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

Central South University

Status and phase: Enrolling; Phase 4

Conditions: Overweight or Obesity; Diabetes Mellitus, Type 2

Treatments: Drug: Dulaglutide; Drug: Beinaglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT05005741

BENEFIT 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Beinaglutide

Experimental group

Treatment:

Drug: Beinaglutide

Dulaglutide

Active Comparator group

Treatment:

Drug: Dulaglutide