Effect and Safety of Replacement Therapy with Insumon in Type 2 Diabetes Mellitus

제2형 당뇨병 환자에 대한 대체 요법 [인슈몬]의 효과 및 안전성

  • 홍억기 (강원대학교 바이오산업공학부) ;
  • 김재수 (㈜내츄럴엔도텍) ;
  • 박준홍 (㈜내츄럴엔도텍) ;
  • 박세정 (㈜내츄럴엔도텍) ;
  • 장학철 (삼성제일병원 내분비내과) ;
  • 한인권 (삼성제일병원 내분비내과, 성균관대학교 의과대학)
  • Published : 2003.08.01

Abstract

This research was concentrated to Investigate the effects of Insumon as a newly developed dietary supplement in patients with type 2 diabetes. The average glycated hemoglobin level was dropped from 7.0${\pm}$1.1% to 6.7${\pm}$0.9% after 8 weeks with statistic significance (p=0.0202). For patients of HbA1c over 7%, the average HbA1c significantly decreased from 8.1${\pm}$0.8% to 7.5${\pm}$0.8% (p=0.0171). The average fasting blood glucose level was decreased significantly from 9.5${\pm}$1.2 mmol/L (171.6${\pm}$22.3 mg/dL) to 8.5${\pm}$1.5 mmol/L (152.3${\pm}$26.3 mg/dL) (p=0.0262) after 4 weeks and to 8.8${\pm}$1.5 mmol/L (158.3${\pm}$24.1 mg/dL) (p=0.0445) after 8 weeks in the group of patients of FBG of over 7.8 mmol/L (140 mg/dL). The average HDL cholesterol level was increased significantly after 8 weeks from 1.2${\pm}$0.2 mmol/L (46.5${\pm}$8.6 mg/dL) to 1.3${\pm}$0.3 mmol/L (51.6${\pm}$10.9 mg/dL) (p=0.0007). Thus, these results suggested that patients with type 2 diabetes might benefit by Insumon as a herbal dietary supplement without any serious side effects.

전반적인 유효율은 1차 유효성 평가항목인 당화혈색소가 0주 평균 7.0$\pm$1.1%에서 8주간 인슈몬 투여후 6.7$\pm$0.9%로 유의하게 감소하였으며 (p=0.0202), 특히 혈당 조절이 잘 되지 않는 당화혈색소 7.0% 초과(기저치)군에서도 0주 평균 8.1$\pm$0.8%에서 4주 투여후 7.7$\pm$0.7%로, 8주 투여 후 7.5$\pm$0.8%로 유의하게 감소하였다(p=0.0171). 당화혈색소 7%이하인 군에서도 유의차는 보이지 않으나 0주 평균 6.2$\pm$0.3%에서 8주 투여 후 6.2$\pm$0.6%로 다소 감소하여 당화혈색소가 7% 이하로 잘 유지되고 있음을 보여주었다. 본 연구를 통하여 당뇨병 관리를 목적으로 의약품이 아닌 기능성 식품의 대체요법에 대한 평가가 이루어진 전례가 거의 없는 상황에서 천연식물 추출물을 주원료로 한 기능성 식품인 인슈몬의 유효성과 안전성을 평가함으로써 제2형 당뇨병 개선에 많은 도움이 되리라 사료된다.

Keywords

References

  1. Kor. J. Med. Hist. v.36 The present state and the changes of a cause of the death in Korea Kim,J.S.
  2. Diabetes v.20 Probability of the diabetes at Yeoncheon in Gyeonggi-do Shin,C.S.;H.K.Kim;W.B.Kim;K.S.Park;S.Y.Kim;B.Y.Cho;H.K.Lee;C.S.Ko;Y.I.Kim;Y.S.Shin;H.Y.Bak;T.K.Oh;Y.S.Park;B.K.Yang
  3. Investigation of the actual conditions for the sick and wounded in 2001 Korea Institute for Health and Social Affair Ministry of Health and Welfare
  4. Lancet v.352 Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes United Kingdom Prospective Diabetes Study Group. UKPDS 33 https://doi.org/10.1016/S0140-6736(98)07019-6
  5. Diabetes v.23 SDM in complications of diabetes mellitus Park,J.H.
  6. New Eng. J. Med. v.329 The Effect of intensive treatment of diabetes on the development and progression of long term complications in insulin-dependent diabetes mellitus The Diabetes Control and Complications trial Research Group https://doi.org/10.1056/NEJM199309303291401
  7. Diabetes Res. Pract. v.28 Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non insulin dependent diabetes mellitus: a randomized prospective 6-year study Ohkubo,Y.;H.Kishikawa;E.araki;T.Miyata;S.Isami;S.Motoyoshi;Y.Kojima;N.Furuyoshi;M.Shichiri https://doi.org/10.1016/0168-8227(95)01064-K
  8. Diabetes care v.18 Hyperglycemia and microvascular and macrovascular disease in diabetes Klein,R. https://doi.org/10.2337/diacare.18.2.258
  9. Diabetes v.43 NiDDM and its metabolic control predict coronary heart disease in elderly subjects Kuusisto,J.;L.Mykkanen;K.Pyorala;M.Laasko https://doi.org/10.2337/diabetes.43.8.960
  10. Ann. Intern. Med. v.92 Monitoring metabolic control in diabetic outpatients with glycosylated hemoglobin Boden,G.;R.W.Master;S.S.Gordon;C.R.Shuman;O.E.Owen https://doi.org/10.7326/0003-4819-92-3-357
  11. New Engl. J. Med. v.310 The clinical information value of the glycosylated hemoglobin assay Nathan,D.M.;D.E.Singer;K.Hurthal;J.Goodson https://doi.org/10.1056/NEJM198402093100602
  12. Lancet v.352 Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes United Kingdom Prospective Diabetes Study Group. UKPDS 34 https://doi.org/10.1016/S0140-6736(98)07037-8
  13. British Med. J. v.317 Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes United Kingdom Prospective Diabetes Study Group. UKPDS 39 https://doi.org/10.1136/bmj.317.7160.713
  14. Diabetes v.12 Effect of metrofin for patients with type 2 diabetes Kim,Y.J.;E.I.Lee,K.W.Lee;S.K.Lim;H.C.Lee;K.B.Hur
  15. Am. J. Med. v.70 The pharmacology of sulfonylurea Skillman,T.G.;J.M.Feldman https://doi.org/10.1016/0002-9343(81)90773-7
  16. Diabetes Care v.17 Therapeutic comparison of metformin and sulfonylurea, alone and in various combinations Herman,L.S.;B.Scherstein;P.Bitzen;T.Kjellstrom;F.Lindgerde;A.Melander https://doi.org/10.2337/diacare.17.10.1100
  17. Clinical Diabetes v.13 A new oral therapy for diabetes management: alpha-glucosidase inhibiton with acarbose Lebovitz,H.
  18. Diatetes v.18 no.Appendix 1 The actual conditions of a folk remedy for diatetes Kim,K.R.
  19. Archives of Internal Medicine v.154 no.21 Long-term efficacy and safety of acarbose in the treatment of obese subjects with non-insulin-dependent diabetes mellitus Coniff,R.F.;J.A.Shapiro;T.B.Seaton https://doi.org/10.1001/archinte.154.21.2442
  20. Medical Science Monitor v.9 no.6 Long-term efficacy of steady-dose metformin in type 2 diabetes mellitus: a retrospective study Drzewoski,J.;L.Czupryniak