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

August 6, 2023 updated by: Nanjing First Hospital, Nanjing Medical University
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effects of different GLP-1 on blood glucose
Time Frame: 1,2,3,4 year
The changes of blood glucose fluctuation after treatment
1,2,3,4 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effects of different GLP-1 on body fat mass
Time Frame: 1,2,3,4 year
The changes of body fat mass after treatment
1,2,3,4 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing First Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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