Logo 1 Logo 2

Clinical Trial Details

Trial ID: L4250
Source ID: NCT05005741
Associated Drug: Beinaglutide
Title: The Effects of Glucose Control and Weight Loss Between Beinaglutide and Dulaglutide in Type 2 Diabetes With Overweight or Obesity.
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Overweight or Obesity
Interventions: DRUG: Beinaglutide|DRUG: Dulaglutide
Outcome Measures: Primary: haemoglobin A1c(HbA1c), Absolute changes from baseline in HbA1c at week 16., From baseline to 16 week. | Secondary: 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.
Sponsor/Collaborators: 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
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 120
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-05-01
Completion Date: 2023-12-31
Results First Posted:
Last Update Posted: 2023-03-17
Locations: Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China|The First Affiliated Hospital of Harbin Medical University, Ha'erbin, Heilongjiang, China|The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, China|The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China
URL: https://clinicaltrials.gov/show/NCT05005741