Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period. At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial. The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.

Detailed Description
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The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period. Throughout this period, subjects will receive concurrent administration of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day), and will have a washout period for other oral antidiabetic drugs. At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial. The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.

Official Title
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A Multi-center, phase3, Open-label Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Gemigliptin

Conditions
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T2DM (Type 2 Diabetes Mellitus)

Intervention / Treatment
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* Drug: DWP16001 0.3 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with T2DM age 19   under 80 years Subjects who have 7% ≤ HbA1c ≤ 11% in screening visit(V1-1) Subjects who have FPG <270 mg/dl screening visit(V1-1) Subjects who have received a combination of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day) for a minimum of 8 weeks prior to Visit 2 (Enrollment Visit) Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study Exclusion Criteria: Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors) Diabetic ketoacidosis, diabetic coma or precoma within the past year Urinary tract infections or genital infections within Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg) eGFR < 45 mL/min/1.73 m2 Severe heart failure (NYHA class III/IV

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 79 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group (DWP16001 0.3 mg)<br>DWP16001 0.3mg, Tablets, Orally, Once daily | Drug: DWP16001 0.3 mg<br>* DWP16001 0.3mg, Tablets, Orally, Once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety outcomes_Adverse events occurred during clinical trials | Safety outcomes_Adverse events occurred during clinical trials | from baseline up to 52 weeks | 
| Safety outcomes_ Change of blood pressure | Safety outcomes_ Change of blood pressure | from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP | 
| Safety outcomes_ Change of heartbeat | Safety outcomes_ Change of heartbeat | from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP | 
| Safety outcomes_ Change of body temperature | Safety outcomes_ Change of body temperature | from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP | 
| Efficacy outcome_Change of HbA1c | Efficacy outcome_Change of HbA1c | from Baseline at Week 8, 16, 24, 38, and 52 after administration of the IP | 
| Efficacy outcome_Change of FPG | Efficacy outcome_Change of FPG | from baseline at Week 8, 16, 24, 38, and 52 after administration of the IP | 
| Efficacy outcome_Proportion of subjects achieving HbA1c target of < 6.5% | Efficacy outcome_Proportion of subjects achieving HbA1c target of < 6.5% | at Weeks 8, 16, 24, 38 and 52 after administration of the IP | 
| Efficacy outcome_Proportion of subjects achieving HbA1c target of < 7.0 % | Efficacy outcome_Proportion of subjects achieving HbA1c target of < 6.5% | at Weeks 8, 16, 24, 38 and 52 after administration of the IP |