Initial Combination of Gemigliptin and Metformin on Microbiota Change

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Drug: gemigliptin/metformin; Drug: glimepiride/metformin

• Registration Number: NCT02609815
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-11-01
• Study First Submitted: 2015-11-13
• Study First Submitted QC: 2015-11-17
• Study First Posted: 2015-11-20
• Primary Completion: 2021-03-15
• Study Completion: 2021-03-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-19
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Type 2 diabetes
• Drug naive (no anti-diabetic medication within 6 weeks)
• HbA1c >= 7.5%
• BMI >= 25.0 kg/m2

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gemigliptin/metformin	gemigliptin/metformin	zemimet-SR 50/1000 mg x 1 tablet
glimepiride/metformin	glimepiride/metformin	amaryl-Mex 1/500 mg x 2 tablets

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
HbA1c change	24 weeks	HbA1c change from baseline to 24 weeks

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of