Efficacy and Safety Of Different Hypoglycemic Regimens Compared With Premixed Insulin In Patients With Type 2 Diabetes Receiving Short-term Intensive Insulin Therapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in HbA1c
研究概览
简要总结
The purpose of this studay is to compare the efficacy of different hypoglycemic regimens versus twice-daily premixed insulin in type 2 diabetes mellitus (T2DM) patients after short-term ntensive Insulin Therapy by using continuous glucose monitoring.
详细描述
This randomized, positive-controlled, open-label, parallel-group study will enroll approximately 78 male and female patients aged 18-70 years with poorly-controlled T2DM (HbA1c >9% or FBS>11.1mmol/L) after short-term intensive insulin therapy. Eligible patients will then be randomized in a 1:1:1 ratio to insulin glargine plus OADs or twice-daily premixed insulin or Insulin Degludec & Liraglutide for 3 months with metformin maintained throughout the study in both treatment groups. All the patients will wear CGM during short-term intensive insulin therapy and after treatment for 7 days. The primary endpoint is plasma glucose change from baseline to month 3. Secondary endpoints include assessment of fasting plasma glucose, total daily insulin dose, hypoglycemia incidence, body weight change, adverse events, and patient satisfaction.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-70 years with poorly-controlled T2DM (World Health Organization diagnostic criteria)
- •BMI 21~32Kg/m2
- •duration of T2DM more than 1 year
- •FPG≥11.1mmol/L or HbA1c ≥9% for three months
- •fasting C-peptide >1 ng/mL
排除标准
- •acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic diabetic coma) within the past 1 month;
- •impaired renal function,defined as (but not limited to) serum creatinine levels ≥1.5 mg/dL for males and ≥1.4 mg/dL for females, or the presence of macroproteinuria (> 2 g/day)
- •pregnancy
- •inability to perform self-monitoring of BG (SMBG)
- •acute disease or surgery in the past 3months or preparation for the surgey
研究组 & 干预措施
metformin+empagliflozin+insulin glargine
metformin+empagliflozin+insulin glargine
干预措施: metformin+empagliflozin+insulin glargine (Drug)
IDegLira
IDegLira
干预措施: IDegLira (Drug)
premixed insulin analogues
premixed insulin analogues
干预措施: premixed insulin analogues (Drug)
结局指标
主要结局
Mean Change From Baseline in HbA1c
时间窗: Month 0 to 3
mean change from baseline in HbA1c after 3-months of treatment.
Percentage of patients achieving HbA1c <7%
时间窗: Month 0 to 3
Percentage of patients achieving HbA1c \<7% after 3-months of treatment.
Amplitude of glycemic excursions
时间窗: Month 0 to 3
Amplitude of glycemic excursions from month 0 to 3
次要结局
- Percentage of hypoglycemia incidence(Month 0 to 3)
- Percentage of adverse events(Month 0 to 3)