Efficacy and Safety of Dapagliflozin When Added to Ongoing Metformin and Evogliptin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

Study Overview
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Brief Summary
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This study evaluates the addition of dapagliflozin in the treatment of type 2 diabetes with metformin and evogliptin combination therapy. Half of subjects will receive dapagliflozin, metformin and evogliptin, while the other half will receive placebo, metformin and evogliptin.

Official Title
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A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Dapagliflozin When Added to Ongoing Metformin and Evogliptin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Dapagliflozin 10mg
* Drug: Placebo
* Drug: Evogliptin 5mg
* Drug: Metformin≥1000mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with type II diabetes mellitus aged 19 years or older Patients who had taken metformin(≥1000mg/day) and DPP(dipeptidyl peptidase)-4 inhibitor combination therapy(or complex is allowed) at the same dose for at least 8 weeks prior to the screening visit Patients with fasting plasma glucose≤250mg/dL at the screening visit Patients with 18.5kg/m^2≤BMI≤40kg/m^2 at the screening visit Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study Exclusion Criteria: Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis Patients with a medical history of New York Heart Association(NYHA) class III IV heart failure or with congestive heart failure, acute and unstable heart failure Patients with severe infectious disease or severe traumatic systemic disorders Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia Patients with galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption Patients with moderate to severe stage renal disease, end stage renal disease, dialysis at the time of screening visit

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapagliflozin 10mg + Evogliptin 5mg + Metformin<br> | Drug: Dapagliflozin 10mg<br>* Dapagliflozin 10mg, orally, once daily, up to 24weeks<br>* Other names: Forxiga;Drug: Evogliptin 5mg<br>* Evogliptin 5mg, orally, once daily for background therapy<br>* Other names: Suganon;Drug: Metformin≥1000mg<br>* Metformin≥1000mg, orally, daily for background therapy<br>|
| Placebo Comparator: Dapagliflozin Placebo + Evogliptin 5mg + Metformin<br> | Drug: Placebo<br>* Dapagliflozin Placebo, orally, once daily, up to 24weeks<br>Drug: Evogliptin 5mg<br>* Evogliptin 5mg, orally, once daily for background therapy<br>* Other names: Suganon;Drug: Metformin≥1000mg<br>* Metformin≥1000mg, orally, daily for background therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from the baseline in HbA1c (%) after 24 weeks |  | Baseline, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks |  | Baseline, 24 weeks | 
| Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks |  | Baseline, 24 weeks | 
| Change from the baseline in weight after 24 weeks |  | Baseline, 24 weeks |