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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, Vol.31(1) : 68-75, 2014 
Journal Title
Issue Date
Biphasic Insulins/administration & dosage* ; Biphasic Insulins/pharmacokinetics ; Blood Glucose/drug effects* ; Blood Glucose/metabolism ; Blood Glucose Self-Monitoring ; Diabetes Mellitus, Type 2/drug therapy* ; Diabetes Mellitus, Type 2/metabolism ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Female ; Glycated Hemoglobin A/drug effects* ; Glycated Hemoglobin A/metabolism ; Humans ; Hypoglycemic Agents/administration & dosage* ; Hypoglycemic Agents/pharmacokinetics ; Male ; Middle Aged ; Prospective Studies ; Republic of Korea ; Time Factors ; Treatment Outcome
AIMS: Biphasic insulin analogues are widely used in patients with Type 2 diabetes mellitus suboptimally controlled on oral anti-diabetic drugs. Several topics in this area remain controversial, including how to divide the daily dose of biphasic insulin analogue. We aimed to determine the optimal dosing ratio of twice-daily biphasic insulin analogue and to compare the glycaemic efficacy among groups of patients using different initial dosing ratios of biphasic insulin analogue. METHODS: A total of 100 poorly controlled insulin-naive subjects with Type 2 diabetes [HbA1c ≥ 58 mmol/mol, (7.5%)] on oral anti-diabetic drugs were randomized into three groups according to initial morning:evening dosing ratio (group I, 50:50; group II, 55:45; group III, 60:40) of twice-daily biphasic insulin analogue (biphasic insulin aspart 70/30, biphasic insulin aspart 30). The primary outcome measure was the difference in pre-breakfast to pre-dinner dose ratio at the end of the study. RESULTS: Twice-daily biphasic insulin analogue showed a significant improvement in glycaemic control [HbA1c from 70 mmol/mol (8.6%) to 60 mmol/mol (7.6%)] after 24 weeks regardless of the initial dose ratio given. Despite the similar efficacy and safety profiles among three groups, morning dose was significantly increased (from 50:50 to 55:45-60:40) in group I after 24 weeks. However, there was no significant change in splitting ratio in groups II and III (with higher morning dose) over the 24-week treatment period. CONCLUSIONS: These results indicate that initiating twice-daily biphasic insulin analogue on regimens with a higher dose before breakfast than before dinner (i.e. ratio approximately 55:45 to 60:40) might be more appropriate in Korean subjects with Type 2 diabetes.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Lee, Byung Wan(이병완) ORCID logo https://orcid.org/0000-0002-9899-4992
Lee, Yong Ho(이용호) ORCID logo https://orcid.org/0000-0002-6219-4942
Cha, Bong Soo(차봉수) ORCID logo https://orcid.org/0000-0003-0542-2854
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