a significant reduction of HbA1c and an improvement of the amplitude of glycemic excursions without any severe adverse events. We will strive to promote the superiority of Suganon at home and abroad by continuously obtaining additional data on its efficacy and safety.”