A Randomized,Active-controlled,Open-label Clinical Trial to Evaluate the Effect of GLP-1 Receptor Agonist (Exenatide Injection) in Combination With Metformin Therapy Compared to Premixed Insulin (BIAsp30) in Combination With Metformin Therapy on Diabetes Remission in Subjects With Newly Diagnosed Type 2 Diabetes Who Are Overweight or Obese
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Rate of Inducing Diabetes Remission
研究概览
简要总结
The purpose of this study is to determine the effect of GLP-1 receptor agonist on inducing diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese
详细描述
Most of type 2 diabetes are characterized by being overweight or obese mainly caused by insulin resistance. GLP-1 receptor agonist has been proved to help to lose weight and improve insulin resistance. In this study, we suppose that GLP-1 receptor agonist has the effect of inducing diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese and has its advantages
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A signed and dated informed consent form obtained from the subject before any study related procedures take place.
- •Age ≥18 years to ≤65 years at Visit
- •The subject has a new diagnosis of type 2 diabetes without any treatment.
- •HbA1c ≥8.0% to ≤14.0% at Visit
- •BMI(Body Mass Index)≥24kg/m2 to ≤40kg/m2 at Visit 1.
排除标准
- •The subject has a history of type 1 diabetes or a secondary form of diabetes.
- •The subject has received an anti-diabetic drug before the screening visit.
- •Treatment with systemic steroids 2 months prior to screening
- •Treatment with anti-obesity drug 2 months prior to screening or any other treatment at the time of screening(i.e. surgery etc) leading to unstable body weight.
- •The subject has a history of acute or chronic pancreatitis
- •Any gastrointestinal diseases or surgeries that induce chronic malabsorption
- •Cancer and medical history of cancer(except basal cell skin cancer or squamous cell skin cancer).
- •The subject has a history of recurrent severe hypoglycaemia.
- •Cardiovascular disease,within the last 6months prior to screening,defined as: stroke;decompensated heart failure New York Heart Association(NYHA) class III or IV;Myocardial infarction;unstable angina pectoris;or coronary bypass graft or angioplasty.
- •Uncontrolled treated/untreated severe hypertension (systolic blood pressure ≥180 millimetre(mm) mercury(Hg) and/or diastolic blood pressure ≥100 millimetre(mm) mercury(Hg).
- •Impaired liver function,defined as alanine aminotransferase(ALT) or aspartate aminotransferase(AST) ≥2.5 times upper limit of normal.
- •Impaired renal function,defined as serum-creatinine ≥125umol/l for males and ≥110umol/l for females.
- •Females who are pregnant or breast-feeding, males and females of childbearing potential,who do not agree to prevent conception during the study.
- •Known or suspected abuse of alcohol,narcotics or illicit drugs.
研究组 & 干预措施
Exenatide and Metformin
Exenatide in Combination With Metformin
干预措施: Exenatide (Drug)
Exenatide and Metformin
Exenatide in Combination With Metformin
干预措施: Metformin (Drug)
BIAsp30 and Metformin
BIAsp30 in Combination With Metformin
干预措施: BIAsp30 (Drug)
BIAsp30 and Metformin
BIAsp30 in Combination With Metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Rate of Inducing Diabetes Remission
时间窗: At the end of 12-week treatment
Change of Rate of Maintaining Diabetes Remission
时间窗: 3,6,12,24,36 months after 12-week treatment
Time of Maintaining Diabetes Remission
时间窗: up to 36 months after 12-week treatment
次要结局
- Change of Weight(baseline and 0,3,6,12,24,36 months after 12-week treatment)
- Change of Waistline(baseline and 0,3,6,12,24,36 months after 12-week treatment)
- The Incidence of Diabetic Retinopathy(up to 36 months after 12-week treatment)
- Change of Insulin Resistance Index(baseline and 0,3,6,12,24,36 months after 12-week treatment)
- The Incidence of Hypoglycemia(During the 12-week treatment)
- The Incidence of Diabetic Nephropathy(up to 36 months after 12-week treatment)
- Change of Blood Pressure(Baseline and 0,3,6,12,24,36 months after 12-week treatment)
- Change of Heart Rate(baseline and 0,3,6,12,24,36 months after 12-week treatment)
- Change of Glycosylated Hemoglobin(baseline and 0,3,6,12,24,36 months after 12-week treatment)
- Change of Pancreatic Beta-cell Function(baseline and 0,3,6,12,24,36 months after 12-week treatment)
研究者
Guixia Wang
Director of Endocrinology Department
The First Hospital of Jilin University