Initial Combination of Gemigliptin and Metformin on Microbiota Change (INTESTINE)

November 19, 2021 updated by: Soo Lim, Seoul National University Bundang Hospital

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: gemigliptin/metformin
zemimet-SR 50/1000 mg x 1 tablet
Drug: gemigliptin/metformin
zemimet-SR 50/1000 mg x 1 tablet
Other Names:
  • Zemimet
Active Comparator: glimepiride/metformin
amaryl-Mex 1/500 mg x 2 tablets
Drug: glimepiride/metformin
amaryl-Mex 1/500 mg x 2 tablets
Other Names:
  • Amarylmex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gut microbiota composition change from baseline
Time Frame: 24 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c change
Time Frame: 24 weeks
HbA1c change from baseline to 24 weeks
24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: 24 weeks
Using bioimpedance analysis, muscle mass and total and visceral fat mass were analyzed after 24 week treatment.
24 weeks
Beta-cell function
Time Frame: 24 weeks
HOMA-beta and insulinogenic index calculated before and after treatment.
24 weeks
GLP-1
Time Frame: 24 weeks
Plasma levels of GLP-1 during 75g OGTT.
24 weeks
GIP
Time Frame: 24 weeks
Plasma levels of GIP during 75g OGTT.
24 weeks
PYY
Time Frame: 24 weeks
Plasma levels of PYY during 75g OGTT.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Study Director: Tae Jung Oh, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

March 15, 2021

Study Completion (Actual)

March 15, 2021

Study Registration Dates

First Submitted

November 13, 2015

First Submitted That Met QC Criteria

November 17, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 19, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH-INTESTINE2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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