NCT04654390CompletedPhase 3
A Multi-center, Randomized, Double-Blind, Active-controlled, Phase3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
Daewoong Pharmaceutical Co. LTD.1 site in 1 country270 target enrollmentStarted: December 30, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 270
- Locations
- 1
- Primary Endpoint
- Change from Visit 2(Randomization) in HbA1c level at Week 24 after administation of the IP
Study Overview
Brief Summary
The purpose of this study is to determine the efficacy and safety of DWP16001 compared to active drug in the treatment of type 2 diabetes mellitus.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 19 to 80 years
- •Subjects with 7% ≤ HbA1c ≤ 11% at Screening
- •Subjects with BMI of 20-45 kg/m2
Exclusion Criteria
- •Different type of diabetes mellitus which is not T2DM (type 1 diabetes mellitus, secondary diabetes mellitus, or congenital renal glucosuria)
- •Symptoms of stress urinary incontinence, dysuria that is not controlled by medications due to neurogenic bladder or prostatic hyperplasia, anuria, oliguria, or urinary retention
- •Severe diabetes complications (proliferative diabetic retinopathy, nephropathy of stage 4 or higher, or serious diabetic neuropathy)
- •eGFR < 60 mL/min/1.73 m2
- •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.
- •Uncontrolled hypertension (SBP >180 mmHg or DBP > 110 mmHg)
Arms & Interventions
DWP16001 Amg, Dapagiflozin Bmg placebo
Experimental
Tablets, Orally, Once daily
Intervention: DWP16001 Amg (Drug)
DWP16001 Amg placebo, Dapagliflozin Bmg
Active Comparator
Tablets, Orally, Once daily
Intervention: DWP16001 Amg (Drug)
Outcomes
Primary Outcomes
Change from Visit 2(Randomization) in HbA1c level at Week 24 after administation of the IP
Time Frame: at Week 24
HbA1c level at Week 24 after administration of the IP
Secondary Outcomes
- Changes from Visit 2 (randomization) in FPG level at Weeks 6, 12, 18, and 24 after administration of the IP(at weeks 6, 12, 18, and 24)
- Changes from Visit 2 (randomization) in HbA1c level at Weeks 6, 12, and 18 after administration of the IP(at weeks 6, 12, and 18)
- Proportions of subjects who achieved HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP(at weeks 6, 12, 18, and 24)
Investigators
Study Sites (1)
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