Endocrinol Metab.  2020 Mar;35(1):142-148. 10.3803/EnM.2020.35.1.142.

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

• Yu HM
• Park KS
• Hong JH
• Park KY
• Lee JM
• Ku BJ
• Kim YJ
• Oh TK

• KMID: 2471730
• DOI: http://doi.org/10.3803/EnM.2020.35.1.142

Abstract

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.

Keyword

Hyperglycemia; Insulin; Algorithms; Diabetes mellitus, type 2

MeSH Terms

Blood Glucose
Diabetes Mellitus, Type 2*
Fasting
Humans
Hyperglycemia
Insulin Detemir*
Insulin*
Metformin
Self Care
Insulin
Insulin Detemir
Metformin

Figure

• 

  Fig. 1 Mean haemoglobin A1c (HbA1c) reduction by week during the trial. Changes in HbA1c from baseline to 20 weeks of treatment: HbA1c decreased similarly in the 3-0-3 algorithm group (−0.9% from 10.0% at baseline) and in the 2-4-6-8 algorithm group (−0.9% from 9.5% at baseline) after 20 weeks of treatment.

• 

  Fig. 2 Mean fasting plasma glucose (FPG) values by week during the trial. FPG was observed to decrease more in the 2-4-6-8 algorithm group (−74.3 mg/dL) than in the 3-0-3 algorithm group (−44.6 mg/dL) after 12 weeks of treatment. FPG decreased similarly in the 3-0-3 algorithm group (−60.4 mg/dL from 204.1 mg/dL at baseline) and in the 2-4-6-8 algorithm group (−56.4 mg/dL from 182.9 mg/dL at baseline) after 20 weeks of treatment.

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