초록 ▼

DW1029M의 원료 생약인 갈근과 상백피의 유전학적 및 이화학적 표준화 규격화 연구를 완료하였으며, 원료의약품 및 제품의 대량생산 공정연구를 완료하였다. 또한 당뇨병성 신증 환자 빈용 약물 3종과의 임상 1상 약물 상호 작용연구를 통해 DW1029M(1200mg/day)이 Metformin(1000mg/day), Losartan(50mg/day) 및 Linagliptin(5 mg/day)과 병용투여 시 DW1029M 이 각 3종의 약물의 약동학적 특성에 미미한 영향을 주는 것으로 평가하였다. 임상 2상 연구는 당뇨병 유병기간이 6

DW1029M의 원료 생약인 갈근과 상백피의 유전학적 및 이화학적 표준화 규격화 연구를 완료하였으며, 원료의약품 및 제품의 대량생산 공정연구를 완료하였다. 또한 당뇨병성 신증 환자 빈용 약물 3종과의 임상 1상 약물 상호 작용연구를 통해 DW1029M(1200mg/day)이 Metformin(1000mg/day), Losartan(50mg/day) 및 Linagliptin(5 mg/day)과 병용투여 시 DW1029M 이 각 3종의 약물의 약동학적 특성에 미미한 영향을 주는 것으로 평가하였다. 임상 2상 연구는 당뇨병 유병기간이 6년 이상인 150여명의 당뇨병성 신증 환자를 대상으로 실시하였으며, 위약 대조로 시험약 DW1029M 600 mg/day 및 1200mg/day 투여 24주 시점의 ACR 변화량이 각각 123.62± 331.24 ㎍/mg 과 87.55± 349.79 ㎍/mg으로 위약군에서의 변화량 32.69± 135.30 ㎍/mg 대비하여 통계적으로 유의한 차이가 없음을 확인하였다.

Abstract ▼

Ⅰ. The purpose and need for research and development
In modern society, rapid westernization and aging induced several metabolic diseases like diabete, hypertension,hyperlipidemia and their complications. Nephropathy can caused by diabete, hypertension, hyperlipidemia but the mechanism is still u

Ⅰ. The purpose and need for research and development
In modern society, rapid westernization and aging induced several metabolic diseases like diabete, hypertension,hyperlipidemia and their complications. Nephropathy can caused by diabete, hypertension, hyperlipidemia but the mechanism is still unknown. Only restricted medications are being administered in clinical trial of hypertensional nephropathy such as ACE inhibitior (captopril), ARBs (losartan, telmisartan). Many research groups are studying to figure out the mechanism of chronic renal failure. In this situation, our team discovered DW1029M, dual natural product extract, effective in various renal failure assay model.
II. Contents of research
In the 10 institutions it was carried out late Phase II clinical trials for type 2 diabetic nephropathy in DW1029M. The research contents as follows performed prior Phase II studies..
①The stability tests of the product and API. ②The process validation tests.③The formulation tests. ④The tests of Test Methods for evaluating the quality of the product and API. ⑤The tests of the mechanisms and active substances. In the Phase 2b clinical studies the following results up to the present in the list. ①The stability tests : the accelerated test and long-term preservation test of products and APIs are underway . ②The process validation tests : improve the quality through repeated scale-up processing ③The formulation tests : the studies of the content and formulation are completed. ④The tests of Test Methods : improve the quality of the test Methods, the study of Standardization on the raw materials are executed. ⑤The tests of the mechanisms and active substances. : the study of the kidney-related mechanisms and additional studies about enzyme experiments and the search for the active substance are conducted.
III. Clinical Study result
Metformin 1000 mg / day and DW1029M 1200 mg / day, Losartan 50 mg / day and DW1029M 1200 mg / day and Linagliptin 5 mg / day and DW1029M 1200 mg / day when administered in combination DW1029M were evaluated as having a negligible effect on the pharmacokinetic properties of metformin, losartan and Linagliptin.
Phase II study was conducted among diabetic nephropathy patients(n≥ 150) with diabetes duration of more than six years. In this trial DW1029M 600 mg, 1200 mg and the plcebo group, the ACR change of those groups at 24 weeks are 123.62 ± 331.24 ㎍/mg, 87.55 ± 349.79㎍/mg and 32.69 mg ± 135.30㎍/mg respectively. Statistically there was no significant difference between the test group and the placebo group.