Initial Combination of Gemigliptin and Metformin on Microbiota Change

Diabetes Clinical Trial

— INTESTINE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609815
• Other study ID #: SNUBH-INTESTINE2015
• Status: Completed
• Phase: N/A
• Start date: November 1, 2015
• Est. completion date: March 15, 2021

Study information

• Verified date: November 2021
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• gemigliptin/metformin
zemimet-SR 50/1000 mg x 1 tablet
• glimepiride/metformin
amaryl-Mex 1/500 mg x 2 tablets

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body composition	Using bioimpedance analysis, muscle mass and total and visceral fat mass were analyzed after 24 week treatment.	24 weeks
Other	Beta-cell function	HOMA-beta and insulinogenic index calculated before and after treatment.	24 weeks
Other	GLP-1	Plasma levels of GLP-1 during 75g OGTT.	24 weeks
Other	GIP	Plasma levels of GIP during 75g OGTT.	24 weeks
Other	PYY	Plasma levels of PYY during 75g OGTT.	24 weeks
Primary	gut microbiota composition change from baseline	Analysis of gut microbiota composition at class, genus, and species levels before and after treatment. Inter-individual changes of gut microbiota changes were analyzed.	24 weeks
Secondary	HbA1c change	HbA1c change from baseline to 24 weeks	24 weeks