The Korean TITRATION Study: Comparison of the Self-titration Methods for Glargine-300

A Korean, Single-center, Open-label, Randomized Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Patients With Type 2 Diabetes Mellitus

The aim of this study is to demonstrate efficacy and safety of self-titration algorithm with Gla-300 using the INSIGHT algorithm (once daily by 1 unit) and the EDITION algorithm (once weekly by 3 units) in Korean patients with T2D.

The primary objective of this study is to obtain efficacy and safety descriptive data on two different titration algorithms: the INSIGHT titration algorithm (self-titration of 1 unit/day) and the EDITION trial algorithm with insulin glargine 300 units/mL (GLA-300) when given as basal insulin in uncontrolled T2DM patients on basal insulin with or without non-insulin anti-hyperglycemic agent (NIAHA) or in insulin naïve patients.

In a Korean, single-center, type 2 diabetes patients with basal insulin therapy will be enrolled. They will be randomly assigned to either titration algorithm for GLA-300. After 12 weeks, the glycemic control, patients' satisfaction to the titration methods and healthcare providers' satisfaction to titration methods will be assessed.

Inclusion Criteria:

• Aged ≥ 19 years
• Treated for T2D for at least 6 months
• Uncontrolled T2D
• Use of SMPG
• HbA1c > 7% and ≤ 10% in patients with a basal insulin (Gla-100, Gla-300, neutral protamine Hagedorn (NPH), and detemir) or HbA1c > 7% and ≤ 11% in insulin naive patients
• Signed informed consent

Exclusion Criteria:

• Type 1 diabetes mellitus
• Pregnancy or lactation
• Night-shift worker
• Unwilling to inject insulin or perform SMPG
• Treated with insulin other than basal insulin within the previous 3 months
• Not on stable dose of basal insulin (±20%) in the last 3 months
• Initiation or change in dose of oral anti-hyperglycemic agents in the last 3 months
• History of alcohol or drug abuse
• Active cancer or other significant comorbidities which the investigator would make the patients unsuitable for participating in the study
• Any clinically significant laboratory finding which the which the investigator would make the patients unsuitable for participating in the study
• Known drug allergy to insulin
• Not signed informed consent
• Incompletion of the study
• Participating in another clinical trial