The Efficacy and Safety of DWP16001 Compared to Placebo in the Treatment of Type 2 Diabetes Mellitus.
NCT ID: NCT04632862
Last Updated: 2022-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
140 participants
INTERVENTIONAL
2020-11-11
2021-11-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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DWP16001 Amg
DWP16001 Amg, Tablets, Orally, Once daily
DWP16001
DWP16001 A mg
DWP16001 Amg Placebo
DWP16001 Amg Placebo, Tablets, Orally, Once daily
DWP16001
DWP16001 A mg
Interventions
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DWP16001
DWP16001 A mg
Eligibility Criteria
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Inclusion Criteria
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
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)
19 Years
80 Years
ALL
No
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
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Locations
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Daewoong pharmatceutical
Seoul, , South Korea
Countries
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Other Identifiers
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DW_DWP16001301
Identifier Type: -
Identifier Source: org_study_id
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