Back to resultsStudy to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
Primary Purpose
T2DM (Type 2 Diabetes Mellitus)
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWP16001
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for T2DM (Type 2 Diabetes Mellitus)
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Daewoong pharmatceuticalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
DWP16001 Amg
DWP16001 Bmg
DWP16001 Cmg
Placebo
Arm Description
DWP16001 Amg, Tablets, Orally, Once daily
DWP16001 Bmg, Tablets, Orally, Once daily
DWP16001 Cmg, Tablets, Orally, Once daily
Placebo, Tablets, Orally, Once daily
Outcomes
Primary Outcome Measures
Change from baseline in HbA1c
Secondary Outcome Measures
Change from baseline in FPG
The proportion of patients who achieve HbA1c < 7.0%, HbA1c < 6.5% and HbA1c reduction >0.5% from baseline
Full Information
NCT ID
NCT04014023
First Posted
July 7, 2019
Last Updated
July 16, 2019
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT04014023
Brief Title
Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2019 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T2DM (Type 2 Diabetes Mellitus)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
196 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DWP16001 Amg
Arm Type
Experimental
Arm Description
DWP16001 Amg, Tablets, Orally, Once daily
Arm Title
DWP16001 Bmg
Arm Type
Experimental
Arm Description
DWP16001 Bmg, Tablets, Orally, Once daily
Arm Title
DWP16001 Cmg
Arm Type
Experimental
Arm Description
DWP16001 Cmg, Tablets, Orally, Once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, Tablets, Orally, Once daily
Intervention Type
Drug
Intervention Name(s)
DWP16001
Intervention Description
DWP16001 tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
DWP16001 placebo-matching tablets
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c
Time Frame
at 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in FPG
Time Frame
at week 4, 8, 12
Title
The proportion of patients who achieve HbA1c < 7.0%, HbA1c < 6.5% and HbA1c reduction >0.5% from baseline
Time Frame
at week 4, 8, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Choi
Email
jhchoi413@daewoong.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun
Email
wrhyun075@daewoong.co.kr
Facility Information:
Facility Name
Daewoong pharmatceutical
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
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