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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Diabetes Mellitus, Type 2, Overweight or Obesity

Intervention / Treatment
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* Drug: Beinaglutide
* Drug: Dulaglutide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beinaglutide<br> | Drug: Beinaglutide<br>* 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.<br>* Other names: GLP-1 receptor agonist;|
| Active Comparator: Dulaglutide<br> | Drug: Dulaglutide<br>* Patients received 1.5mg Dulaglutide subcutaneously once-weekly for 16 weeks.<br>* Other names: GLP-1 receptor agonist;|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GLP-1 receptor agonist, Beinaglutide, Dulaglutide, Type 2 diabetes, HbA1c