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

Primary Purpose

Diabetes Mellitus, Type 2, Overweight or Obesity

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Beinaglutide
Dulaglutide
Sponsored by
Second Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring GLP-1 receptor agonist, Beinaglutide, Dulaglutide, Type 2 diabetes, HbA1c

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guangdong Provincial People's HospitalRecruiting
  • The First Affiliated Hospital of Harbin Medical UniversityRecruiting
  • The First Affiliated Hospital of Henan University of Science and TechnologyRecruiting
  • The Second Xiangya Hospital of Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Beinaglutide

Dulaglutide

Arm Description

Outcomes

Primary Outcome Measures

haemoglobin A1c(HbA1c)
Absolute changes from baseline in HbA1c at week 16.

Secondary Outcome Measures

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.
GLucose
Absolute changes from baseline in fasting glucose and postprandial glucose at week 16.
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.
Waistline
Absolute changes from baseline in waistline at week 16.
Hipline
Absolute changes from baseline in hipline at week 16.
Serum total cholesterol
Absolute changes from baseline in serum total cholesterol at week 16.
Serum triglycerides
Absolute changes from baseline in triglycerides at week 16.
Serum Low Density Lipoprotein-Cholesterol(LDL-C)
Absolute changes from baseline in LDL-C at week 16.
Serum High Density Lipoprotein-Cholesterol(HDL-C)
Absolute changes from baseline in HDL-C at week 16.
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.
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].
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].

Full Information

First Posted
August 9, 2021
Last Updated
March 15, 2023
Sponsor
Second Xiangya Hospital of Central South University
Collaborators
Guangdong Provincial People's Hospital, First Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Henan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05005741
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Xiangya Hospital of Central South University
Collaborators
Guangdong Provincial People's Hospital, First Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Henan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Overweight or Obesity
Keywords
GLP-1 receptor agonist, Beinaglutide, Dulaglutide, Type 2 diabetes, HbA1c

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Beinaglutide
Arm Type
Experimental
Arm Title
Dulaglutide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Beinaglutide
Other Intervention Name(s)
GLP-1 receptor agonist
Intervention Description
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
Intervention Name(s)
Dulaglutide
Other Intervention Name(s)
Trulicity, GLP-1 receptor agonist
Intervention Description
Patients received 1.5mg Dulaglutide subcutaneously once-weekly for 16 weeks.
Primary Outcome Measure Information:
Title
haemoglobin A1c(HbA1c)
Description
Absolute changes from baseline in HbA1c at week 16.
Time Frame
From baseline to 16 week.
Secondary Outcome Measure Information:
Title
Weight loss
Description
The proportion of weight loss from baseline to week 16；the proportion of subjects who loss 5% weight at week 16 compares baseline.
Time Frame
From baseline to 16 week.
Title
GLucose
Description
Absolute changes from baseline in fasting glucose and postprandial glucose at week 16.
Time Frame
From baseline to 16 week.
Title
Body Mass Index(BMI)
Description
Absolute changes from baseline in BMI in at week 16, body mass index (BMI) was calculated as the body weight (kg)/height (m)2.
Time Frame
From baseline to 16 week.
Title
Waistline
Description
Absolute changes from baseline in waistline at week 16.
Time Frame
From baseline to 16 week.
Title
Hipline
Description
Absolute changes from baseline in hipline at week 16.
Time Frame
From baseline to 16 week.
Title
Serum total cholesterol
Description
Absolute changes from baseline in serum total cholesterol at week 16.
Time Frame
From baseline to 16 week.
Title
Serum triglycerides
Description
Absolute changes from baseline in triglycerides at week 16.
Time Frame
From baseline to 16 week.
Title
Serum Low Density Lipoprotein-Cholesterol(LDL-C)
Description
Absolute changes from baseline in LDL-C at week 16.
Time Frame
From baseline to 16 week.
Title
Serum High Density Lipoprotein-Cholesterol(HDL-C)
Description
Absolute changes from baseline in HDL-C at week 16.
Time Frame
From baseline to 16 week.
Title
Adipose tissue of liver
Description
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.
Time Frame
From baseline to 16 week.
Title
Homeostasis model assessment for insulin resistance(HOMA-IR)
Description
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].
Time Frame
From baseline to 16 week.
Title
Homeostasis model assessment for β cell(HOMA-β)
Description
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].
Time Frame
From baseline to 16 week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 to 70 years old from all sex; Diagnosed with type 2 diabetes and HbA1c between 7% to 10%; BMI from 24 to 35kg/m² or waistline longger than 90cm（male）/85cm（female）; Volunteer to participate in the study with informed consent; Exclusion Criteria: Type 1 diabetes or other specific types of diabetes; Taking drugs of GLP-1 receptor agonist、TZDs and SGLT2 inhibitor within 3 months of screening; Taking insulin or insulin analogues more than 7 days within 3 months of screening; Pregnancy, breastfeeding or planned pregnancy; History of acute or chronic pancreatitis; Taking glucocorticoids(oral or intravenous) continuously more than 7 days within 6 months of screening; 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; renal impairment (estimated glomerular filtration rate<60mL/min per 1.73 m²); History of gastrointestinal disease; History of malignant tumor within 5 years of screening; History of organ transplantation or AIDS; History of glaucoma; History of hyperthyroidism or hypothyroidism; History of medullary thyroid carcinoma or multiple endocrine neoplasia II; History of abnormal of Calcitonin or thyroid tumor; History of alcohol abuse; Recruited by other clinical trials within 3 months of screening; Taking drugs of weight loss within 3 months of screening; History of bariatric surgery; History of mental disorders; History of rheumatic diseases or autoimmune diseases; Allergic to beinaglutide or dulaglutide; Participants who estimated would not be suitable for the study by the investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiguang Zhou, MD/PhD
Phone
86-731-85292154
Email
zhouzg@hotmail.com
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Ha'erbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiguang Zhou, MD/PhD
Phone
86-731-85292154
Email
zhouzg@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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