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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02609815
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : October 8, 2019
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetes Drug: gemigliptin/metformin Drug: glimepiride/metformin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 1, 2015
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

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 Name: 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 Name: Amarylmex

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. HbA1c change [ Time Frame: 24 weeks ]
    HbA1c change from baseline to 24 weeks

Other Outcome Measures:
  1. Body composition [ Time Frame: 24 weeks ]
    Using bioimpedance analysis, muscle mass and total and visceral fat mass were analyzed after 24 week treatment.

  2. Beta-cell function [ Time Frame: 24 weeks ]
    HOMA-beta and insulinogenic index calculated before and after treatment.

  3. GLP-1 [ Time Frame: 24 weeks ]
    Plasma levels of GLP-1 during 75g OGTT.

  4. GIP [ Time Frame: 24 weeks ]
    Plasma levels of GIP during 75g OGTT.

  5. PYY [ Time Frame: 24 weeks ]
    Plasma levels of PYY during 75g OGTT.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02609815

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Contact: Tae Jung Oh 82-31-787-7078

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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Contact: Soo Lim, MD, PHD    82-31-787-7035   
Contact: Tae Jung Oh, MD, PHD    82-31-787-7078   
Principal Investigator: Soo Lim, MD, PHD         
Sponsors and Collaborators
Seoul National University Bundang Hospital
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Study Director: Tae Jung Oh Seoul National University Bundang Hospital

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Responsible Party: Soo Lim, Associate Professor, Seoul National University Bundang Hospital Identifier: NCT02609815    
Other Study ID Numbers: SNUBH-INTESTINE2015
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors