Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes Insufficiently Controlled by Insulin Glargine and Metformin Combination Therapy
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in glycated hemoglobin (HbA1c)
研究概览
简要总结
The investigators aimed to compare efficacy and safety of IGlarLixi and insulin glargine plus dulaglutide as intensification from basal insulin with metformin, in the absence of head-to-head trials.
详细描述
Fixed-dose combinations of insulin glargine/lixisenatide (IGlarLixi) or insulin glargine plus dulaglutide constitute treatment intensification in type 2 diabetes mellitus (T2D). The investigators aimed to compare efficacy and safety of IGlarLixi and insulin glargine plus dulaglutide as intensification from basal insulin with metformin, in the absence of head-to-head trials. Treatments were compared in terms of glycated hemoglobin (HbA1c), fasting plasma glucose (FPG) change from baseline, and variables from continuous glucose monitoring (CGM) system; in addition to safety issues on hypoglycemia and changes in weight.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Patient with type 2 diabetes, treated with basal insulin plus metformin (maximum tolerated dosage) for at least 12 weeks
- •Patient accepting to participant to this study
排除标准
- •Pregnant or breastfeeding woman
- •severe renal dysfunction (eGFR <60 ml/min/1.73m2)
- •chronic or acute hepatic disorder (HBV or HCV hepatitis, liver cirrhosis etc.) (AST/ALT > 2.5*ULN)
- •Prescription such as immunosuppressant agents, glucocorticoids
- •Active anti-cancer treatment
研究组 & 干预措施
iGlar/Lixi
Switching to IGlarLixi from insulin glargine iGlar/Lixi starts with the following doses depending on the existing insulin glargine dose: 1) insulin glargine <20 unit/day = iGlar/Lixi 10 unit/day, 2) insulin glargine >=20 unit/day = iGlar/Lixi 20 unit/day.
Training to increase the iGlar/Lixi dosage every 3 days to meet the target fasting blood glucose level to 80~130 mg/day
干预措施: IGlarLixi (Drug)
Dulaglutide plus insulin glargine
Adding Dulaglutide to insulin glargine. Keep insulin glargine and dulaglutide start at 0.75 mg per week and increase to 1.5 mg per week after 1 month with evaluating compliance and tolerability.
干预措施: Dulaglutide (Drug)
结局指标
主要结局
Changes in glycated hemoglobin (HbA1c)
时间窗: Baseline, week 12
HbA1c will be measured at baseline and week 12
次要结局
- Changes in glucose time in range (TIR)(Baseline, week 12)
- Changes in glucose time below range (TBR)(Baseline, week 12)
- Changes in fasting plasma glucose (FPG)(Baseline, week 12)
- Incidence of hypoglycemia(Baseline, week 12)
- Changes in weight(Baseline, week 12)
- Changes in glucose time above range (TAR)(Baseline, week 12)
研究者
Eu Jeong Ku
Clinical Associate Professor
Chungbuk National University Hospital