Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT04014023
Last Updated: 2019-07-18
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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UNKNOWN
PHASE2
196 participants
INTERVENTIONAL
2019-07-10
2020-06-30
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 tablets
Placebo
DWP16001 placebo-matching tablets
DWP16001 Bmg
DWP16001 Bmg, Tablets, Orally, Once daily
DWP16001
DWP16001 tablets
Placebo
DWP16001 placebo-matching tablets
DWP16001 Cmg
DWP16001 Cmg, Tablets, Orally, Once daily
DWP16001
DWP16001 tablets
Placebo
DWP16001 placebo-matching tablets
Placebo
Placebo, Tablets, Orally, Once daily
Placebo
DWP16001 placebo-matching tablets
Interventions
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DWP16001
DWP16001 tablets
Placebo
DWP16001 placebo-matching tablets
Eligibility Criteria
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Inclusion Criteria
* Patients who was diagnosed with type 2 diabetes mellitus at least 8 weeks before
* Body Mass Index (BMI) between 20 and 45 kg/㎡
* Patients with 7% ≤ HbA1c ≤ 10% at screening
* Subject who has conducted a stable diet and exercise for at least 8 weeks
Exclusion Criteria
* Severe diabetes complications (proliferative diabetic retinopathy, stage 4 or higher nephropathy or severe diabetic neuropathy, diabetic ketoacidosis)
* Clinical significantly renal disorders
* Creatinine clearance \< 60ml/min (0.84ml/s/㎡) or Glomerular filtration rate(eGFR) \< 60mL/min/1.73
* Severe gastrointestinal disorder
* Uncontrolled hypertension (SBP \>180 mmHg or DBP \> 110 mmHg)
* History of Acute coronary syndrome, unstable angina, myocardial infarction requiring hospitalization, stroke, transient ischemic attack, severe heart failure (NYHA class III/IV), or heart arrhythmia
20 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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Central Contacts
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Other Identifiers
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DWP16001201
Identifier Type: -
Identifier Source: org_study_id
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