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

CompletedNA

Sponsor: Seoul National University Hospital

Conditions: Type 2 Diabetes Mellitus

Interventions: Group 1, Group 2

Countries: South Korea

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.

Eligibility overview

Sex: ALL

Age: 19 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Seoul, South Korea