An interventional study of GLP-1 receptor agonist in Type 2 Diabetes Mellitus, sponsored by The Affiliated Hospital of Xuzhou Medical University. Completed at 1 site in China. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by The Affiliated Hospital of Xuzhou Medical University · Not applicable, Interventional, and Treatment
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 338 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →The Affiliated Hospital of Xuzhou Medical University is the lead sponsor of 70 studies on the registry; 33 are open to participants now.
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Exclusion Criteria:
GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months.
Drug: GLP-1 receptor agonist
GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months in patients with T2DM
Also known as: GLP-1 analogues
Change from baseline HbA1c at 1 month
In order to observe the change from baseline HbA1c at 1 month after GLP-1 RA treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 month after GLP-1 RA treatment
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
Time frame: 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
Time frame: 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
Time frame: 6 month after GLP-1 RA treatment
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2019 to primary completion in Oct 2023, 56 months.
Of 1,924 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's 56 months is above that.
Counting every sponsor, half of 2,101 studies reached it within 20 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: GLP-1 Mimetic
The Affiliated Hospital of Xuzhou Medical University