Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With 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 2, Therapeutic Exploratory 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
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 20 to 80 years Patients who was diagnosed with type 2 diabetes mellitus at least 8 weeks before Body Mass Index (BMI) between 20 and 45 kg/㎡ Patients with 7% ≤ HbA1c ≤ 10% at screening Subject who has conducted a stable diet and exercise for at least 8 weeks Exclusion Criteria: Type 1 diabetes mellitus or secondary diabetes Severe diabetes complications (proliferative diabetic retinopathy, stage 4 or higher nephropathy or severe diabetic neuropathy, diabetic ketoacidosis) Clinical significantly renal disorders Creatinine clearance < 60ml/min (0.84ml/s/㎡) or Glomerular filtration rate(eGFR) < 60mL/min/1.73 Severe gastrointestinal disorder Uncontrolled hypertension (SBP >180 mmHg or DBP > 110 mmHg) History of Acute coronary syndrome, unstable angina, myocardial infarction requiring hospitalization, stroke, transient ischemic attack, severe heart failure (NYHA class III/IV), or heart arrhythmia

Ages Eligible for Study
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Minimum Age: 20 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 tablets<br>Drug: Placebo<br>* DWP16001 placebo-matching tablets<br>|
| Experimental: DWP16001 Bmg<br>DWP16001 Bmg, Tablets, Orally, Once daily | Drug: DWP16001<br>* DWP16001 tablets<br>Drug: Placebo<br>* DWP16001 placebo-matching tablets<br>|
| Experimental: DWP16001 Cmg<br>DWP16001 Cmg, Tablets, Orally, Once daily | Drug: DWP16001<br>* DWP16001 tablets<br>Drug: Placebo<br>* DWP16001 placebo-matching tablets<br>|
| Placebo Comparator: Placebo<br>Placebo, Tablets, Orally, Once daily | Drug: Placebo<br>* DWP16001 placebo-matching tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c |  | at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in FPG |  | at week 4, 8, 12 | 
| The proportion of patients who achieve HbA1c < 7.0%, HbA1c < 6.5% and HbA1c reduction >0.5% from baseline |  | at week 4, 8, 12 |