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

NCT ID: NCT05005741

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-12-31

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.

Conditions

Diabetes Mellitus, Type 2; Overweight or Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Beinaglutide

Group Type: EXPERIMENTAL

Beinaglutide

Intervention Type: DRUG

Patients received beinaglutide subcutaneously three times a day for 16 weeks, the dose of beinaglutide escalate from 0.06mg to 0.2mg per 3-7 days according to subject's specific situation.

Dulaglutide

Group Type: ACTIVE_COMPARATOR

Dulaglutide

Intervention Type: DRUG

Patients received 1.5mg Dulaglutide subcutaneously once-weekly for 16 weeks.

Interventions

Beinaglutide

Patients received beinaglutide subcutaneously three times a day for 16 weeks, the dose of beinaglutide escalate from 0.06mg to 0.2mg per 3-7 days according to subject's specific situation.

Intervention Type: DRUG

Dulaglutide

Patients received 1.5mg Dulaglutide subcutaneously once-weekly for 16 weeks.

Intervention Type: DRUG

Other Intervention Names

GLP-1 receptor agonist; Trulicity; GLP-1 receptor agonist

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Henan University of Science and Technology

OTHER

Sponsor Role: collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

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.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status: RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Site Status: RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhiguang Zhou, MD/PhD

Role: CONTACT

zhouzg@hotmail.com

86-731-85292154

Facility Contacts

Zhiguang Zhou, MD/PhD

Role: primary

zhouzg@hotmail.com

86-731-85292154

Other Identifiers

BENEFIT 1

Identifier Type: -

Identifier Source: org_study_id