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

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

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Drug: Evogliptin 5mg
* Drug: Evogliptin Placebo
* Drug: Dapagliflozin 10mg
* 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 Subjects who performed Dual therapies (complex allowed) for one of the following, along with meals and exercise therapy Subjects who are receiving metformin ≥ 1000 mg/d and dapagliflozin 10 mg/d at the same dose for at least 8 weeks prior to the screening visit Subjects who are receiving metformin ≥ 1000 mg/d and SGLT-2 inhibitor except for dapagliflozin at the same dose for at least 8 weeks prior to the screening visit Subjects with 7.0%≤HbA1c≤10.5% at screening visit Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening visit Exclusion Criteria: Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic ketoacidosis, diabetic coma, pre-coma, lactic acidosis, and acute or chronic metabolic acidosis patients with Hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia Patients with severe infectious disease or severe traumatic systemic disorders End stage renal disease or dialysis patients Patients with Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption Subjects with Liver cirrhosis, chronic active hepatitis B or C, cholecystitis, acromegaly, asthma or major skin allergies

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evogliptin 5mg group<br>Evogliptin 5mg/d + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d | Drug: Evogliptin 5mg<br>* Participants receive Evogliptin 5mg orally once a day<br>* Other names: Suganon;Drug: Dapagliflozin 10mg<br>* Participants receive Dapagliflozin orally once a day<br>* Other names: Forxiga;Drug: Metformin ≥ 1000mg<br>* Metformin are administered at the same dose and formulation.<br>|
| Placebo Comparator: Evogliptin Placebo group<br>Evogliptin Placebo + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d | Drug: Evogliptin Placebo<br>* Participants receive placebo to match Evogliptin 5mg orally once a day<br>* Other names: Placebo;Drug: Dapagliflozin 10mg<br>* Participants receive Dapagliflozin orally once a day<br>* Other names: Forxiga;Drug: Metformin ≥ 1000mg<br>* Metformin are administered at the same dose and formulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c (%) After 24 weeks |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in FPG(mg/dL) After 24 weeks |  | 24 weeks | 
| Change from baseline in HbA1c response rate(<7.0% ,<6.5%) After 24 weeks |  | 24 weeks | 
| Change from baseline in 7-point SMBG After 24 weeks |  | 24 weeks |