Skip to main content
OpenTrials
Completed

NCT Number: NCT02609815

Initial Combination of Gemigliptin and Metformin on Microbiota Change

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gemigliptin/metformin

Drug

zemimet-SR 50/1000 mg x 1 tablet

Other names: Zemimet

glimepiride/metformin

Drug

amaryl-Mex 1/500 mg x 2 tablets

Other names: Amarylmex

Primary outcomes

  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 outcomes

  1. HbA1c change

    Time frame: 24 weeks

    HbA1c change from baseline to 24 weeks

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study 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)

Acronym: INTESTINE

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2015
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.