T2DM (Type 2 Diabetes Mellitus)
Conditions
Brief summary
The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period. At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial. The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.
Detailed description
The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period. Throughout this period, subjects will receive concurrent administration of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day), and will have a washout period for other oral antidiabetic drugs. At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial. The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.
Interventions
DRUGDWP16001 0.3 mg
DWP16001 0.3mg, Tablets, Orally, Once daily
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects with T2DM age 19 \ under 80 years 2. Subjects who have 7% ≤ HbA1c ≤ 11% in screening visit(V1-1) 3. Subjects who have FPG \<270 mg/dl screening visit(V1-1) 4. Subjects who have received a combination of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day) for a minimum of 8 weeks prior to Visit 2 (Enrollment Visit) 5. 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 \< 45 mL/min/1.73 m2 6. Severe heart failure (NYHA class III/IV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety outcomes_Adverse events occurred during clinical trials | from baseline up to 52 weeks | Safety outcomes\_Adverse events occurred during clinical trials |
| Safety outcomes_ Change of blood pressure | from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP | Safety outcomes\_ Change of blood pressure |
| Safety outcomes_ Change of heartbeat | from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP | Safety outcomes\_ Change of heartbeat |
| Safety outcomes_ Change of body temperature | from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP | Safety outcomes\_ Change of body temperature |
| Efficacy outcome_Change of HbA1c | from Baseline at Week 8, 16, 24, 38, and 52 after administration of the IP | Efficacy outcome\_Change of HbA1c |
| Efficacy outcome_Change of FPG | from baseline at Week 8, 16, 24, 38, and 52 after administration of the IP | Efficacy outcome\_Change of FPG |
| Efficacy outcome_Proportion of subjects achieving HbA1c target of < 6.5% | at Weeks 8, 16, 24, 38 and 52 after administration of the IP | Efficacy outcome\_Proportion of subjects achieving HbA1c target of \< 6.5% |
| Efficacy outcome_Proportion of subjects achieving HbA1c target of < 7.0 % | at Weeks 8, 16, 24, 38 and 52 after administration of the IP | Efficacy outcome\_Proportion of subjects achieving HbA1c target of \< 6.5% |
Contacts
Primary ContactJayoung Shon
Outcome results
None listed