Safety and Efficacy of Modern Insulin Analogues.
10.4093/dmj.2013.37.3.181
- Author:
Hye Jin YOO
1
;
Keun Yong PARK
;
Kang Seo PARK
;
Kyu Jeung AHN
;
Kyung Wan MIN
;
Jeong Hyun PARK
;
Sang Ah CHANG
;
Bong Soo CHA
;
Dong Jun KIM
;
Yong Seong KIM
;
Tae Keun OH
;
Suk CHON
;
Il Seong NAM-GOONG
;
Mi Jin KIM
;
Hye Soon KIM
;
Young Sik CHOI
;
You Hern AHN
;
Sora LEE
;
Sei Hyun BAIK
Author Information
1. Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. 103hyun@korea.ac.kr
- Publication Type:Original Article
- Keywords:
Diabetes mellitus, type 2;
Insulin;
Republic of Korea;
Safety;
Treatment outcome
- MeSH:
Biphasic Insulins;
Body Weight;
Diabetes Mellitus, Type 2;
Drug Toxicity;
Fasting;
Glucose;
Hemoglobins;
Humans;
Incidence;
Insulin;
Insulin Aspart;
Insulin, Isophane;
Insulin, Long-Acting;
Patient Selection;
Plasma;
Quality of Life;
Republic of Korea;
Treatment Outcome;
Insulin Detemir
- From:Diabetes & Metabolism Journal
2013;37(3):181-189
- CountryRepublic of Korea
- Language:English
-
Abstract:
BACKGROUND: A1chieve(R) 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.
