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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorChong Kun Dang Pharmaceutical

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • empagliflozin 10mg

    Drug

    once a day for 24 weeks

  • Glimepiride 1mg

    Drug

    once a day for 24 weeks

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Expermental group 1Experimental treatment 1 intervention
Group B: Expermental group 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of subjects who meet 3 conditions at the same time

1. No hypoglycemic events(\<70mg/dL) for 24 weeks 2. No weight change at 24 week 3. HbA1c \<7.0% at 24 week

Time frame
Baseline and Week 24

Secondary outcomes

1

Percentage of subjects who meet 3 conditions at the same time

1. No hypoglycemic events(\<70mg/dL) for 12 weeks 2. No weight change at 12 week 3. HbA1c \<7.0% at 12 week

Time frame
Baseline and Week 12
2

Change from baseline in HbA1c and FPG

Time frame
Baseline and Week 24

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: