Diabetes
Conditions
Brief summary
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
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.
Interventions
DRUGDuragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc
The study compared patients taking different types of GLP-1(Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc) with taking placebo.
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Diagnosed type 2 diabetes according to the 1999 WHO standards; 2. 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; 3. HbA1c≥7.5%； 4. BMI\>24kg/m2; 5. Subjects agree to maintain a scientific diet and exercise habits throughout the study, and regularly self-monitor and record blood sugar (SMBG); 6. Be willing to sign written informed consent and comply with the study protocol
Exclusion criteria
1. 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; 2. Long-term (more than 7 consecutive days) intravenous administration, oral administration, or intra-articular administration of corticosteroids within 2 months prior to screening; 3. 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: 4. 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; 5. Clinically significant gastric emptying abnormalities; 6. tumors of any organ system that have been treated or not treated in the 5 years prior to screening; 7. 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; 8. Acute metabolic complications occurred within 6 months before screening; 9. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of different GLP-1 on blood glucose | 1,2,3,4 year | The changes of blood glucose fluctuation after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of different GLP-1 on body fat mass | 1,2,3,4 year | The changes of body fat mass after treatment |
Countries
China
Contacts
Primary ContactBingli Liu
Outcome results
None listed