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

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

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.

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