Type 2 Diabetes MellitusNCT06256419
Association of Gene Polymorphism With Susceptibility to T2DM and the Therapeutic Responses to Exenatide in Chinese Patients With T2DM
A study testing GLP-1 receptor agonist and responders group and nonresponders group in people with Type 2 Diabetes Mellitus and Susceptibility, Genetic, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
This is a retrospective cohort study of patients with T2DM who were treated with exenatide twice daily as a part of their diabetes care for at least 12 months. The objective of this study is to investigate the influence of T2DM susceptibility gene polymorphisms (NOS1AP, KCNQ1, TCF7L2, WSF1, GLP-1R, etc.) on the… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Susceptibility, Genetic
- What is being tested?
- GLP-1 receptor agonist and responders group and nonresponders group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of T2DM
- a body mass index (BMI) of 20-35 kg/m2
- an HbA1c of 7.0%-12%, an age of 25-70 years
- required data available at baseline and 6 months after GLP-1RA therapy.
Who cannot join
- Patients with serious diseases such as acute myocardial infarction, cerebral vascular accident, trauma, kidney or liver diseases, severe gastrointestinal dysfunction, and history of pancreatitis
- patients receiving GLP-1 analogues, weight loss drugs, glucocorticoids, drugs affecting gastrointestinal peristalsis in the past 3 months
- those with missing data at the time points of baseline, 3 months, and 6 months after GLP-1 RA therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China, Jiangsu, Department of Endocrinology
Xuzhou, China, 221006
Hongwei Ling, MD, 18052268607, linghongwei@medmail.com.cn
Renguo Chen, MD
About this study
Official title: Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University
This is a retrospective cohort study of patients with T2DM who were treated with exenatide twice daily as a part of their diabetes care for at least 12 months. The objective of this study is to investigate the influence of T2DM susceptibility gene polymorphisms (NOS1AP, KCNQ1, TCF7L2, WSF1, GLP-1R, etc.) on the efficacy of GLP-1 RA (exenatide, liraglutide, etc.), to identify the variables that can predict the efficacy of GLP-1 RA, and to evaluate the weight of these variables on the efficacy.
Read the detailed description
T2DM is a polygenic genetic disease. The individual differences in the efficacy of antidiabetic drugs are caused by the cumulative effect of multiple gene polymorphisms, and are related to environmental factors and lifestyle. The results of single gene polymorphism cannot fully explain the individual differences in the efficacy of antidiabetic drugs. Verifying the correlation between T2DM gene polymorphisms and the efficacy of antidiabetic drugs, clarifying the genetic determinants of individual differences in the efficacy of antidiabetic drugs, and predicting the efficacy and side effects of antidiabetic drugs are of great significance for the formulation of precise medication regimens for T2DM patients.
Many guidelines recommend the preferential use of GLP-1 RA after single drug or multiple oral hypoglycemic drugs and basic insulin therapy for poor glycemic control. However, the clinical responsiveness to GLP-1 RA varies among patients with T2DM. It has been reported that genetic factors are the important reasons for individual variation in therapeutic response of antidiabetic drugs. At present, dozens of gene loci related to therapeutic response of antidiabetic drugs have been screened, which are of great clinical significance in guiding clinical individualized treatment, improving the efficacy and safety of drugs, and reducing the drug costs.
GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months. The patients were visited at moths 0, 3, and 6, and medical histories, physical examinations, and routine clinical laboratory tests were performed during these visits. The general anthropometric parameters considered for this study were height (m), weight (kg), and waist and hip circumferences (cm) at baseline, 3 months and 6months after exenatide treatment.
Patients who had an HbA1c reduction ≥1.0% or HbA1c \<7.0% after exenatide treatment for six consecutive months were considered responders, while patients who failed to achieve this decrease were considered non-responders. The clinical data were collected and analyzed to determine the variables that could predict the efficacy of GLP-1 RA, and to evaluate the weight of the influence of these variables on the efficacy.
- Conditions
- Type 2 Diabetes Mellitus, Susceptibility, Genetic
- Being tested
- GLP-1 receptor agonist, responders group and nonresponders group
- Keywords
- Type 2 Diabetes Mellitus, GLP-1 RA, gene polymorphism, susceptibility gene, variation
- Medical subject headings
- Diabetes Mellitus, Type 2, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 receptor agonistDrug
Eligible patients with T2DM were required to have received GLP-1RA as monotherapy or in combination with other antidiabetic agents. GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months in patients with T2DM.
responders group and nonresponders groupDrug
For all the patients with type 2 diabetes who were initially enrolled in the study, blood samples were obtained for genotyping before the administration of GLP-1 receptor agonists. Patients were re-screened according to whether they had used GLP-1 RA continuously for more than 6 months and had completed the specified follow-up tasks.
Patients were divided according to the type of T2DM susceptibility genes. Or all were divided into responses group and nonresponses group according to whether they had glycemic response (△HbA1c↓ ≥1.0%) and weight response (△weight↓ ≥3.0%) after taking GLP-1 receptor agonist for 6 months.
According to the above grouping, the variables that can predict the efficacy of the drug were identified, and the weight of the influence of these variables on the efficacy was evaluated.
| Study group | Role | What they receive |
|---|---|---|
| efficacy difference of GLP-1RA | Experimental | Responders group and non-responders group Receives: Drug: GLP-1 receptor agonist; Drug: responders group and nonresponders group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline HbA1c and baseline weight at 6 month
In order to observe the change from baseline HbA1c and baseline weight at 6 month after GLP-1 RA treatment
Measured: 6 month after GLP-1 RA treatment
To identify and evaluate the variable factors influencing GLP-1 RA efficacy
The variable factors that predict the efficacy of GLP-1 RA were identified and the weight these variables on the efficacy was assessed
Measured: 1 month after sample integration
Genotype identification in patients with T2DM
Blood samples were collected from T2DM patients for genotyping
Measured: 1 month after sample collecting
Secondary outcomes (1)
Incidence and severity of possible adverse reaction within 6 month after GLP-1 RA treatment
To evaluate the incidence and severity of possible adverse reaction within 6 month after GLP-1 RA treatment, including gastrointestinal reaction and hypoglycemia
Measured: 6 months after GLP-1 RA treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Jan 2024
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256419
- Sponsor's protocol ID
- XYFY2023-KL479-01
- Status last verified
- Sep 2025
- First submitted
- 5 Feb 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University
- ClinicalTrials.gov ID
- NCT06256419
- Acronym / sponsor ID
- XYFY2023-KL479-01
- Conditions
- Type 2 Diabetes Mellitus, Susceptibility, Genetic
- Keywords
- Type 2 Diabetes Mellitus, GLP-1 RA, gene polymorphism, susceptibility gene, variation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 13 Feb 2024 (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.
This is a retrospective cohort study of patients with T2DM who were treated with exenatide twice daily as a part of their diabetes care for at least 12 months. The objective of this study is to investigate the influence of T2DM susceptibility gene polymorphisms (NOS1AP, KCNQ1, TCF7L2, WSF1, GLP-1R, etc.) on the efficacy of GLP-1 RA (exenatide, liraglutide, etc.), to identify the variables that can predict the efficacy of GLP-1 RA, and to evaluate the weight of these variables on the efficacy.
Detailed description
T2DM is a polygenic genetic disease. The individual differences in the efficacy of antidiabetic drugs are caused by the cumulative effect of multiple gene polymorphisms, and are related to environmental factors and lifestyle. The results of single gene polymorphism cannot fully explain the individual differences in the efficacy of antidiabetic drugs. Verifying the correlation between T2DM gene polymorphisms and the efficacy of antidiabetic drugs, clarifying the genetic determinants of individual differences in the efficacy of antidiabetic drugs, and predicting the efficacy and side effects of antidiabetic drugs are of great significance for the formulation of precise medication regimens for T2DM patients.
Many guidelines recommend the preferential use of GLP-1 RA after single drug or multiple oral hypoglycemic drugs and basic insulin therapy for poor glycemic control. However, the clinical responsiveness to GLP-1 RA varies among patients with T2DM. It has been reported that genetic factors are the important reasons for individual variation in therapeutic response of antidiabetic drugs. At present, dozens of gene loci related to therapeutic response of antidiabetic drugs have been screened, which are of great clinical significance in guiding clinical individualized treatment, improving the efficacy and safety of drugs, and reducing the drug costs.
GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months. The patients were visited at moths 0, 3, and 6, and medical histories, physical examinations, and routine clinical laboratory tests were performed during these visits. The general anthropometric parameters considered for this study were height (m), weight (kg), and waist and hip circumferences (cm) at baseline, 3 months and 6months after exenatide treatment.
Patients who had an HbA1c reduction ≥1.0% or HbA1c \<7.0% after exenatide treatment for six consecutive months were considered responders, while patients who failed to achieve this decrease were considered non-responders. The clinical data were collected and analyzed to determine the variables that could predict the efficacy of GLP-1 RA, and to evaluate the weight of the influence of these variables on the efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| efficacy difference of GLP-1RA | Experimental | Drug: GLP-1 receptor agonist, Drug: responders group and nonresponders groupResponders group and non-responders group |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a diagnosis of T2DM
- a body mass index (BMI) of 20-35 kg/m2
- an HbA1c of 7.0%-12%, an age of 25-70 years
- required data available at baseline and 6 months after GLP-1RA therapy.
Key exclusion criteria (3 listed)
- Patients with serious diseases such as acute myocardial infarction, cerebral vascular accident, trauma, kidney or liver diseases, severe gastrointestinal dysfunction, and history of pancreatitis
- patients receiving GLP-1 analogues, weight loss drugs, glucocorticoids, drugs affecting gastrointestinal peristalsis in the past 3 months
- those with missing data at the time points of baseline, 3 months, and 6 months after GLP-1 RA therapy.
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 |
|---|---|---|
| GLP-1 receptor agonistEligible patients with T2DM were required to have received GLP-1RA as monotherapy or in combination with other antidiabetic agents. GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months in patients with T2DM. | Drug | efficacy difference of GLP-1RA |
| responders group and nonresponders groupFor all the patients with type 2 diabetes who were initially enrolled in the study, blood samples were obtained for genotyping before the administration of GLP-1 receptor agonists. Patients were re-screened according to whether they had used GLP-1 RA continuously for more than 6 months and had completed the specified follow-up tasks. Patients were divided according to the type of T2DM susceptibility genes. Or all were divided into responses group and nonresponses group according to whether they had glycemic response (△HbA1c↓ ≥1.0%) and weight response (△weight↓ ≥3.0%) after taking GLP-1 receptor agonist for 6 months. According to the above grouping, the variables that can predict the efficacy of the drug were identified, and the weight of the influence of these variables on the efficacy was evaluated. | Drug | efficacy difference of GLP-1RA |
Primary outcome
Change from baseline HbA1c and baseline weight at 6 month
Time frame: 6 month after GLP-1 RA treatment
In order to observe the change from baseline HbA1c and baseline weight at 6 month after GLP-1 RA treatment
To identify and evaluate the variable factors influencing GLP-1 RA efficacy
Time frame: 1 month after sample integration
The variable factors that predict the efficacy of GLP-1 RA were identified and the weight these variables on the efficacy was assessed
Genotype identification in patients with T2DM
Time frame: 1 month after sample collecting
Blood samples were collected from T2DM patients for genotyping
1 secondary outcome
Incidence and severity of possible adverse reaction within 6 month after GLP-1 RA treatment
Time frame: 6 months after GLP-1 RA treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLP-1 receptor agonist and responders group and nonresponders group in people with Type 2 Diabetes Mellitus and Susceptibility, Genetic, run by The Affiliated Hospital of Xuzhou 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Sep 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Wang, Ph.D (13815344640, misswt2011@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline HbA1c and baseline weight at 6 month (time frame: 6 month after GLP-1 RA treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.