The Efficacy Nad Safety of DWP16001 Compared to Active Drug in the Treatment of Type 2 Diabetes Mellitus
NCT ID: NCT04654390
Last Updated: 2022-04-01
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
270 participants
INTERVENTIONAL
2020-12-30
2021-12-17
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, Dapagiflozin Bmg placebo
Tablets, Orally, Once daily
DWP16001 Amg
Tablets, Orally, Once daily
DWP16001 Amg placebo, Dapagliflozin Bmg
Tablets, Orally, Once daily
DWP16001 Amg
Tablets, Orally, Once daily
Interventions
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DWP16001 Amg
Tablets, Orally, Once daily
Eligibility Criteria
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Inclusion Criteria
2. Subjects with 7% ≤ HbA1c ≤ 11% at Screening
3. Subjects with BMI of 20-45 kg/m2
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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Principal Investigators
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Sungrae KIm, MD, PhD
Role: STUDY_DIRECTOR
The Catholic University of Korea Bucheon St. Mary's Hospital, Republic of Korea
Locations
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The Catholic University of Korea Bucheon St. Mary's Hospital, Republic of Korea
Bucheon-si, , South Korea
Countries
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Other Identifiers
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DW_DWP16001303
Identifier Type: -
Identifier Source: org_study_id
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