DiabetesNCT05990374
Therapeutic Effects and Effects on Body Fat of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes for 1-4 Years
A study testing Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc in people with Diabetes, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes
- What is being tested?
- Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital, Nanjing Medical Univesity
Nanjing
Jianhua Ma, Professor
About this study
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etcDrug
The study compared patients taking different types of GLP-1(Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc) with taking placebo.
| Study group | Role | What they receive |
|---|---|---|
| Dulaglutide | Active comparator | Once a week, subcutaneous injection Receives: Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc |
| semaglutide | Active comparator | Once a week, subcutaneous injection Receives: Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc |
| Loseenatide | Active comparator | Once a week, subcutaneous injection Receives: Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc |
| tirzepatide | Active comparator | Once a week, subcutaneous injection Receives: Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc |
| elbenatide | Active comparator | Once a week, subcutaneous injection Receives: Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc |
| original treatment | Active comparator | Once a week, subcutaneous injection Receives: Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc |
| placebo | Placebo comparator | The patients will be treated according to the original protocol Receives: Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of different GLP-1 on blood glucose
The changes of blood glucose fluctuation after treatment
Measured: 1,2,3,4 year
Secondary outcomes (1)
Effects of different GLP-1 on body fat mass
The changes of body fat mass after treatment
Measured: 1,2,3,4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990374
- Sponsor's protocol ID
- KY20220825-04
- Status last verified
- Jun 2023
- First submitted
- 6 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40607222
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects and Effects on Body Fat of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes for 1-4 Years
- ClinicalTrials.gov ID
- NCT05990374
- Acronym / sponsor ID
- KY20220825-04
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Dulaglutide | Active comparator | Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etcOnce a week, subcutaneous injection |
| semaglutide | Active comparator | Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etcOnce a week, subcutaneous injection |
| Loseenatide | Active comparator | Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etcOnce a week, subcutaneous injection |
| tirzepatide | Active comparator | Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etcOnce a week, subcutaneous injection |
| elbenatide | Active comparator | Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etcOnce a week, subcutaneous injection |
| original treatment | Active comparator | Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etcOnce a week, subcutaneous injection |
| placebo | Placebo comparator | Drug: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etcThe patients will be treated according to the original protocol |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etcThe study compared patients taking different types of GLP-1(Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc) with taking placebo. | Drug | Dulaglutide, Loseenatide, elbenatide, original treatment, placebo, semaglutide, tirzepatide |
Primary outcome
Effects of different GLP-1 on blood glucose
Time frame: 1,2,3,4 year
The changes of blood glucose fluctuation after treatment
1 secondary outcome
Effects of different GLP-1 on body fat mass
Time frame: 1,2,3,4 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 40607222Xu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc in people with Diabetes, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bingli Liu (+86 15366110069, lxmxjtu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of different GLP-1 on blood glucose (time frame: 1,2,3,4 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05990374, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.