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)

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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