Type 2 Diabetes MellitusNCT05037045
Effect of Gene Polymorphisms on GLP-1 Receptor Agonists Response in Patients With T2DM
A study testing GLP-1 receptor agonist in people with Type 2 Diabetes Mellitus, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
1. This is an prospective study to evaluate the effect of gene polymorphisms on therapeutic responses to glucagon like peptide-1 receptor agonist (GLP-1 RA) in patients with T2DM. 2. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- GLP-1 receptor agonist
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2019to 2 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 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, 3 months, and 6 months after GLP-1 RA 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.
About this study
Official title: Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University
- This is an prospective study to evaluate the effect of gene polymorphisms on therapeutic responses to glucagon like peptide-1 receptor agonist (GLP-1 RA) in patients with T2DM.
- T2DM patients and healthy subjects were recruited to identify genotypes and detect the level of T2DM susceptibility genes expression levels in the plasma of healthy participants and T2DM patients.
- 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.
Read the detailed description
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. After an overnight fast, venous blood samples were obtained both in the fasting state and 2 h later during a standard 75-g oral glucose tolerance test. Parameters were measured at baseline, the end of months 3 and 6 after administration of exenatide.
Peripheral blood was collected at follow-up and genomic DNA was extracted from peripheral blood leucocytes. We further explored the association of gene polymorphisms with the therapeutic effect of GLP-1 RA in patients with T2DM.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- GLP-1 receptor agonist
- Keywords
- T2DM, GLP-1 RA, gene polymorphism
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 receptor agonistDrug
Also called GLP-1 analogues
GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months in patients with T2DM
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 RA therapy | Experimental | GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months. Receives: Drug: GLP-1 receptor agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline HbA1c at 1 month
In order to observe the change from baseline HbA1c at 1 month after GLP-1 RA treatment
Measured: 1 month after GLP-1 RA treatment
Change from baseline FPG at 1 month
In order to observe the change from baseline FPG at 1 month after GLP-1 RA treatment
Measured: 1 month after GLP-1 RA treatment
Change from baseline PPG at 1 month
In order to observe the change from baseline PPG at 1 month after GLP-1 RA treatment
Measured: 1 month after GLP-1 RA treatment
Change from baseline serum lipids at 1 month
In order to observe the change from baseline serum lipids at 1 month after GLP-1 RA treatment
Measured: 1 month after GLP-1 RA treatment
Change from baseline HbA1c at 3 month
In order to observe the change from baseline HbA1c at 3 month after GLP-1 RA treatment
Measured: 3 month after GLP-1 RA treatment
Change from baseline FPG at 3 month
In order to observe the change from baseline FPG at 3 month after GLP-1 RA treatment
Measured: 3 month after GLP-1 RA treatment
Change from baseline PPG at 3 month
In order to observe the change from baseline PPG at 3 month after GLP-1 RA treatment
Measured: 3 month after GLP-1 RA treatment
Change from baseline serum lipids at 3 month
In order to observe the change from baseline serum lipids at 3 month after GLP-1 RA treatment
Measured: 3 month after GLP-1 RA treatment
Change from baseline HbA1c at 6 month
In order to observe the change from baseline HbA1c at 6 month after GLP-1 RA treatment
Measured: 6 month after GLP-1 RA treatment
Change from baseline FPG at 6 month
In order to observe the change from baseline FPG at 6 month after GLP-1 RA treatment
Measured: 6 month after GLP-1 RA treatment
Change from baseline PPG at 6 month
In order to observe the change from baseline PPG at 6 month after GLP-1 RA treatment
Measured: 6 month after GLP-1 RA treatment
Change from baseline serum lipids at 6 month
In order to observe the change from baseline serum lipids at 6 month after GLP-1 RA treatment
Measured: 6 month after GLP-1 RA treatment
Secondary outcomes (3)
incidence and severity of possible adverse reaction within 1 month after GLP-1 RA treatment
To evaluate the incidence and severity of possible adverse reaction within 1 month after GLP-1 RA treatment, including gastrointestinal reaction and hypoglycemia
Measured: 1 month after GLP-1 RA treatment
incidence and severity of possible adverse reaction within 3 month after GLP-1 RA treatment
To evaluate the incidence and severity of possible adverse reaction within 3 month after GLP-1 RA treatment, including gastrointestinal reaction and hypoglycemia
Measured: 3 month after GLP-1 RA treatment
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 month 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 posted8 Sep 2021
- Study start10 Jan 2019
- Primary completion1 Oct 2023
- Study completion2 Jan 2024
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renhao Wang, Ph.D, Study director, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037045
- Sponsor's protocol ID
- XYFY2018-KL085
- Status last verified
- Nov 2024
- First submitted
- 27 Aug 2021
- Last updated
- 12 Nov 2024
- 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 12 Nov 2024. 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
- NCT05037045
- Acronym / sponsor ID
- XYFY2018-KL085
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- T2DM, GLP-1 RA, gene polymorphism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 8 Sep 2021 (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 an prospective study to evaluate the effect of gene polymorphisms on therapeutic responses to glucagon like peptide-1 receptor agonist (GLP-1 RA) in patients with T2DM.
- T2DM patients and healthy subjects were recruited to identify genotypes and detect the level of T2DM susceptibility genes expression levels in the plasma of healthy participants and T2DM patients.
- 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.
Detailed description
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. After an overnight fast, venous blood samples were obtained both in the fasting state and 2 h later during a standard 75-g oral glucose tolerance test. Parameters were measured at baseline, the end of months 3 and 6 after administration of exenatide.
Peripheral blood was collected at follow-up and genomic DNA was extracted from peripheral blood leucocytes. We further explored the association of gene polymorphisms with the therapeutic effect of GLP-1 RA in patients with T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLP-1 RA therapy | Experimental | Drug: GLP-1 receptor agonistGLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months. |
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, 3 months, and 6 months after GLP-1 RA 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 agonistAlso: GLP-1 analoguesGLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months in patients with T2DM | Drug | GLP-1 RA therapy |
Primary outcome
Change from baseline HbA1c at 1 month
Time frame: 1 month after GLP-1 RA treatment
In order to observe the change from baseline HbA1c at 1 month after GLP-1 RA treatment
Change from baseline FPG at 1 month
Time frame: 1 month after GLP-1 RA treatment
In order to observe the change from baseline FPG at 1 month after GLP-1 RA treatment
Change from baseline PPG at 1 month
Time frame: 1 month after GLP-1 RA treatment
In order to observe the change from baseline PPG at 1 month after GLP-1 RA treatment
Change from baseline serum lipids at 1 month
Time frame: 1 month after GLP-1 RA treatment
In order to observe the change from baseline serum lipids at 1 month after GLP-1 RA treatment
Change from baseline HbA1c at 3 month
Time frame: 3 month after GLP-1 RA treatment
In order to observe the change from baseline HbA1c at 3 month after GLP-1 RA treatment
Change from baseline FPG at 3 month
Time frame: 3 month after GLP-1 RA treatment
In order to observe the change from baseline FPG at 3 month after GLP-1 RA treatment
Change from baseline PPG at 3 month
Time frame: 3 month after GLP-1 RA treatment
In order to observe the change from baseline PPG at 3 month after GLP-1 RA treatment
Change from baseline serum lipids at 3 month
Time frame: 3 month after GLP-1 RA treatment
In order to observe the change from baseline serum lipids at 3 month after GLP-1 RA treatment
Change from baseline HbA1c at 6 month
Time frame: 6 month after GLP-1 RA treatment
In order to observe the change from baseline HbA1c at 6 month after GLP-1 RA treatment
Change from baseline FPG at 6 month
Time frame: 6 month after GLP-1 RA treatment
In order to observe the change from baseline FPG at 6 month after GLP-1 RA treatment
Change from baseline PPG at 6 month
Time frame: 6 month after GLP-1 RA treatment
In order to observe the change from baseline PPG at 6 month after GLP-1 RA treatment
Change from baseline serum lipids at 6 month
Time frame: 6 month after GLP-1 RA treatment
In order to observe the change from baseline serum lipids at 6 month after GLP-1 RA treatment
3 secondary outcomes
incidence and severity of possible adverse reaction within 1 month after GLP-1 RA treatment
Time frame: 1 month after GLP-1 RA treatment
incidence and severity of possible adverse reaction within 3 month after GLP-1 RA treatment
Time frame: 3 month after GLP-1 RA treatment
incidence and severity of possible adverse reaction within 6 month after GLP-1 RA treatment
Time frame: 6 month after GLP-1 RA treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- 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. This study is not recruiting at the moment.
Renhao Wang, Ph.D study director
The Affiliated Hospital of Xuzhou Medical University
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 in people with Type 2 Diabetes Mellitus, 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: finished, as of the sponsor's last update on 12 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline HbA1c at 1 month (time frame: 1 month after GLP-1 RA treatment). The study lists 12 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 12 Nov 2024.