The Efficacy Nad Safety of DWP16001 Compared to Active Dr... | NCT04654390

Studies
The Efficacy Nad Safety of DWP16001 Compared to Active Drug in the Treatment of Type 2 Diabetes Mellitus

NCT04654390

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Completed

Last Update Posted

Apr 1, 2022Actual

Enrollment

270Actual

Phase

Phase 3

Conditions

T2DM (Type 2 Diabetes Mellitus)

Interventions

DWP16001 Amg

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 30, 2020Actual

Primary Completion Date

Dec 17, 2021Actual

Completion Date

Dec 17, 2021Actual

First Submitted Date

Nov 19, 2020

First Submission Date that Met QC Criteria

Dec 3, 2020

First Posted Date

Dec 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2022

Last Update Posted Date

Apr 1, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

270Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DWP16001 Amg, Dapagiflozin Bmg placebo	Experimental	Tablets, Orally, Once daily	Drug: DWP16001 Amg
DWP16001 Amg placebo, Dapagliflozin Bmg	Active Comparator	Tablets, Orally, Once daily	Drug: DWP16001 Amg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DWP16001 Amg	Drug	Tablets, Orally, Once daily	DWP16001 Amg placebo, Dapagliflozin Bmg DWP16001 Amg, Dapagiflozin Bmg placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Visit 2(Randomization) in HbA1c level at Week 24 after administation of the IP	HbA1c level at Week 24 after administration of the IP	at Week 24

Secondary Outcomes

Measure	Description	Time Frame
Changes from Visit 2 (randomization) in HbA1c level at Weeks 6, 12, and 18 after administration of the IP	HbA1c level at Weeks 6, 12, and 18 after administration of the IP	at weeks 6, 12, and 18
Changes from Visit 2 (randomization) in FPG level at Weeks 6, 12, 18, and 24 after administration of the IP

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sungrae KIm, MD, PhD	The Catholic University of Korea Bucheon St. Mary's Hospital, Republic of Korea	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Catholic University of Korea Bucheon St. Mary's Hospital, Republic of Korea		Bucheon-si			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

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Browse Branches

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