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Safety and Efficacy of Modern Insulin Analogues

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Author(s)
Hye Jin YooKeun Yong ParkKang Seo ParkKyu Jeung AhnKyung Wan MinJeong Hyun ParkSang Ah ChangBong Soo ChaDong-Jun KimYong Seong KimTae Keun OhSuk ChonIl Seong Nam-GoongMi Jin KimHye-Soon KimYoung Sik ChoiYou Hern AhnSora LeeSei Hyun Baik
Keimyung Author(s)
Kim, Hye Soon
Department
Dept. of Internal Medicine (내과학)
Journal Title
Diabetes & Metabolism Journal
Issued Date
2013
Volume
37
Issue
3
Abstract
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.
Keywords: Diabetes mellitus, type 2; Insulin; Republic of Korea; Safety; Treatment outcome
Keimyung Author(s)(Kor)
김혜순
Publisher
School of Medicine
Citation
Hye Jin Yoo et al. (2013). Safety and Efficacy of Modern Insulin Analogues. Diabetes & Metabolism Journal, 37(3), 181–189. doi: 10.4093/dmj.2013.37.3.181
Type
Article
ISSN
2233-6079
DOI
10.4093/dmj.2013.37.3.181
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/35571
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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