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

NCT05990374 | Unknown

• 1 other identifier: KY20220825-04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Effects of different GLP-1 on blood glucose

  The changes of blood glucose fluctuation after treatment

  1,2,3,4 year

Secondary Outcomes (1)

• Effects of different GLP-1 on body fat mass

  1,2,3,4 year

Study Arms (7)

Dulaglutide

ACTIVE COMPARATOR

Once a week, subcutaneous injection

Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc

semaglutide

ACTIVE COMPARATOR

Once a week, subcutaneous injection

Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc

Loseenatide

ACTIVE COMPARATOR

Once a week, subcutaneous injection

Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc

tirzepatide

ACTIVE COMPARATOR

Once a week, subcutaneous injection

Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc

elbenatide

ACTIVE COMPARATOR

Once a week, subcutaneous injection

Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc

original treatment

ACTIVE COMPARATOR

Once a week, subcutaneous injection

Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc

placebo

PLACEBO COMPARATOR

The patients will be treated according to the original protocol

Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc

Interventions

Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc DRUG

The study compared patients taking different types of GLP-1(Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc) with taking placebo.

Dulaglutide; Loseenatide; elbenatide; original treatment; placebo; semaglutide; tirzepatide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital, Nanjing Medical Univesity

Nanjing, China

RECRUITING

Related Publications (1)

• Xu CL, Kong XC, Liu XM, Xu XH, Liu BL, Ma JH. Effect of Ebenatide on glycemic metabolism and body fat in patients with type 2 diabetes mellitus. Front Endocrinol (Lausanne). 2025 Jun 18;16:1622526. doi: 10.3389/fendo.2025.1622526. eCollection 2025.

  PMID: 40607222 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

semaglutide; Tirzepatide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Central Study Contacts

Bingli Liu

CONTACT

+86 15366110069; lxmxjtu@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: August 14, 2023
• Study Start: August 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-06

Locations

CN (1)