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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05005741
• Other study ID #: BENEFIT 1
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Second Xiangya Hospital of Central South University
• Contact: Zhiguang Zhou, MD/PhD
• Phone: 86-731-85292154
• Email: zhouzg[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Overweight
• Overweight or Obesity
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital of Harbin Medical University	Ha'erbin	Heilongjiang
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan

Sponsors (4)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University	First Affiliated Hospital of Harbin Medical University, Guangdong Provincial People's Hospital, The First Affiliated Hospital of Henan University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	haemoglobin A1c(HbA1c)	Absolute changes from baseline in HbA1c at week 16.	From baseline to 16 week.
Secondary	Weight loss	The proportion of weight loss from baseline to week 16;the proportion of subjects who loss 5% weight at week 16 compares baseline.	From baseline to 16 week.
Secondary	GLucose	Absolute changes from baseline in fasting glucose and postprandial glucose at week 16.	From baseline to 16 week.
Secondary	Body Mass Index(BMI)	Absolute changes from baseline in BMI in at week 16, body mass index (BMI) was calculated as the body weight (kg)/height (m)2.	From baseline to 16 week.
Secondary	Waistline	Absolute changes from baseline in waistline at week 16.	From baseline to 16 week.
Secondary	Hipline	Absolute changes from baseline in hipline at week 16.	From baseline to 16 week.
Secondary	Serum total cholesterol	Absolute changes from baseline in serum total cholesterol at week 16.	From baseline to 16 week.
Secondary	Serum triglycerides	Absolute changes from baseline in triglycerides at week 16.	From baseline to 16 week.
Secondary	Serum Low Density Lipoprotein-Cholesterol(LDL-C)	Absolute changes from baseline in LDL-C at week 16.	From baseline to 16 week.
Secondary	Serum High Density Lipoprotein-Cholesterol(HDL-C)	Absolute changes from baseline in HDL-C at week 16.	From baseline to 16 week.
Secondary	Adipose tissue of liver	Absolute changes from baseline in HDL-C at week 16, adipose tissue of liver will be mersured by Fibroscan, a device useing an ultrasound transducer probe to vibrations of liver presenting adipose tissue content.	From baseline to 16 week.
Secondary	Homeostasis model assessment for insulin resistance(HOMA-IR)	Absolute changes from baseline in HOMA-IR at week 16, HOMA-IR was calculated as [fasting glucose (mmol/L)× fasting insulin (µU/ml)/22.5].	From baseline to 16 week.
Secondary	Homeostasis model assessment for ß cell(HOMA-ß)	Absolute changes from baseline in HOMA-ß at week 16, HOMA-ß was calculated as [20× fasting insulin (µU/ml)/fasting glucose (mmol/L)-3.5].	From baseline to 16 week.