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

• Status: Unknown status
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Criteria

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