Clinical Trial Details
| Trial ID: | L6184 |
| Source ID: | NCT02609815 |
| Associated Drug: | Gemigliptin/Metformin |
| Title: | Initial Combination of Gemigliptin and Metformin on Microbiota Change |
| Acronym: | INTESTINE |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes |
| Interventions: | DRUG: gemigliptin/metformin|DRUG: glimepiride/metformin |
| Outcome Measures: | Primary: 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., 24 weeks | Secondary: HbA1c change, HbA1c change from baseline to 24 weeks, 24 weeks | Other: Body composition, Using bioimpedance analysis, muscle mass and total and visceral fat mass were analyzed after 24 week treatment., 24 weeks|Beta-cell function, HOMA-beta and insulinogenic index calculated before and after treatment., 24 weeks|GLP-1, Plasma levels of GLP-1 during 75g OGTT., 24 weeks|GIP, Plasma levels of GIP during 75g OGTT., 24 weeks|PYY, Plasma levels of PYY during 75g OGTT., 24 weeks |
| Sponsor/Collaborators: | Sponsor: Seoul National University Bundang Hospital |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | |
| Enrollment: | 70 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2015-11-01 |
| Completion Date: | 2021-03-15 |
| Results First Posted: | |
| Last Update Posted: | 2021-11-22 |
| Locations: | Seoul National University Bundang Hospital, Seongnam, Gyeonggi, 463-707, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT02609815 |
