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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving fasting SMPG ≤ 5.6 mmol/L without hypoglycemia at 12 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
- ≥ 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
干预措施: Group 1 (Behavioral)
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
- ≥ 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
干预措施: Group 2 (Behavioral)
结局指标
主要结局
Proportion of patients achieving fasting SMPG ≤ 5.6 mmol/L without hypoglycemia at 12 weeks
时间窗: up to 12 weeks
次要结局
- Proportion of patients at HbA1c ≤ 7%(up to 12 weeks)
- Hypoglycemia (number of patients)(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)
- 7-point SMPG (mmol/L)(up to 12 weeks)
- Changes in HbA1c (%)(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)
研究者
Young Min Cho
Professor
Seoul National University Hospital