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/AClinical Study ID
NCT05005741
BENEFIT 1
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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 ofscreening;
- 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 6months of screening;
- Alanine aminotransferase or aspartate transaminase more than 3 times of the normalupper 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.
Study Design
Total Participants: 120
Study Start date:
May 01, 2021
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
ChinaActive - Recruiting
The First Affiliated Hospital of Harbin Medical University
Ha'erbin, Heilongjiang
ChinaActive - Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
ChinaActive - Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan 410011
ChinaActive - Recruiting
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