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Not yet recruiting NCT07365358

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

Phase IV Interventional Diabete Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: empagliflozin 10mg, Glimepiride 1mg.
Who it may be relevant to
Registry conditions: Diabete Type 2. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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 Inadequately Controlled With Metformin and Sitagliptin

Overview

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

Detailed 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

Interventions

  • Drug empagliflozin 10mg
    once a day for 24 weeks
  • Drug Glimepiride 1mg
    once a day for 24 weeks

Primary outcome measures

  • Percentage of subjects who meet 3 conditions at the same time [Time frame: Baseline and Week 24]
Secondary outcome measures (2)
  • Percentage of subjects who meet 3 conditions at the same time [Time frame: Baseline and Week 12]
  • Change from baseline in HbA1c and FPG [Time frame: Baseline and Week 24]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Kyung Hee University Hospital at Gangdong — Seoul

Identifiers

NCT: NCT07365358 · B91_02DM2502

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗