Clinical trial NCT05005741: The Effects of Glucose Control and Weight Loss Between Beinaglutide and Dulaglutide in Type 2 Diabetes With Overweight or Obesity.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Overweight or Obesity
Keywords: GLP-1 receptor agonist
Beinaglutide
Dulaglutide
Type 2 diabetes
HbA1c
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
name: First Affiliated Hospital of Harbin Medical University
name: The First Affiliated Hospital of Henan University of Science and Technology
First posted: 2021-08-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: haemoglobin A1c(HbA1c)
timeFrame: From baseline to 16 week.
Secondary outcomes:
measure: Weight loss
timeFrame: From baseline to 16 week.
measure: GLucose
timeFrame: From baseline to 16 week.
measure: Body Mass Index(BMI)
timeFrame: From baseline to 16 week.
measure: Waistline
timeFrame: From baseline to 16 week.
measure: Hipline
timeFrame: From baseline to 16 week.
measure: Serum total cholesterol
timeFrame: From baseline to 16 week.
measure: Serum triglycerides
timeFrame: From baseline to 16 week.
measure: Serum Low Density Lipoprotein-Cholesterol(LDL-C)
timeFrame: From baseline to 16 week.
measure: Serum High Density Lipoprotein-Cholesterol(HDL-C)
timeFrame: From baseline to 16 week.
measure: Adipose tissue of liver
timeFrame: From baseline to 16 week.
measure: Homeostasis model assessment for insulin resistance(HOMA-IR)
timeFrame: From baseline to 16 week.
measure: Homeostasis model assessment for β cell(HOMA-β)
timeFrame: From baseline to 16 week.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Ha'erbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
References: