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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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