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

NCT ID: NCT05990374

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dulaglutide

Once a week, subcutaneous injection

Group Type ACTIVE_COMPARATOR

Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc

Intervention Type DRUG

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

semaglutide

Once a week, subcutaneous injection

Group Type ACTIVE_COMPARATOR

Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc

Intervention Type DRUG

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

Loseenatide

Once a week, subcutaneous injection

Group Type ACTIVE_COMPARATOR

Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc

Intervention Type DRUG

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

tirzepatide

Once a week, subcutaneous injection

Group Type ACTIVE_COMPARATOR

Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc

Intervention Type DRUG

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

elbenatide

Once a week, subcutaneous injection

Group Type ACTIVE_COMPARATOR

Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc

Intervention Type DRUG

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

original treatment

Once a week, subcutaneous injection

Group Type ACTIVE_COMPARATOR

Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc

Intervention Type DRUG

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

placebo

The patients will be treated according to the original protocol

Group Type PLACEBO_COMPARATOR

Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nanjing First Hospital, Nanjing Medical Univesity

Nanjing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bingli Liu

Role: CONTACT

+86 15366110069

Facility Contacts

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Jianhua Ma, Professor

Role: primary

References

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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.

Reference Type DERIVED
PMID: 40607222 (View on PubMed)

Other Identifiers

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KY20220825-04

Identifier Type: -

Identifier Source: org_study_id

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