T2DM (Type 2 Diabetes Mellitus)
Conditions
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.
Interventions
DRUGPlacebo
DWP16001 placebo-matching tablets
DRUGDWP16001
DWP16001 tablets
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c | at 12 weeks |
Secondary
| Measure | 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 |
Countries
South Korea
Contacts
Primary ContactChoi
Backup ContactHyun
Outcome results
None listed