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

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

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.

Eligibility Criteria

Inclusion

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 beforescreening; Patients with type 2 diabetes who were treated with stable hypoglycemicdrugs 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

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 incretinanalogue;
  2. Long-term (more than 7 consecutive days) intravenous administration, oraladministration, or intra-articular administration of corticosteroids within 2 monthsprior to screening;
  3. 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:
  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 priorto screening;
  7. 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;
  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.

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

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.

Connect with a study center

  • Nanjing First Hospital, Nanjing Medical Univesity

    Nanjing,
    China

    Active - Recruiting

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