Status:
COMPLETED
The Korean TITRATION Study: Comparison of the Self-titration Methods for Glargine-300
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
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 unit...
Detailed Description
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 EDIT...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2020
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT03406663
Start Date
October 1 2017
End Date
July 14 2020
Last Update
October 22 2020
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744