Status:
UNKNOWN
Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
T2DM (Type 2 Diabetes Mellitus)
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT04014023
Start Date
July 10 2019
End Date
June 1 2020
Last Update
July 18 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Daewoong pharmatceutical
Seoul, South Korea