The Korean TITRATION Study: Comparison of the Self-titration Methods for Glargine-300
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Behavioral: Group 2Behavioral: Group 1
- Registration Number
- NCT03406663
- Lead Sponsor
- Seoul National University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 Group 2 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 Group 1 Group 1 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
- Primary Outcome Measures
Name Time Method Proportion of patients achieving fasting SMPG ≤ 5.6 mmol/L without hypoglycemia at 12 weeks up to 12 weeks
- Secondary Outcome Measures
Name Time Method Health care professionals' satisfaction to the insulin titration methods (evaluated by prespecirfied questionnaire: health care provider treatment satisfaction questionnaire) up to 12 weeks 7-point SMPG (mmol/L) up to 12 weeks Changes in HbA1c (%) up to 12 weeks Proportion of patients at HbA1c ≤ 7% up to 12 weeks Hypoglycemia (number of patients) up to 12 weeks Patient satisfaction to the insulin titration method (evaluated by prespecified questionnaire: DTSQs) up to 12 weeks Fasting plasma glucose (mmol/L) up to 12 weeks Change in body weight (kilogram) up to 12 weeks Adverse events up to 12 weeks Fasting SMPG (mmol/L) up to 12 weeks Change in insulin dose (IU) up to 12 weeks
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of