Diabetes Metab J > Volume 32(6); 2008 > Article
Korean Diabetes Journal 2008;32(6):506-512.
DOI: https://doi.org/10.4093/kdj.2008.32.6.506    Published online December 1, 2008.
The Efficacy of Fixed Dose Rosiglitazone and Metformin Combination Therapy in Poorly Controlled Subjects with Type 2 Diabetes Mellitus.
Tae Seo Sohn, Jee in Lee, In Ju Kim, Kyung Wan Min, Hyun Shik Son
1Department of Internal Medicine, The Catholic University of Korea, Korea.
2Department of Internal Medicine, The Pusan National University School of Medicine, Korea.
3Department of Internal Medicine, Eulji University College of Medicine, Korea.
Abstract
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 > or = 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.
Key Words: Metformin, Rosiglitazone, Type 2 diabetes


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