Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
A Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase 2, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
1 other identifier
interventional
196
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 P75+ for phase_2
Started Jul 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2019
CompletedFirst Posted
Study publicly available on registry
July 10, 2019
CompletedStudy Start
First participant enrolled
July 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJuly 18, 2019
July 1, 2019
8 months
July 7, 2019
July 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in HbA1c
at 12 weeks
Secondary Outcomes (2)
Change from baseline in FPG
at week 4, 8, 12
The proportion of patients who achieve HbA1c < 7.0%, HbA1c < 6.5% and HbA1c reduction >0.5% from baseline
at week 4, 8, 12
Study Arms (4)
DWP16001 Amg
EXPERIMENTALDWP16001 Amg, Tablets, Orally, Once daily
DWP16001 Bmg
EXPERIMENTALDWP16001 Bmg, Tablets, Orally, Once daily
DWP16001 Cmg
EXPERIMENTALDWP16001 Cmg, Tablets, Orally, Once daily
Placebo
PLACEBO COMPARATORPlacebo, Tablets, Orally, Once daily
Interventions
Eligibility Criteria
You may qualify if:
- Patients aged 20 to 80 years
- 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
You may not qualify if:
- Type 1 diabetes mellitus or secondary diabetes
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Daewoong pharmatceutical
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2019
First Posted
July 10, 2019
Study Start
July 10, 2019
Primary Completion
March 1, 2020
Study Completion
June 1, 2020
Last Updated
July 18, 2019
Record last verified: 2019-07