Evaluate the Efficacy and Safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients (EMPAGO)

Chong Kun Dang

Status and phase

Begins enrollment this month

Phase 4

Conditions

Diabete Type 2

Treatments

Drug: empagliflozin 10mg

Drug: Glimepiride 1mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT07365358

B91_02DM2502

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients

Full description

This study is a Multi-center, Randomized, Open-label, Active comparator-controlled, Phase 4 Clinical Trial to evaluate the efficacy and safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients

Enrollment

200 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Over 19 years old
Type 2 diabetes mellitus
Patient who has been taking oral hypoglycemic agents for over 8 weeks
Agreement with written informed consent

Exclusion criteria

Type 1 diabetes mellitus or secondary diabetes mellitus
Patients with complications of severe diabetes such as proliferative diabetic retinopathy
Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Patients with abnormal laboratory test results according to the protocol
Continuous or non-continuous treatment with insulin for over 7 days within 12 weeks prior to screening
History of treatment with corticosteroids within 4 weeks prior to screening

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Expermental group 1

Experimental group

Description:

Empamax® 10mg

Treatment:

Drug: empagliflozin 10mg

Expermental group 2

Active Comparator group

Description:

Amaryl® 1mg

Treatment:

Drug: Glimepiride 1mg

Trial contacts and locations

Central trial contact

In-Kyung Jeong, MD, PhD

Data sourced from clinicaltrials.gov

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