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

Seoul National University

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: Group 1; Behavioral: Group 2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03406663

H-1708-078-878

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Group 1

Experimental group

Description:

In group 1, the dose of Gla-300 will be titrated by the patients by 1 unit per day until achieving a fasting SMPG in the target range of 4.4 to 5.6 mmol/L (INSIGHT algorithm). Titration algorithms: Patients will be instructed to daily adjust their dose of Gla-300 based on fasting SMPG values. Fasting SMPG will be measured daily by the patient before breakfast and any intake of antihyperglycemic agents. Fasting SMPG in the range of 1. ≥ 5.6 mmol/L, increase 1 unit of Gla-300 dose 2. \> 4.4 and ≤ 5.6 mmol/L, no change 3. \< 4.4 mmol/L, reduce 1 unit of Gla-300 dose

Treatment:

Behavioral: Group 1

Group 2

Active Comparator group

Description:

In group 2, the dose of Gla-300 will be titrated by the patients based on the SMPG values of the last 3 days at least weekly, but no more often than every 3 days to achieve a fasting SMPG in the target range of 4.4 to 5.6 mmol/L (EDITION algorithm). Fasting SMPG (median of the last 3 days including current day) in the range of 1. ≥ 7.8 mmol/L, increase 6 units of Gla-300 dose 2. \> 5.6 and \< 7.8 mmol/L, increase 3 units of Gla-300 dose 3. \> 4.4 and ≤ 5.6 mmol/L, no change 4. ≥ 3.3 and \< 4.4 mmol/L, reduce 3 units of Gla-300 dose 5. \< 3.3 mmol/L or occurrence of ≥ 2 symptomatic or 1 severe hypoglycemic episode in the preceding week, reduce 3 units of Gla-300 dose or at the discretion of the investigator

Treatment:

Behavioral: Group 2