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.
Overview
- Phase
- Phase 4
- Intervention
- Beinaglutide
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Second Xiangya Hospital of Central South University
- Enrollment
- 120
- Locations
- 4
- Primary Endpoint
- haemoglobin A1c(HbA1c)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
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
Eligibility Criteria
Inclusion Criteria
- •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;
Exclusion Criteria
- •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;
Arms & Interventions
Beinaglutide
Intervention: Beinaglutide
Dulaglutide
Intervention: Dulaglutide
Outcomes
Primary Outcomes
haemoglobin A1c(HbA1c)
Time Frame: From baseline to 16 week.
Absolute changes from baseline in HbA1c at week 16.
Secondary Outcomes
- 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.)