Diabetes & Metabolism Journal

Original Articles

Safety and Efficacy of Modern Insulin Analogues: Hye Jin Yoo, 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; Diabetes Metab J. 2013;37(3):181-189. Published online June 14, 2013; DOI: https://doi.org/10.4093/dmj.2013.37.3.181

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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.

Citations

Citations to this article as recorded by

Insulin therapy for adult patients with type 2 diabetes mellitus: a position statement of the Korean Diabetes Association, 2017
Byung-Wan Lee, Jin Hwa Kim, Seung-Hyun Ko, Kyu Yeon Hur, Nan-Hee Kim, Sang Youl Rhee, Hyun Jin Kim, Min Kyong Moon, Seok-O Park, Kyung Mook Choi
The Korean Journal of Internal Medicine.2017; 32(6): 967. CrossRef
Insulin Therapy for Adult Patients with Type 2 Diabetes Mellitus: A Position Statement of the Korean Diabetes Association, 2017
Byung-Wan Lee, Jin Hwa Kim, Seung-Hyun Ko, Kyu-Yeon Hur, Nan-Hee Kim, Sang Youl Rhee, Hyun Jin Kim, Min Kyong Moon, Seok-O Park, Kyung Mook Choi
Diabetes & Metabolism Journal.2017; 41(5): 367. CrossRef
An information and communication technology-based centralized clinical trial to determine the efficacy and safety of insulin dose adjustment education based on a smartphone personal health record application: a randomized controlled trial
Gyuri Kim, Ji Cheol Bae, Byoung Kee Yi, Kyu Yeon Hur, Dong Kyung Chang, Moon-Kyu Lee, Jae Hyeon Kim, Sang-Man Jin
BMC Medical Informatics and Decision Making.2017;[Epub] CrossRef
Characteristics Predictive for a Successful Switch from Insulin Analogue Therapy to Oral Hypoglycemic Agents in Patients with Type 2 Diabetes
Gyuri Kim, Yong-ho Lee, Eun Seok Kang, Bong-Soo Cha, Hyun Chul Lee, Byung-Wan Lee
Yonsei Medical Journal.2016; 57(6): 1395. CrossRef
Avoiding or coping with severe hypoglycemia in patients with type 2 diabetes
Jae-Seung Yun, Seung-Hyun Ko
The Korean Journal of Internal Medicine.2015; 30(1): 6. CrossRef
Clinical Characteristics of Patients Responding to Once-Daily Basal Insulin Therapy in Korean Subjects with Type 2 Diabetes
Sun Ok Song, You-Cheol Hwang, Kyu-Jeung Ahn, Bong Soo Cha, Young Duk Song, Dae Wook Lee, Byung-Wan Lee
Diabetes Therapy.2015; 6(4): 547. CrossRef
The optimal morning:evening ratio in total dose of twice‐daily biphasic insulin analogue in poorly controlled Type 2 diabetes: a 24‐week multi‐centre prospective, randomized controlled, open‐labelled clinical study
C. H. Jung, J.‐Y. Park, J. H. Cho, K.‐H. Yoon, H. K. Yang, Y.‐H. Lee, B. S. Cha, B.‐W. Lee
Diabetic Medicine.2014; 31(1): 68. CrossRef
The glycemic efficacies of insulin analogue regimens according to baseline glycemic status in Korean patients with type 2 diabetes: sub‐analysis from the A 1 chieve ® study
Y.‐C. Hwang, J. G. Kang, K. J. Ahn, B. S. Cha, S.‐H. Ihm, S. Lee, M. Kim, B.‐W. Lee
International Journal of Clinical Practice.2014; 68(11): 1338. CrossRef
Letter: Efficacy and Safety of Biphasic Insulin Aspart 30/70 in Type 2 Diabetes Suboptimally Controlled on Oral Antidiabetic Therapy in Korea: A Multicenter, Open-Label, Single-Arm Study (Diabetes Metab J2013;37:117-24)
Byung-Wan Lee
Diabetes & Metabolism Journal.2013; 37(3): 212. CrossRef

The Role of Chromium as an Insulin Sensitizer in Rats Receivieng Corticosteroid.: Dong Sun Kim, Chang Beom Lee, Yong Soo Park, You Hern Ahn, Tae Wha Kim, Ho Soon Choi, Il Kyu Park, Hyun Jin Shin, Ju Seop Kang; Korean Diabetes J. 2001;25(3):211-217. Published online June 1, 2001

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Abstract PDF: BACKGROUND
Chromium (Cr) has been known to be essential for the regulation of insulin action. Recently it has been reported that corticosteroid increases urinary loss of Cr, and that Cr supplementation recovers steroid induced diabetes mellitus. METHODS: Rats were daily treated with dexamethasone (0.2 mg/kg, ip) for first 7 days and were further treated daily with dexamethasone plus either chromium picolinate (30 mg/kg) or a placebo for a period of 14 days. RESULTS: At the end of experiment (Day 21), the control rats treated only with dexamethasone weighed 320 gram (80% of initial weight) in average, but the Cr treated rats weighed 364 gram (91% of initial weight. p<0.05). An insulin sensitivity test [subcutaneous injection of insulin (5 U/kg) plus intraperitoneal injection of glucose (30 minutes after insulin injection)] were conducted. During the insulin sensitivity tests, the area under curves (AUC(0->120 min)) of the time-glucose concentrations curves in the Cr-treated group were decreased compared to those in the control group (5250 vs 15883 mg-min/dL, p<0.01). Fasting serum insulin levels in the Cr-treated rats were clearly decreased by 46.9% compared to those in the control group (2.98 vs 5.60 ng/mL, p<0.05). CONCLUSIONS: We conclude that chromium supplementation reverse a catabolic state, and increase insulin sensitivity in dexamethasone treated rats.

Prevalence of ICA and anti-GAD, HLA DRB1 / DQA1 / DQB1 Polymorphism in Korean IDDM Patients.: Yong Soo Park, Jin Ho Shin, Jin Bae Kim, Woong Hwan Choi, You Hern Ahn, Tae Wha Kim, Mok Hyun Kim, Sei Won Yang, Seung Duck Hwang, Hee Bal Rhee; Korean Diabetes J. 1997;21(3):289-299. Published online January 1, 2001

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Abstract PDF: BACKGROUND
Although the HLA class II genes are cleaily associated with insulin-dependent diabetes mellitus(IDDM) in all ethnic. Groups, considerable variation in the associated genotypes is observed among the different ethnic groups. Mathods: In order to estimate what degree genetic and environmental determinants influence the true incidence of IDDM, ICA by imrnunohistochemistry, anti-GAD prevalence by radioimmunoprecipitation and HLA-DRB1, DQAl, and DQB1 polymorphisms after PCR amplification of genomic DNA were analyzed in 131 cases of IDDM, whose age at diagnosis were less than 15. RESULTS: 56% of them(73/131) were anti-GAD positive. 43% IDDM(56/131) were ICA positive. HLA DR3 and DR9 were susceptibility markers, whereas DR2 and DR5 were protective markers. DR3/4,, DR3/9, and DR3/X(X: other than 3, 4) were susceptible genotypes. HLA DQA1*0301 allele was increased, and DQB1*0301 and DQB1*0602 were decreased in IDDM. Not only HLA DQA1 Arg, but also DQBl non-Asp were found to be independent marker for IDDM, but their strength of association was weak. The highest prevalence of anti-GAD was observed in thosc homozygous for DR4(87.5%), exceeding that(47.8%) in those without this allele, and those with one DR4(63.5), whereas the highest prevealence of ICA was found in those homozygous for DR3(10G%), exceeding that in those with one DR3(64.3%) or in those without this allele(36.7%). There was a significant difference in numbers of HLA DQ susceptibility heterodimers in anti-GAD positive or negative patients. Conelusion: The prevalence of islet-specific auto-antibodies were present at comparable sensitivity and specificity in Korean IDDM patients. We could also assess that the immunoenetic markers for IDDM among Caucasians likewise confer disease susceptibility among Koreans. However, different HLA susceptibility alleles and a lower strength of association with known susceptibility markers, presumably because of differences in the genetic make-up of the population or in linkage disequilibrium patterns compared with other racial groups.

Autophosphorylation and tyrosine kinase activity of purified insulin receptors.: Woong Hwan Choi, You Hern Ahn, Tae Wha Kim, Mokhyun Kim; Korean Diabetes J. 1991;15(2):173-182. Published online January 1, 2001

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Abstract PDF: No abstract available.

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