Therapeutic Effects and Effects on Body Fat of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes for 1-4 Years

Study Overview
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Brief Summary
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The efficacy of long-term treatment with different GLP-1RA (Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc.) was evaluated through 1-4 years of follow-up, and the effects of long-term treatment on blood glucose and body fat of patients.

Detailed Description
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At present, there has been no evaluation on the efficacy of long-term treatment of different GLP-1RA (Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc.), and the effects of long-term treatment on patients' blood glucose and body fat. This study intends to follow up for 1-4 years. To observe the effects of different GLP-1RA on body fat, insulin resistance, body weight, blood glucose, blood lipids, stomach volume, etc., in patients with type 2 diabetes, and explore the factors affecting the efficacy, so as to provide more evidence-based medical evidence for drug treatment and benefit patients.

Official Title
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Therapeutic Effects and Effects on Body Fat of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes for 1-4 Years

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed type 2 diabetes according to the 1999 WHO standards; received at least 8 weeks of simple diet control and physical exercise before screening; Patients with type 2 diabetes who were treated with stable hypoglycemic drugs and had inadequate glycemic control within 8 weeks prior to screening; HbA1c≥7.5%； BMI>24kg/m2; Subjects agree to maintain a scientific diet and exercise habits throughout the study, and regularly self-monitor and record blood sugar (SMBG); Be willing to sign written informed consent and comply with the study protocol Exclusion Criteria: Use of any of the following drugs or treatments in the 3 months prior to screening: treatment with GLP-1RA, GLP-1 analogue, DPP-4 inhibitor, or any other incretin analogue; Long-term (more than 7 consecutive days) intravenous administration, oral administration, or intra-articular administration of corticosteroids within 2 months prior to screening; Use of weight control drugs or surgery that can lead to weight instability within 2 months before screening, or are currently in a weight loss program and not in the maintenance stage: History of acute and chronic pancreatitis; A history of medullary C-cell carcinoma, MEN (multiple endocrine tumors) 2A or 2B syndrome, or related family history; Clinically significant gastric emptying abnormalities; tumors of any organ system that have been treated or not treated in the 5 years prior to screening; had received coronary angioplasty, coronary stenting, or coronary artery bypass within 6 months before screening. Negligent compensatory heart failure (NYHA rating III and IV), stroke or transient ischemic attack, unstable angina, myocardial infarction, persistent and clinically significant arrhythmia; Acute metabolic complications occurred within 6 months before screening; Before screening, any of the laboratory test indicators meet the following criteria: glutamic-pyrugenic transaminase >2.5 times or ASpartate transaminase >2.5 times; eGFR <45ml/min/1.73m2; Fasting glycerin tricol >5.64mmol/L.
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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dulaglutide<br>Once a week, subcutaneous injection | Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc<br>* The study compared patients taking different types of GLP-1(Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc) with taking placebo.<br>|
| Active Comparator: semaglutide<br>Once a week, subcutaneous injection | Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc<br>* The study compared patients taking different types of GLP-1(Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc) with taking placebo.<br>|
| Active Comparator: Loseenatide<br>Once a week, subcutaneous injection | Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc<br>* The study compared patients taking different types of GLP-1(Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc) with taking placebo.<br>|
| Active Comparator: tirzepatide<br>Once a week, subcutaneous injection | Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc<br>* The study compared patients taking different types of GLP-1(Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc) with taking placebo.<br>|
| Active Comparator: elbenatide<br>Once a week, subcutaneous injection | Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc<br>* The study compared patients taking different types of GLP-1(Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc) with taking placebo.<br>|
| Active Comparator: original treatment<br>Once a week, subcutaneous injection | Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc<br>* The study compared patients taking different types of GLP-1(Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc) with taking placebo.<br>|
| Placebo Comparator: placebo<br>The patients will be treated according to the original protocol | Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc<br>* The study compared patients taking different types of GLP-1(Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc) with taking placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of different GLP-1 on blood glucose | The changes of blood glucose fluctuation after treatment | 1,2,3,4 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of different GLP-1 on body fat mass | The changes of body fat mass after treatment | 1,2,3,4 year |