The Efficacy and Safety of DWP16001 Compared to Placebo in the Treatment of Type 2 Diabetes Mellitus.

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and safety of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.

Official Title
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A Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus

Conditions
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T2DM (Type 2 Diabetes Mellitus)

Intervention / Treatment
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* Drug: DWP16001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 19 to 80 years Subjects with 7% ≤ HbA1c ≤ 10% who have been diagnosed with T2DM at least 8 weeks Subjects with BMI of 20-45 kg/m2 Subjects who have been on a stable diet and exercise program for at least 8 weeks Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study Exclusion Criteria: Different type of diabetes mellitus which is not T2DM (type 1 diabetes mellitus, secondary diabetes mellitus, or congenital renal glucosuria) Symptoms of stress urinary incontinence, dysuria that is not controlled by medications due to neurogenic bladder or prostatic hyperplasia, anuria, oliguria, or urinary retention Severe diabetes complications (proliferative diabetic retinopathy, nephropathy of stage 4 or higher, or serious diabetic neuropathy) eGFR < 60 mL/min/1.73 m2 Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc. Uncontrolled hypertension (SBP >180 mmHg or DBP > 110 mmHg)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWP16001 Amg<br>DWP16001 Amg, Tablets, Orally, Once daily | Drug: DWP16001<br>* DWP16001 A mg<br>|
| Placebo Comparator: DWP16001 Amg Placebo<br>DWP16001 Amg Placebo, Tablets, Orally, Once daily | Drug: DWP16001<br>* DWP16001 A mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c level at Week 24 after administration of the IP | 1.Change from Visit 2 (randomization) in HbA1c level at Week 24 after administration of the IP | at Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c level at Weeks 6, 12, and 18 after administration of the IP | 1.Changes from Visit 2 (randomization) in HbA1c level at Weeks 6, 12, and 18 after administration of the IP | at weeks 6, 12, and 18 | 
| FPG level at Weeks 6, 12, 18, and 24 after administration of the IP | 2.Changes from Visit 2 (randomization) in FPG level at Weeks 6, 12, 18, and 24 after administration of the IP | at weeks 6, 12, 18, and 24 | 
| HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP | 3.Proportions of subjects who achieved HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP | at weeks 6, 12, 18, and 24 |