The Effects of Glucose Control and Weight Loss Between Beinaglutide and Dulaglutide in Type 2 Diabetes With Overweight or Obesity.

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Xiangya Hospital of Central South University
• Collaborators: First Affiliated Hospital of Harbin Medical University; Guangdong Provincial People's Hospital; The First Affiliated Hospital of Henan University of Science and Technology
• Treatments: Dulaglutide; Glucagon; Glucagon-Like Peptide 1

Criteria

Inclusion Criteria:

1. Age between 18 to 70 years old from all sex;

2. Diagnosed with type 2 diabetes and HbA1c between 7% to 10%;

3. BMI from 24 to 35kg/m² or waistline longger than 90cm（male）/85cm（female）;

4. Volunteer to participate in the study with informed consent;

Exclusion Criteria:

1. Type 1 diabetes or other specific types of diabetes;

2. Taking drugs of GLP-1 receptor agonist、TZDs and SGLT2 inhibitor within 3 months of screening;

3. Taking insulin or insulin analogues more than 7 days within 3 months of screening;

4. Pregnancy, breastfeeding or planned pregnancy;

5. History of acute or chronic pancreatitis;

6. Taking glucocorticoids(oral or intravenous) continuously more than 7 days within 6 months of screening;

7. 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;

8. renal impairment (estimated glomerular filtration rate<60mL/min per 1.73 m²);

9. History of gastrointestinal disease;

10. History of malignant tumor within 5 years of screening;

11. History of organ transplantation or AIDS;

12. History of glaucoma;

13. History of hyperthyroidism or hypothyroidism;

14. History of medullary thyroid carcinoma or multiple endocrine neoplasia II;

15. History of abnormal of Calcitonin or thyroid tumor;

16. History of alcohol abuse;

17. Recruited by other clinical trials within 3 months of screening;

18. Taking drugs of weight loss within 3 months of screening;

19. History of bariatric surgery;

20. History of mental disorders;

21. History of rheumatic diseases or autoimmune diseases;

22. Allergic to beinaglutide or dulaglutide;

23. Participants who estimated would not be suitable for the study by the investigators.