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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Overweight or Obesity
• Intervention / Treatment: Drug: Beinaglutide; Drug: Dulaglutide

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong Provincial People's Hospital
  • Heilongjiang
    • Ha'erbin, Heilongjiang, China
      • Recruiting
      • The First Affiliated Hospital of Harbin Medical University
  • Henan
    • Luoyang, Henan, China
      • Recruiting
      • The First Affiliated Hospital of Henan University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410011
      • Recruiting
      • The Second Xiangya Hospital Of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Beinaglutide	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.; Other Names: GLP-1 receptor agonist
Active Comparator: Dulaglutide	Drug: Dulaglutide; Patients received 1.5mg Dulaglutide subcutaneously once-weekly for 16 weeks.; Other Names: GLP-1 receptor agonist; Trulicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
haemoglobin A1c(HbA1c)	Absolute changes from baseline in HbA1c at week 16.	From baseline to 16 week.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
GLucose	Absolute changes from baseline in fasting glucose and postprandial glucose at week 16.	From baseline to 16 week.
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.
Waistline	Absolute changes from baseline in waistline at week 16.	From baseline to 16 week.
Hipline	Absolute changes from baseline in hipline at week 16.	From baseline to 16 week.
Serum total cholesterol	Absolute changes from baseline in serum total cholesterol at week 16.	From baseline to 16 week.
Serum triglycerides	Absolute changes from baseline in triglycerides at week 16.	From baseline to 16 week.
Serum Low Density Lipoprotein-Cholesterol(LDL-C)	Absolute changes from baseline in LDL-C at week 16.	From baseline to 16 week.
Serum High Density Lipoprotein-Cholesterol(HDL-C)	Absolute changes from baseline in HDL-C at week 16.	From baseline to 16 week.
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.
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.
Homeostasis model assessment for β cell(HOMA-β)	Absolute changes from baseline in HOMA-β at week 16, HOMA-β was calculated as [20× fasting insulin (μU/ml)/fasting glucose (mmol/L)-3.5].	From baseline to 16 week.

Collaborators and Investigators

• Sponsor: Second Xiangya Hospital of Central South University
• Collaborators: Guangdong Provincial People's Hospital; The First Affiliated Hospital of Henan University of Science and Technology; First Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: HbA1c; Type 2 diabetes; Beinaglutide; GLP-1 receptor agonist; Dulaglutide
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes; Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity; Weight Loss; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Dulaglutide; Glucagon; Glucagon-Like Peptide 1
• Other Study ID Numbers: BENEFIT 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No