Simplification of Complex Insulin Regimens With Preserving Good Glycemic Control in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of participants reaching HbA1c<7% and HbA1c<6.5%
研究概览
简要总结
This study examines prospectively the safety and efficacy of switching from multiple daily insulin injections (MDI) to once daily IDegLira (insulin degludec and liraglutide fix ratio combination), a fixed-ratio combination of insulin degludec and liraglutide, in relatively well controlled (HbA1c<7.5%) subjects with type 2 diabetes using low total daily insulin dose (TDD).
详细描述
Type 2 diabetic patients suffering from severe hyperglycemia are often apply multiple daily insulin injections (MDI). If glucose toxicity resolves, the regimen may potentially be simplified, but there are no specific guidelines regarding this and a lot of patients are left on MDI.
The Investigators aimed to examine prospectively the safety and efficacy of switching from MDI to once daily IDegLira, a fixed-ratio combination of insulin degludec and liraglutide, in relatively well controlled (HbA1c<7.5%) subjects with type 2 diabetes using low total daily insulin dose (TDD).
The investigators hypothesize that in everyday clinical practice switching from low dose MDI to IDegLira in patients of different ages with well-controlled (or overcontrolled) type 2 diabetes is safe, may induce weight loss and result in similar or better glycemic control.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic (T2D) patients >18 years old
- •detectable random, non-fasting serum C-peptide levels
- •HbA1c=< 7.5%
- •treated with MDI (with stable daily doses of insulin at least for 90 days prior to baseline visit)
- •using relatively low total daily insulin dose (TDD), at baseline visit low TDD is defined as TDD<70 IU/day and TDD<0.6 IU/kg/day at the same time.
排除标准
- •Type 1 diabetes
- •treatment of T2D with any medication for diabetes other than insulin or metformin during 90 days before baseline visit
- •active cancer
- •anaemia (haemoglobin <100g/l)
- •acute or chronic kidney disease with an estimated glomerular filtration rate <30 mL/min/1.73 m2
结局指标
主要结局
Number of participants reaching HbA1c<7% and HbA1c<6.5%
时间窗: it is checked at baseline and at 3, 6, 9 and 12 months
HbA1c is measuerd by laboratory blood test
change in body weight from baseline to 3, 6, 9 and 12 months
时间窗: it is checked at baseline and at 3, 6, 9 and 12 months
body weight is measured at the diabetes ambulance
change in risk of hypoglycemia from baseline to 3, 6, 9 and 12 months
时间窗: it is checked at baseline and at 3, 6, 9 and 12 months
hypoglycemia risk is assessed by analysing the patients' diary
次要结局
未报告次要终点
研究者
Zoltán Taybani
Principal investigator
Bekes County Central Hospital