A Comparison of Exenatide and Insulin Glargine on Glycemic Variability in T2DM Patients Inadequately Controlled With Metformin Monotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Mean amplitude of glycemic excursions (MAGE) change from baseline by continuous glucose monitoring system (CGMS)
研究概览
简要总结
This is a 16-week, Single-center, Randomized, Open Label, Parallel Controlled Group Comparison of the Comprehensive Glycemic Control of Exenatide and Insulin Glargine on Type 2 Diabetes Patients Inadequately Controlled With Metformin Monotherapy.
详细描述
Screening will be made to select eligible patients, then 44 patients receiving a stable dose of metformin (≥1500 mg daily) will be randomized (1:1) to receive exenatide or insulin glargine for 16 weeks. Exenatide will be administered twice daily by subcutaneous injection 30- 60 minutes before breakfast and dinner; the dose was 5 μg twice-daily for the first 4 weeks of treatment and 10 μg thereafter. Insulin glargine will be administered once daily at bedtime by subcutaneous injection. The dose of insulin glargine will initiate at ≥8 IU once-daily, and titrate based on a dosing algorithm targeting fasting blood glucose (FPG)<6.1 mmol/L. Titration is only allowed in first 4 weeks. At the end of the study, data will be collected and analyzed.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Type2 diabetic patients had been on stable, maximum tolerated doses of metformin (≧1500mg/d, ≧8 weeks)
- •Male or female age ≧ 18 years and ≦70 years old
- •HbA1c ≧7.0 and ≦10%
- •BMI ≧ 24 kg/m2
排除标准
- •Known or suspected allergy to trial products or related products.
- •Impaired renal function defined as serum-creatinine ≥ 1.5 mg/dl (≥ 133 umol/l).
- •Acute or chronic disease which may cause tissue hypoxia such as respiratory failure or shock.
- •Abnormal liver function, alanine transaminase or aspartate aminotransferase ≥ 3 fold normal upper limit, Total bilirubin ≥ 2 normal upper limit, acute alcohol intoxication, alcoholism.
- •Subjects has a clinically significant, active (or over the past 12 months) cardiovascular history (including a history of myocardial infarction (MI), arrhythmias or conduction delays on ECG, unstable angina, or decompensated heart failure (New York Heart Association-class Ⅲ and Ⅳ).
- •Proliferative retinopathy or muscular oedema requiring acute treatment.
- •Pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to use adequate contraception (adequate contraceptive measures are sterilization, intrauterine device, oral contraceptives or barrier methods).
- •Treatment with systemic corticosteroids within the past two months prior to screening.
- •Type 1 diabetes mellitus.
- •Receipt of any investigational drug within 1 month prior to this trial.
研究组 & 干预措施
exenatide
5 μg BID for the first 4 weeks of treatment and 10 μg thereafter
干预措施: exenatide (Drug)
exenatide
5 μg BID for the first 4 weeks of treatment and 10 μg thereafter
干预措施: Insulin glargine (Drug)
Insulin glargine
≥8 IU QD, and titrate based on a dosing algorithm targeting FPG <6.1 mmol/L. Titration is only allowed in first 4 weeks.
干预措施: exenatide (Drug)
Insulin glargine
≥8 IU QD, and titrate based on a dosing algorithm targeting FPG <6.1 mmol/L. Titration is only allowed in first 4 weeks.
干预措施: Insulin glargine (Drug)
结局指标
主要结局
Mean amplitude of glycemic excursions (MAGE) change from baseline by continuous glucose monitoring system (CGMS)
时间窗: 1±3day；112±3d
次要结局
- Glycemic variability(1±3day；112±3d)
- Glucose control(-7±3d；112±3d；)
- oxidative stress markers(1±3d；28±3d；56±3d；84±3d；112±3d)
- inflammatory markers(1±3d；28±3d；56±3d；84±3d；112±3d)
- endothelial function(1±3d；28±3d；56±3d；84±3d；112±3d)
- beta-cell function and insulin resistance(1±3d；112±3d；)
- body composition(1±3d；112±3d)
研究者
Dalong Zhu
Chief physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School