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KMID : 1200020130370030181
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Diabetes & Metabolism Journal
2013 Volume.37 No. 3 p.181 ~ p.189
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Safety and Efficacy of Modern Insulin Analogues
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Yoo Hye-Jin
Park Keun-Yong
Park Kang-Seo
Ahn Kyu-Jeung
Min Kyung-Wan
Park Jeong-Hyun
Chang Sang-Ah
Cha Bong-Soo
Kim Dong-Jun
Kim Yong-Seong
Oh Tae-Keun
Chon Suk
NamGoong Il-Seong
Kim Mi-Jin
Kim Hye-Soon
Choi Young-Sik
Ahn You-Hern
Lee So-Ra
Baik Sei-Hyun
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Abstract
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Background: A1chieve® was a noninterventional study evaluating the clinical safety and efficacy of biphasic insulin aspart 30, insulin detemir, and insulin aspart.
Methods: Korean type 2 diabetes patients who have not been treated with the study insulin or have started it within 4 weeks before enrollment were eligible for the study. The patient selection and the choice of regimen were at the discretion of the physician. The safety and efficacy information was collected from the subjects at baseline, week 12, and week 24. The number of serious adverse drug reactions (SADRs) was the primary endpoint. The changes of clinical diabetic markers at week 12 and/or at week 24 compared to baseline were the secondary endpoints.
Results: Out of 4,058 exposed patients, 3,003 completed the study. During the study period, three SADRs were reported in three patients (0.1%). No major hypoglycemic episodes were observed and the rate of minor hypoglycemic episodes marginally decreased during 24 weeks (from 2.77 to 2.42 events per patient-year). The overall quality of life score improved (from 66.7±15.9 to 72.5±13.5) while the mean body weight was slightly increased (0.6±3.0 kg). The 24-week reductions in glycated hemoglobin, fasting plasma glucose and postprandial plasma glucose were 1.6%±2.2%, 2.5±4.7 mmol/L, and 4.0±6.4 mmol/L, respectively.
Conclusion: The studied regimens showed improvements in glycemic control with low incidence of SADRs, including no incidence of major hypoglycemic episodes in Korean patients with type 2 diabetes.
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KEYWORD
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Diabetes mellitus, type 2, Insulin, Republic of Korea, Safety, Treatment outcome
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