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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes
• Intervention / Treatment: Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bingli Liu; Phone Number: +86 15366110069; Email: lxmxjtu@sina.com

Study Locations

• China
  • Nanjing, China
    • Recruiting
    • Nanjing First Hospital, Nanjing Medical Univesity
    • Contact: Jianhua Ma, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

7

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: August 6, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Tirzepatide
• Other Study ID Numbers: KY20220825-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No