An interventional study of gemigliptin/metformin and glimepiride/metformin in Diabetes, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-11-22.
Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Treatment
The purpose of this study is to investigate gut microbiota change and glucose lowering effect of initial combination therapy of gemigliptin and metformin compared to glimepiride and metformin in obese patients with type 2 diabetes.
Obese type 2 diabetes patients who were not treated with anti-diabetic medication within 6 weeks, were randomly assigned to gemigliptin/metformin or sulphonylurea/metformin. After 24 week treatment, gut microbiota composition change, glucose lowering effect, body weight, and gut hormones were compared between two groups.
Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
zemimet-SR 50/1000 mg x 1 tablet
Drug: gemigliptin/metformin
amaryl-Mex 1/500 mg x 2 tablets
Drug: glimepiride/metformin
zemimet-SR 50/1000 mg x 1 tablet
Also known as: Zemimet
amaryl-Mex 1/500 mg x 2 tablets
Also known as: Amarylmex
gut microbiota composition change from baseline
Analysis of gut microbiota composition at class, genus, and species levels before and after treatment. Inter-individual changes of gut microbiota changes were analyzed.
Time frame: 24 weeks
HbA1c change
HbA1c change from baseline to 24 weeks
Time frame: 24 weeks
Body composition
Using bioimpedance analysis, muscle mass and total and visceral fat mass were analyzed after 24 week treatment.
Time frame: 24 weeks
Beta-cell function
HOMA-beta and insulinogenic index calculated before and after treatment.
Time frame: 24 weeks
GLP-1
Plasma levels of GLP-1 during 75g OGTT.
Time frame: 24 weeks
GIP
Plasma levels of GIP during 75g OGTT.
Time frame: 24 weeks
PYY
Plasma levels of PYY during 75g OGTT.
Time frame: 24 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Seoul National University Bundang Hospital