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.

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.

• Authors: Hea Min Yu, Kang Seo Park, Jun Hwa Hong, Keun Yong Park, Jong Min Lee, Bon Jeong Ku, Yeo Joo Kim, Tae Kun Oh
• Journal: Endocrinology and metabolism (Seoul, Korea) (Endocrinol Metab (Seoul)) Vol. 35 Issue 1 Pg. 142-148 (03 2020) ISSN: 2093-5978 [Electronic] Korea (South)
• PMID: 32207274 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020 Korean Endocrine Society.

Chemical References

• Biomarkers
• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• hemoglobin A1c protein, human
• Insulin Detemir

Topics

• Adult
• Aged
• Algorithms
• Biomarkers (analysis)
• Blood Glucose (analysis)
• Diabetes Mellitus, Type 2 (blood, drug therapy, pathology)
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Glycated Hemoglobin (analysis)
• Humans
• Hypoglycemic Agents (administration & dosage)
• Insulin Detemir (administration & dosage)
• Male
• Middle Aged
• Prognosis