A Randomized Controlled, Open-label, Multi-center Study With 16-week Beinaglutide or Dulaglutide Assessing Effects on Glucose Control and Weight Loss in Type 2 Diabetes With Overweight or Obesity.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- haemoglobin A1c(HbA1c)
研究概览
简要总结
This study is a multi-center, open label, randomized controlled trial that main purpose of this study is to evaluate the differences of glucose control and weight loss between Beinaglutide and Dulaglutide in type 2 diabetes with overweight or or Obesity.
详细描述
About 2/3 of patients with type 2 diabetes are overweight or obese in China, several studies had confirmed that overweight and obesity could cause type 2 diabetes. GLP-1 receptor agonist could control diabetes meanwhile loss the patient weight. This is a multi-center, openlabel, 1:1 randomized controlled trial to investigate the differences of glucose control and weight loss between two GLP-1 receptor agonist, Beinaglutide and Dulaglutide, in type 2 diabetes with overweight or Obesity. The study comprises the 0-2 weeks of screening period and the 16-week intervention period. 120 patients according to the inclusion/exclusion criteria would recruit from 4 sites in China, then the participant will be randomized to three times a day of subcutaneous beinaglutide(dose escalate to 0.2mg), or once-weekly of 1.5mg subcutaneous dulaglutide for 16-week. The primary endpoint is the change from baseline to week 16 in HbA1c. The second endpoint is the change from baseline to week 16 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 70 years old from all sex;
- •Diagnosed with type 2 diabetes and HbA1c between 7% to 10%;
- •BMI from 24 to 35kg/m² or waistline longger than 90cm（male）/85cm（female）;
- •Volunteer to participate in the study with informed consent;
排除标准
- •Type 1 diabetes or other specific types of diabetes;
- •Taking drugs of GLP-1 receptor agonist、TZDs and SGLT2 inhibitor within 3 months of screening;
- •Taking insulin or insulin analogues more than 7 days within 3 months of screening;
- •Pregnancy, breastfeeding or planned pregnancy;
- •History of acute or chronic pancreatitis;
- •Taking glucocorticoids(oral or intravenous) continuously more than 7 days within 6 months of screening;
- •Alanine aminotransferase or aspartate transaminase more than 3 times of the normal upper limit, total bilirubin more than 2 times of the normal upper limit;
- •renal impairment (estimated glomerular filtration rate<60mL/min per 1.73 m²);
- •History of gastrointestinal disease;
- •History of malignant tumor within 5 years of screening;
- •History of organ transplantation or AIDS;
- •History of glaucoma;
- •History of hyperthyroidism or hypothyroidism;
- •History of medullary thyroid carcinoma or multiple endocrine neoplasia II;
- •History of abnormal of Calcitonin or thyroid tumor;
- •History of alcohol abuse;
- •Recruited by other clinical trials within 3 months of screening;
- •Taking drugs of weight loss within 3 months of screening;
- •History of bariatric surgery;
- •History of mental disorders;
- •History of rheumatic diseases or autoimmune diseases;
- •Allergic to beinaglutide or dulaglutide;
- •Participants who estimated would not be suitable for the study by the investigators.
研究组 & 干预措施
Beinaglutide
干预措施: Beinaglutide (Drug)
Dulaglutide
干预措施: Dulaglutide (Drug)
结局指标
主要结局
haemoglobin A1c(HbA1c)
时间窗: From baseline to 16 week.
Absolute changes from baseline in HbA1c at week 16.
次要结局
- Adipose tissue of liver(From baseline to 16 week.)
- Weight loss(From baseline to 16 week.)
- GLucose(From baseline to 16 week.)
- Body Mass Index(BMI)(From baseline to 16 week.)
- Waistline(From baseline to 16 week.)
- Hipline(From baseline to 16 week.)
- Serum total cholesterol(From baseline to 16 week.)
- Serum triglycerides(From baseline to 16 week.)
- Serum Low Density Lipoprotein-Cholesterol(LDL-C)(From baseline to 16 week.)
- Serum High Density Lipoprotein-Cholesterol(HDL-C)(From baseline to 16 week.)
- Homeostasis model assessment for insulin resistance(HOMA-IR)(From baseline to 16 week.)
- Homeostasis model assessment for β cell(HOMA-β)(From baseline to 16 week.)
研究者
Zhiguang Zhou
Director of The National Clinical Research Center for Metabolic Diseases, and Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Endocrinology, The Second Xiangya Hospital of Central South University.
Second Xiangya Hospital of Central South University