Comparison of Exenatide, Insulin or Pioglitazone on Glycaemic Control and β-cell Function in Drug-naïve Type 2 Diabetic Patients: A Multicentre Randomized Parallel-group Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 416
- 试验地点
- 25
- 主要终点
- the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks
研究概览
简要总结
The purpose of this study is to investigate and evaluate the effects of different interventions (1. exenatide, 2. insulin, 3. thiazolidinedione) on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.
详细描述
One of the fundamental defects in type 2 diabetes mellitus is declining β-cell function. Exenatide targets multiple metabolic disturbances in type 2 diabetes and exerts direct effects on β-cell, which indicates that it may not only contribute to the glucose control but also delay disease progression. There are trials demonstrated efficacy, safety and tolerability of exenatide. However, no study has compared the effects of exenatide with other hypoglycemic therapies with β cell protective function in newly diagnosed and drug-naïve type 2 diabetic patients. This current study is thus designed to evaluate the effects of exenatide, insulin and pioglitazone on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly-diagnosed type 2 diabetic patients, drug naïve
- •age 30~70 years
- •HbA1c 7.0~10.0%
- •BMI 20~35 kg/m2, stable body weight (≤10% variation) for at least 3 months prior to screening
- •female patients of reproductive age should practice a reliable method of birth control throughout the study
排除标准
- •acute or severe chronic diabetic complications
- •congestive heart failure (NYHA grade Ⅲ~Ⅳ)
- •severe gastrointestinal disease
- •severe osteoporosis or history of pathological fracture,or use of bisphosphonates preparation
- •other severe intercurrent illness
- •serum aminotransferase (ALT and AST) level higher than 2 times of the upper normal limits and/or serum creatinie≥133µmol/L (1.5mg/dL)
- •tested positive for glutamic acid decarboxylase antibody
- •use of weight loss drugs, corticosteroids, drugs known to affect gastrointestinal motility, transplantation medications, or any investigational drug
- •history of pancreatitis
- •serum triglyceride ≥ 5.0 mmol/L
- •pregnancy
研究组 & 干预措施
pioglitazone
干预措施: Pioglitazone (Drug)
Exenatide
干预措施: exenatide injection (Drug)
Premixed insulin analog
干预措施: Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R (Drug)
结局指标
主要结局
the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks
时间窗: 48 weeks
次要结局
- Percentage of Patients Achieving HbA1c <7% and ≤ 6.5% and Effect of Different Interventions on Fasting and Postprandial Plasma Glucose Concentration, Blood Pressure, Lipid Profiles(48 weeks)
- β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio)(48 weeks)
- Safety and Tolerability in Different Groups(48 weeks)
研究者
Jianping Weng
professor, vice president, the third affiliated hospital of Sun Yat-sen University
Sun Yat-sen University