Clinical Trial to Assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients

Study Overview
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Brief Summary
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Phase 3 study to assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients

Detailed Description
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Phase 3 study to assess the Efficacy and Safety of YYC405-T when added to Metformin and Dapagliflozin combination therapy in patients with type 2 diabetes mellitus who have inadequate glycemic control

Official Title
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A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of YYC405-T Added to Metformin and Dapagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With the Combination of Metformin and Dapagliflozin

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: YYC405-T
* Drug: Metformin≥1000mg
* Drug: Dapagliflozin 10mg
* Drug: YYC405-T placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who contsent to participate in this tiral by written informed consent form A man or woman over 20 years old Type 2 Diabetes patients Exclusion Criteria: Patients with severe renal impairment, end-stage renal disease or on dialysis Type 1 diabetes patients Patients with a history of acute or chronic target acidosis, including lactic acidosis and diabetic ketoacidosis

Ages Eligible for Study
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Minimum Age: 20 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
Interventional Model Description: a Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel group
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Take YYC405-T and Metformin≥1000mg, Dapagliflozin 10mg | Drug: YYC405-T<br>* Subjects take the investigational products once a day for 24 weeks.<br>Drug: Metformin≥1000mg<br>* Subjects take the investigational products once a day for 24 weeks.<br>Drug: Dapagliflozin 10mg<br>* Subjects take the investigational products once a day for 24 weeks.<br>|
| Placebo Comparator: Placebo control<br>Take YYC405-T Placebo and Metformin≥1000mg, Dapagliflozin 10mg | Drug: Metformin≥1000mg<br>* Subjects take the investigational products once a day for 24 weeks.<br>Drug: Dapagliflozin 10mg<br>* Subjects take the investigational products once a day for 24 weeks.<br>Drug: YYC405-T placebo<br>* Microcrystalline cellulose, Subjects take the investigational products once a day for 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Change from baseline in Glycosylated Hemoglobin (HbA1c) | Baseline, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Change from baseline in Glycosylated Hemoglobin (HbA1c) | Baseline, 12weeks | 
| FPG, Fasting insulin | Change from baseline in Fasing plasma glucose and Fasting insulin | Baseline, 12weeks, 24weeks | 
| C-peptide | Change from baseline in C-peptide | Baseline, 12weeks, 24weeks |