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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Group 1
* Behavioral: Group 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>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 ≥ 5.6 mmol/L, increase 1 unit of Gla-300 dose > 4.4 and ≤ 5.6 mmol/L, no change < 4.4 mmol/L, reduce 1 unit of Gla-300 dose | Behavioral: Group 1<br>* 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 ≥ 5.6 mmol/L, increase 1 unit of Gla-300 dose, > 4.4 and ≤ 5.6 mmol/L, no change, < 4.4 mmol/L, reduce 1 unit of Gla-300 dose<br>* Other names: INSIGHT algorithm;|
| Active Comparator: Group 2<br>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 ≥ 7.8 mmol/L, increase 6 units of Gla-300 dose > 5.6 and < 7.8 mmol/L, increase 3 units of Gla-300 dose > 4.4 and ≤ 5.6 mmol/L, no change ≥ 3.3 and < 4.4 mmol/L, reduce 3 units of Gla-300 dose < 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 | Behavioral: Group 2<br>* Fasting SMPG (median of the last 3 days including current day) in the range of 7.8 mmol/L, increase 6 units of Gla-300 dose, > 5.6 and < 7.8 mmol/L, increase 3 units of Gla-300 dose, > 4.4 and ≤ 5.6 mmol/L, no change, 3.3 and < 4.4 mmol/L, reduce 3 units of Gla-300 dose, < 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<br>* Other names: EDITION algorithm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving fasting SMPG ≤ 5.6 mmol/L without hypoglycemia at 12 weeks |  | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HbA1c (%) |  | up to 12 weeks | 
| Fasting plasma glucose (mmol/L) |  | up to 12 weeks | 
| Fasting SMPG (mmol/L) |  | up to 12 weeks | 
| 7-point SMPG (mmol/L) |  | up to 12 weeks | 
| Proportion of patients at HbA1c ≤ 7% |  | up to 12 weeks | 
| Change in insulin dose (IU) |  | up to 12 weeks | 
| Change in body weight (kilogram) |  | up to 12 weeks | 
| Hypoglycemia (number of patients) |  | up to 12 weeks | 
| Adverse events |  | up to 12 weeks | 
| Patient satisfaction to the insulin titration method (evaluated by prespecified questionnaire: DTSQs) |  | up to 12 weeks | 
| Health care professionals' satisfaction to the insulin titration methods (evaluated by prespecirfied questionnaire: health care provider treatment satisfaction questionnaire) |  | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin