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손태서,이지인,김인주,민경완,손현식 대한당뇨병학회 2008 Diabetes and Metabolism Journal Vol.32 No.5
Background: Type 2 diabetes is usually preceded by a long and clinically silent period of increasing insulin resistance. The purpose of this study is to demonstrate that rosiglitazone and metformin fixed-dose combination therapy (RSG/MET) will safely and effectively control glycemia as a first line of oral therapy, better than rosiglitazone (RSG) or metformin (MET) monotherapy in Korean type 2 diabetes patients. Methods: This study was a 32-week, multicenter, randomized, double-blind study. Twenty-seven type 2 diabetes patients (males 14; females 13) were included and randomly divided into the rosiglitazone, metformin group, or rosiglitazone /metformin combination groups. The primary objective of this study was to determine the change in HbA1c from baseline (week 0) to week 32. The secondary end-points were to determine changes in fasting plasma glucose (FPG) and homeostasis model assessment insulin resistance (HOMA-IR), from baseline to week 32. Other cardiovascular risk markers were also assessed. Results: At week 32, there were significant reductions in HbA1c and FPG, in all three treatment groups. There was no statistical difference in HbA1c among the three groups, but the decrease in FPG in the RSG/MET group was statistically significant compared to the MET group (P < 0.05). RSG/MET significantly reduced HOMA-IR at week 32 compared to baseline, but there was no difference among the three groups. RSG/MET significantly decreased high-sensitive C-reactive protein (hs-CRP) value at week 32, compared to baseline. There were increases in adiponectin from baseline to week 32 in the RSG and RSG/MET groups, and the increase in the RSG/MET group was statistically significant compared to that of the MET group (P < 0.05). At week 32, there was a significant decrease in plasminogen activator inhibitor-1 (PAI-1) in all three treatment groups, but no statistically significant difference among them. The RSG/MET group significantly decreased in terms of urinary albumin-creatinine ratio at week 32, compared to baseline. Conclusions: In this study, rosiglitazone and metformin combination therapy was effective in glycemic control as an initial therapy, and it improved cardiovascular risk markers in Korean type 2 diabetes patients. (KOREAN DIABETES J 32:445-452, 2008) 연구배경: 제2형 당뇨병은 발병 전에 일반적으로 오랜 기 간 동안 임상적으로 증상이 나타나지 않는 인슐린저항성이 선행한다. 본 연구의 목적은 한국인 제2형 당뇨병환자를 대 상으로 초기 치료로 고정 용량의 로지글리타존/메트포르민 복합 투여와 로지글리타존, 메트포르민 단독 투여를 비교하 여 혈당 강하 유효성을 평가하고자 하였다. 방법: 본 연구는 32주 동안 다기관, 무작위, 이중 맹검 방 법으로, 27명의 제2형 당뇨병환자를 대상으로 하였다. 대상 환자들은 로지글리타존, 메트포르민, 로지글리타존/메트포 르민 복합제 3군으로 무작위 배정하였다. 본 연구의 일차 목표로 약제 투여 32주 후 기준 시점으로부터의 당화혈색소 변화를 보고자 하였고, 이차 목표는 공복 혈장 혈당, HOMA -IR (Homeostasis model assessment insulin resistance), 기 타 심혈관계 위험 인자의 변화를 비교하는 것이었다. 결과: 약제 투여 32주 후, 3군 모두에서 당화혈색소, 공 복 혈장 혈당이 기준 시점에 비해 의미 있게 감소하였다. 당 화혈색소 감소에 대해 각 군 간에 의미 있는 차이는 없었지 만 공복 혈장 혈당 감소는 복합제군에서 메트포르민군 보다 의미 있게 감소하였다 (P < 0.05). 복합제군에서 HOMA -IR이 기준 시점에 비해 감소하였지만 다른 군과는 차이가 없었다. hs-CRP (high sensitive C-reactive protein)는 복합 제군에서 기준 시점에 비해 감소하였다. 로지글리타존군과 복합제군에서 adiponectin이 증가하였고 복합제군의 경우 메트포르민군에 비해 의미 있게 증가하였다 (P < 0.05). 각 군 간의 차이는 없었지만 PAI-1 (plasminogen activator inhibitor-1)은 3군 모두에서 기준 시점에 비해 감소하였다 (P < 0.05). 결론: 로지글리타존과 메트포르민 복합 제제는 한국인 제 2형 당뇨병환자에서 초기 치료로써 혈당 조절에 효과적이었 고 심혈관계 위험 인자들을 개선시켰다.
혈당 조절이 되지 않는 제2형 당뇨병환자에서 로지글리타존과 메트포르민 병합요법의 유효성
손태서,이지인,김인주,민경완,손현식 대한당뇨병학회 2008 Diabetes and Metabolism Journal Vol.32 No.6
Background: Obese type 2 diabetic subjects are recently increasing in Korea, indicating the importance of insulin resistance rather than insulin secretory defects in the pathophysioloy of type 2 diabetes. The purpose of this study is to evaluate the safety and efficacy of fixed dose rosiglitazone/metformin combination therapy in poorly controlled subjects with type 2 diabetes mellitus. Methods: 12 type 2 diabetic subjects who had a HbA1c > 11% or fasting plasma glucose > 15 mmol/L were included. After a 2 week screening period, the subjected took the fixed does rosiglitazone/metformin for 24 weeks. The treatment with rosiglitazone/metformin began at week 0 with an initial dose of 4 mg/1000 mg and, unless tolerability issues arose, subjects would be increased to 6 mg/1500 mg at week 4 and at week 8 to the maximum dose of 8 mg/2000 mg. The primary object of this study was to characterize the magnitude of HbA1c reduction from baseline after 24 weeks of rosiglitazone and metformin treatment in poorly controlled type 2 diabetics. Results: The mean age of the subjects was 48.9 ± 10.6 years old, body mass index was 25.0 ± 3.5 kg/m2, HbA1c was 12.0 ± 1.0%, and fasting plasma glucose was 16.3 ± 3.1 mmol/L. HbA1c was reduced to 7.54 ± 1.45% and fasting plasma glucose reduced to 7.96 ± 2.38 mmol/L at week 24. The proportion of HbA1c responder who showed the reduction from baseline of ≥ 0.7% or HbA1c < 7% was 11 among 12 subjects (91.7%). 41% of the subjects (5 among 12 subjects) achieved HbA1c level < 7.0% and 75% (9 among 12 subjects) achieved HbA1c level < 8.0%. Conclusions: In this study, rosiglitazone and metformin combination therapy was effective in glycemic control in poorly controlled subjects with type 2 diabetes mellitus. (KOREAN DIABETES J 32:506-512, 2008) Background: Obese type 2 diabetic subjects are recently increasing in Korea, indicating the importance of insulin resistance rather than insulin secretory defects in the pathophysioloy of type 2 diabetes. The purpose of this study is to evaluate the safety and efficacy of fixed dose rosiglitazone/metformin combination therapy in poorly controlled subjects with type 2 diabetes mellitus. Methods: 12 type 2 diabetic subjects who had a HbA1c > 11% or fasting plasma glucose > 15 mmol/L were included. After a 2 week screening period, the subjected took the fixed does rosiglitazone/metformin for 24 weeks. The treatment with rosiglitazone/metformin began at week 0 with an initial dose of 4 mg/1000 mg and, unless tolerability issues arose, subjects would be increased to 6 mg/1500 mg at week 4 and at week 8 to the maximum dose of 8 mg/2000 mg. The primary object of this study was to characterize the magnitude of HbA1c reduction from baseline after 24 weeks of rosiglitazone and metformin treatment in poorly controlled type 2 diabetics. Results: The mean age of the subjects was 48.9 ± 10.6 years old, body mass index was 25.0 ± 3.5 kg/m2, HbA1c was 12.0 ± 1.0%, and fasting plasma glucose was 16.3 ± 3.1 mmol/L. HbA1c was reduced to 7.54 ± 1.45% and fasting plasma glucose reduced to 7.96 ± 2.38 mmol/L at week 24. The proportion of HbA1c responder who showed the reduction from baseline of ≥ 0.7% or HbA1c < 7% was 11 among 12 subjects (91.7%). 41% of the subjects (5 among 12 subjects) achieved HbA1c level < 7.0% and 75% (9 among 12 subjects) achieved HbA1c level < 8.0%. Conclusions: In this study, rosiglitazone and metformin combination therapy was effective in glycemic control in poorly controlled subjects with type 2 diabetes mellitus. (KOREAN DIABETES J 32:506-512, 2008)