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)

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.

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.

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