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KMID : 1141520200350010142
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Endocrinology and Metabolism
2020 Volume.35 No. 1 p.142 ~ p.148
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Comparison of the Efficacy and Safety of Insulin Detemir Administered Once Daily According to Two Titration Algorithms (3-0-3 and 2-4-6-8) in Patients with Type 2 Diabetes Mellitus
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Yu Hea-Min
Park Kang-Seo
Hong Jun-Hwa
Park Keun-Yong
Lee Jong-Min
Ku Bon-Jeong
Kim Yeo-Joo
Oh Tae-Kun
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Abstract
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Background: This study was conducted to compare glycaemic control with insulin detemir administered according to two titration algorithms (3-0-3 and 2-4-6-8) after 20 weeks of treatment in subjects with type 2 diabetes mellitus inadequately controlled on metformin.
Methods: This was a 20-week, randomised, multicentre, open-labelled, treat-to-target trial. Forty-six patients were randomised in a 1:1 manner to either the 3-0-3 (G3, n=23) or 2-4-6-8 (G2, n=23) algorithm. The primary endpoint was change of haemoglobin A1c (HbA1c), and the secondary safety endpoint included hypoglycaemic events.
Results: After 20 weeks, HbA1c decreased similarly in the G3 and G2 groups, with a mean change of ?0.9% from baseline. The mean change in fasting plasma glucose was numerically similar in both groups. The hypoglycaemia event rate per 100-patient-years of exposure (r) in the G2 group (r=1,427) was higher than that in the G3 group (r=807).
Conclusion: Both treatment groups had numerically similar HbA1c reductions. A trend towards fewer hypoglycaemia episodes after dose stabilisation was seen with the simpler G3. Clinically, this may be an important observation, as a simpler titration algorithm may support self-management and maintenance of insulin therapy.
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KEYWORD
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Hyperglycemia, Insulin, Algorithms, Diabetes mellitus, type 2
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