T2DM (Type 2 Diabetes Mellitus)
Conditions
Brief summary
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.
Detailed description
A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.
Interventions
DRUGDapagliflozin
Dapagliflozin Tablet
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects with T2DM aged 19 to 80 years 2. Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ HbA1c ≤ 10.5% 3. Subjects with BMI of 20-45 kg/m2 4. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study
Exclusion criteria
1. Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors) 2. Diabetic ketoacidosis, diabetic coma or precoma within the past year 3. Urinary tract infections or genital infections within 4. Uncontrolled hypertension (SBP \> 180 mmHg or DBP \> 110 mmHg) 5. eGFR \< 60 mL/min/1.73 m2 6. Severe heart failure (NYHA class III/IV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c | at 24 weeks |
Countries
South Korea
Outcome results
None listed