Initial Combination of Gemigliptin and Metformin on Microbiota Change
INTESTINE
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)
1 other identifier
interventional
70
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes
Started Nov 2015
Longer than P75 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 13, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2021
CompletedNovember 22, 2021
November 1, 2021
5.4 years
November 13, 2015
November 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
HbA1c change
24 weeks
Other Outcomes (5)
Body composition
24 weeks
Beta-cell function
24 weeks
GLP-1
24 weeks
- +2 more other outcomes
Study Arms (2)
gemigliptin/metformin
EXPERIMENTALzemimet-SR 50/1000 mg x 1 tablet
glimepiride/metformin
ACTIVE COMPARATORamaryl-Mex 1/500 mg x 2 tablets
Interventions
zemimet-SR 50/1000 mg x 1 tablet
amaryl-Mex 1/500 mg x 2 tablets
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- Drug naive (no anti-diabetic medication within 6 weeks)
- HbA1c \>= 7.5%
- BMI \>= 25.0 kg/m2
You may not qualify if:
- Type 1 diabetes
- DKA, HHS
- history of hypersensitivity to sulphonylurea, metformin or DPP-4 inhibitor
- Gestational diabetes mellitus
- Serum Cr \>1.5 mg/dL (male), \>1.4mg/dL (female)
- Abnormal liver function test
- Anti-obesity medication within 3 months
- Gastrointestinal motility drug, laxatives within 3 months
- History of major gastrointestinal surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tae Jung Oh
Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 13, 2015
First Posted
November 20, 2015
Study Start
November 1, 2015
Primary Completion
March 15, 2021
Study Completion
March 15, 2021
Last Updated
November 22, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share