Status:
UNKNOWN
Therapeutic Effects and Effects on Body Fat of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes for 1-4 Years
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Diabetes
Eligibility:
All Genders
Phase:
NA
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...
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05990374
Start Date
August 1 2023
End Date
January 1 2024
Last Update
August 14 2023
Active Locations (1)
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1
Nanjing First Hospital, Nanjing Medical Univesity
Nanjing, China