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

Last updated: March 15, 2023
Sponsor: Second Xiangya Hospital of Central South University
Overall Status: Active - Recruiting

Phase

4

Condition

Weight Loss

Diabetes Prevention

Obesity

Treatment

N/A

Clinical Study ID

NCT05005741
BENEFIT 1
  • Ages 18-70
  • All Genders

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.

Eligibility Criteria

Inclusion

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

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 ofscreening;
  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 6months of screening;
  7. Alanine aminotransferase or aspartate transaminase more than 3 times of the normalupper 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 Design

Total Participants: 120
Study Start date:
May 01, 2021
Estimated Completion Date:
December 31, 2023

Study 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.

Connect with a study center

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • The First Affiliated Hospital of Harbin Medical University

    Ha'erbin, Heilongjiang
    China

    Active - Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan
    China

    Active - Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Active - Recruiting

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