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

Seoul National University

Status: Completed

Conditions: Diabetes

Treatments: Drug: gemigliptin/metformin; Drug: glimepiride/metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02609815

SNUBH-INTESTINE2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

gemigliptin/metformin

Experimental group

Description:

zemimet-SR 50/1000 mg x 1 tablet

Treatment:

Drug: gemigliptin/metformin

glimepiride/metformin

Active Comparator group

Description:

amaryl-Mex 1/500 mg x 2 tablets

Treatment:

Drug: glimepiride/metformin