Trials / Completed
CompletedNCT02609815
Initial Combination of Gemigliptin and Metformin on Microbiota Change
Effect of INitial Combination Therapy With GEmigliptin and Metformin on Microbiota Change and Glycemic Control in patientS With Type 2 DIabetes aNd ObEsity (INTESTINE Study)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Seoul National University Bundang Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | gemigliptin/metformin | zemimet-SR 50/1000 mg x 1 tablet |
| DRUG | glimepiride/metformin | amaryl-Mex 1/500 mg x 2 tablets |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2021-03-15
- Completion
- 2021-03-15
- First posted
- 2015-11-20
- Last updated
- 2021-11-22
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02609815. Inclusion in this directory is not an endorsement.