MedDataX Logo

Initial Combination of Gemigliptin and Metformin on Microbiota Change

NCT ID: NCT02609815

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-01

Study Completion Date

2021-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

gemigliptin/metformin

zemimet-SR 50/1000 mg x 1 tablet

Group Type EXPERIMENTAL

gemigliptin/metformin

Intervention Type DRUG

zemimet-SR 50/1000 mg x 1 tablet

glimepiride/metformin

amaryl-Mex 1/500 mg x 2 tablets

Group Type ACTIVE_COMPARATOR

glimepiride/metformin

Intervention Type DRUG

amaryl-Mex 1/500 mg x 2 tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

gemigliptin/metformin

zemimet-SR 50/1000 mg x 1 tablet

Intervention Type DRUG

glimepiride/metformin

amaryl-Mex 1/500 mg x 2 tablets

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zemimet Amarylmex

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Type 2 diabetes
* Drug naive (no anti-diabetic medication within 6 weeks)
* HbA1c \>= 7.5%
* BMI \>= 25.0 kg/m2

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Soo Lim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tae Jung Oh

Role: STUDY_DIRECTOR

Seoul National University Bundang Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SNUBH-INTESTINE2015

Identifier Type: -

Identifier Source: org_study_id