Clinical trial NCT03406663: The Korean TITRATION Study: Comparison of the Self-titration Methods for Glargine-300
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Insulin
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2018-01-23
Enrollment: 130
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 units) in Korean patients with T2D.

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 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.

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

Primary outcomes:
measure: Proportion of patients achieving fasting SMPG ≤ 5.6 mmol/L without hypoglycemia at 12 weeks
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Changes in HbA1c (%)
timeFrame: up to 12 weeks
measure: Fasting plasma glucose (mmol/L)
timeFrame: up to 12 weeks
measure: Fasting SMPG (mmol/L)
timeFrame: up to 12 weeks
measure: 7-point SMPG (mmol/L)
timeFrame: up to 12 weeks
measure: Proportion of patients at HbA1c ≤ 7%
timeFrame: up to 12 weeks
measure: Change in insulin dose (IU)
timeFrame: up to 12 weeks
measure: Change in body weight (kilogram)
timeFrame: up to 12 weeks
measure: Hypoglycemia (number of patients)
timeFrame: up to 12 weeks
measure: Adverse events
timeFrame: up to 12 weeks
measure: Patient satisfaction to the insulin titration method (evaluated by prespecified questionnaire: DTSQs)
timeFrame: up to 12 weeks
measure: Health care professionals' satisfaction to the insulin titration methods (evaluated by prespecirfied questionnaire: health care provider treatment satisfaction questionnaire)
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Young Min Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bae JH, Ahn CH, Yang YS, Moon SJ, Kwak SH, Jung HS, Park KS, Cho YM. Efficacy and Safety of Self-Titration Algorithms of Insulin Glargine 300 units/mL in Individuals with Uncontrolled Type 2 Diabetes Mellitus (The Korean TITRATION Study): A Randomized Controlled Trial. Diabetes Metab J. 2022 Jan;46(1):71-80. doi: 10.4093/dmj.2020.0274. Epub 2021 Jun 16.