Safety and Efficacy of Modern Insulin AnaloguesSafety and Efficacy of Modern Insulin Analogues
- Other Titles
- Safety and Efficacy of Modern Insulin Analogues
- Authors
- 류혜진; 박근용; 박강서; 안규정; 민경완; 박정현; 장상아; 차봉수; 김동준; 김용성; 오태근; 전숙; 남궁일성; 김미진; 김혜순; 최영식; 안유헌; 이소라; 백세현
- Issue Date
- 2013
- Publisher
- 대한당뇨병학회
- Keywords
- Diabetes mellitus; type 2; Insulin; Republic of Korea; Safety; Treatment outcome
- Citation
- Diabetes and Metabolism Journal, v.37, no.3, pp.181 - 189
- Indexed
- SCOPUS
KCI
- Journal Title
- Diabetes and Metabolism Journal
- Volume
- 37
- Number
- 3
- Start Page
- 181
- End Page
- 189
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/105771
- DOI
- 10.4093/dmj.2013.37.3.181
- ISSN
- 2233-6079
- 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 24compared 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±15.9to 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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Collections - College of Medicine > Department of Medical Science > 1. Journal Articles
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