Initial Combination of Gemigliptin and Metformin on Microbiota Change

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02609815

Acronym

INTESTINE

Enrollment

Registered

2015-11-20

Start date

2015-11-01

Completion date

2021-03-15

Last updated

2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

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.

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.

Interventions

DRUGgemigliptin/metformin

zemimet-SR 50/1000 mg x 1 tablet

DRUGglimepiride/metformin

amaryl-Mex 1/500 mg x 2 tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
gut microbiota composition change from baseline	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

Measure	Time frame	Description
HbA1c change	24 weeks	HbA1c change from baseline to 24 weeks

Other

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026