search
Back to results

To Evaluate the Efficacy and Safety of JW0201 Added on in Patients With Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Treatment Period(JW0201)
Treatment Period(Placebo)
Extension Period(JW0201)
Sponsored by
JW Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Type 2 Diabetes Mellitus Exclusion Criteria: Type 1 Diabetes Mellitus The subject not meet the specified HbA1c and FPG

Sites / Locations

  • Kangbuk Samsung HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

JW0201+C2202+C2203

C2202+C2203

Arm Description

Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks)

Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks)

Outcomes

Primary Outcome Measures

HbA1c (24 Weeks) lowering effect
change in HbA1c

Secondary Outcome Measures

HbA1c lowering effect
change in HbA1c

Full Information

First Posted
April 3, 2023
Last Updated
May 1, 2023
Sponsor
JW Pharmaceutical
search

1. Study Identification

Unique Protocol Identification Number
NCT05814393
Brief Title
To Evaluate the Efficacy and Safety of JW0201 Added on in Patients With Type 2 Diabetes Mellitus
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of JW0201 Added on in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With C2202 and C2203
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JW Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A multicenter, randomized, double-blind, placebo-controlled, parallel, phase Ⅲ study to evaluate the efficacy and safety of JW0201 added on in patients with type 2 diabetes mellitus who have inadequate glycemic control with C2202 and C2203
Detailed Description
A multicenter, randomized, double-blind, placebo-controlled, parallel, phase Ⅲ study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JW0201+C2202+C2203
Arm Type
Experimental
Arm Description
Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks)
Arm Title
C2202+C2203
Arm Type
Placebo Comparator
Arm Description
Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks)
Intervention Type
Drug
Intervention Name(s)
Treatment Period(JW0201)
Other Intervention Name(s)
JW0201+C2022+C2203
Intervention Description
JW0201: 200mg/day For 24 weeks(PO, BID) C2022: ≥1,000 mg/day for 24 Weeks(PO, BID) C2203: 25 mg/day for 24 Weeks(PO, BID)
Intervention Type
Drug
Intervention Name(s)
Treatment Period(Placebo)
Other Intervention Name(s)
C2022+C2203
Intervention Description
C2022: ≥1,000 mg/day for 24 Weeks(PO, BID) C2203: 25 mg/day for 24 Weeks(PO, BID)
Intervention Type
Drug
Intervention Name(s)
Extension Period(JW0201)
Other Intervention Name(s)
JW0201+C2022+C2203
Intervention Description
JW0201: 200mg/day For 28 weeks(PO, BID) C2022: ≥1,000 mg/day for 28 Weeks(PO, BID) C2203: 25 mg/day for 28 Weeks(PO, BID)
Primary Outcome Measure Information:
Title
HbA1c (24 Weeks) lowering effect
Description
change in HbA1c
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
HbA1c lowering effect
Description
change in HbA1c
Time Frame
6, 12, 18, 32, 40, 52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 Diabetes Mellitus Exclusion Criteria: Type 1 Diabetes Mellitus The subject not meet the specified HbA1c and FPG
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siyoung Heo
Phone
+82-2-840-6811
Email
20190291@jw-group.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Dongryeong Lee
Phone
+82-2-840-6982
Email
dongryung.lee@jw-pharma.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheol-Young Park
Organizational Affiliation
Kangbuk Samsung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kangbuk Samsung Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheol-Young Park

12. IPD Sharing Statement

Learn more about this trial

To Evaluate the Efficacy and Safety of JW0201 Added on in Patients With Type 2 Diabetes Mellitus

We'll reach out to this number within 24 hrs