Last updated: August 6, 2023
Sponsor: Nanjing First Hospital, Nanjing Medical University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Diabetic Gastroparesis
Diabetic Vitreous Hemorrhage
Diabetic Neuropathy
Treatment
Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc
Clinical Study ID
NCT05990374
KY20220825-04
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosed type 2 diabetes according to the 1999 WHO standards;
- received at least 8 weeks of simple diet control and physical exercise beforescreening; Patients with type 2 diabetes who were treated with stable hypoglycemicdrugs 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
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 incretinanalogue;
- Long-term (more than 7 consecutive days) intravenous administration, oraladministration, or intra-articular administration of corticosteroids within 2 monthsprior to screening;
- Use of weight control drugs or surgery that can lead to weight instability within 2months before screening, or are currently in a weight loss program and not in themaintenance 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 priorto screening;
- had received coronary angioplasty, coronary stenting, or coronary artery bypass within 6 months before screening. Negligent compensatory heart failure (NYHA rating III andIV), 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.
Study Design
Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc
Phase:
Study Start date:
August 01, 2023
Estimated Completion Date:
January 01, 2024
Study Description
Connect with a study center
Nanjing First Hospital, Nanjing Medical Univesity
Nanjing,
ChinaActive - Recruiting

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