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.
Status
Unknown
Phase
Phase 4
Enrollment
120
Locations
4
Results
Not posted
Publications
0
Study 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.
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.
Interventions
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.
DRUG
Patients received 1.5mg Dulaglutide subcutaneously once-weekly for 16 weeks.
Timeline
First posted
Aug 13, 2021
Study start
May 1, 2021
Primary completion
Dec 31, 2023
Study completion
Dec 31, 2023
Results posted
Not reported
Registry updated
Mar 17, 2023
Outcomes
haemoglobin A1c(HbA1c)
Time frame · From baseline to 16 week.
Absolute changes from baseline in HbA1c at week 16.
Weight loss
Time frame · From baseline to 16 week.
The proportion of weight loss from baseline to week 16;the proportion of subjects who loss 5% weight at week 16 compares baseline.
GLucose
Time frame · From baseline to 16 week.
Absolute changes from baseline in fasting glucose and postprandial glucose at week 16.
Body Mass Index(BMI)
Time frame · From baseline to 16 week.
Absolute changes from baseline in BMI in at week 16, body mass index (BMI) was calculated as the body weight (kg)/height (m)2.
Waistline
Time frame · From baseline to 16 week.
Absolute changes from baseline in waistline at week 16.
Hipline
Time frame · From baseline to 16 week.
Absolute changes from baseline in hipline at week 16.
Serum total cholesterol
Time frame · From baseline to 16 week.
Absolute changes from baseline in serum total cholesterol at week 16.
Serum triglycerides
Time frame · From baseline to 16 week.
Absolute changes from baseline in triglycerides at week 16.
Serum Low Density Lipoprotein-Cholesterol(LDL-C)
Time frame · From baseline to 16 week.
Absolute changes from baseline in LDL-C at week 16.
Serum High Density Lipoprotein-Cholesterol(HDL-C)
Time frame · From baseline to 16 week.
Absolute changes from baseline in HDL-C at week 16.
Adipose tissue of liver
Time frame · From baseline to 16 week.
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.
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.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Publications
No PMID-linked publications were present in this registry snapshot.
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