The Efficacy and Safety of DWP16001 Compared to Placebo in the Treatment of Type 2 Diabetes Mellitus.
A Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2020
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2020
CompletedFirst Submitted
Initial submission to the registry
November 12, 2020
CompletedFirst Posted
Study publicly available on registry
November 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2021
CompletedOctober 25, 2022
October 1, 2022
1 year
November 12, 2020
October 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c level at Week 24 after administration of the IP
1.Change from Visit 2 (randomization) in HbA1c level at Week 24 after administration of the IP
at Week 24
Secondary Outcomes (3)
HbA1c level at Weeks 6, 12, and 18 after administration of the IP
at weeks 6, 12, and 18
FPG level at Weeks 6, 12, 18, and 24 after administration of the IP
at weeks 6, 12, 18, and 24
HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP
at weeks 6, 12, 18, and 24
Study Arms (2)
DWP16001 Amg
EXPERIMENTALDWP16001 Amg, Tablets, Orally, Once daily
DWP16001 Amg Placebo
PLACEBO COMPARATORDWP16001 Amg Placebo, Tablets, Orally, Once daily
Interventions
Eligibility Criteria
You may qualify if:
- Adults aged 19 to 80 years
- Subjects with 7% ≤ HbA1c ≤ 10% who have been diagnosed with T2DM at least 8 weeks
- Subjects with BMI of 20-45 kg/m2
- Subjects who have been on a stable diet and exercise program for at least 8 weeks
- Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Daewoong pharmatceutical
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2020
First Posted
November 17, 2020
Study Start
November 11, 2020
Primary Completion
November 25, 2021
Study Completion
November 25, 2021
Last Updated
October 25, 2022
Record last verified: 2022-10