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
DRUGDWP16001
DWP16001 A mg
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. Adults aged 19 to 80 years 2. Subjects with 7% ≤ HbA1c ≤ 10% who have been diagnosed with T2DM at least 8 weeks 3. Subjects with BMI of 20-45 kg/m2 4. Subjects who have been on a stable diet and exercise program for at least 8 weeks 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. Different type of diabetes mellitus which is not T2DM (type 1 diabetes mellitus, secondary diabetes mellitus, or congenital renal glucosuria) 2. Symptoms of stress urinary incontinence, dysuria that is not controlled by medications due to neurogenic bladder or prostatic hyperplasia, anuria, oliguria, or urinary retention 3. Severe diabetes complications (proliferative diabetic retinopathy, nephropathy of stage 4 or higher, or serious diabetic neuropathy) 4. eGFR \< 60 mL/min/1.73 m2 5. Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc. 6. Uncontrolled hypertension (SBP \>180 mmHg or DBP \> 110 mmHg)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c level at Week 24 after administration of the IP | at Week 24 | 1.Change from Visit 2 (randomization) in HbA1c level at Week 24 after administration of the IP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c level at Weeks 6, 12, and 18 after administration of the IP | at weeks 6, 12, and 18 | 1.Changes from Visit 2 (randomization) in HbA1c level at Weeks 6, 12, and 18 after administration of the IP |
| FPG level at Weeks 6, 12, 18, and 24 after administration of the IP | at weeks 6, 12, 18, and 24 | 2.Changes from Visit 2 (randomization) in FPG level at Weeks 6, 12, 18, and 24 after administration of the IP |
| HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP | at weeks 6, 12, 18, and 24 | 3.Proportions of subjects who achieved HbA1c level \< 7% at Weeks 6, 12, 18, and 24 after administration of the IP |
Countries
South Korea
Outcome results
None listed