Study to Evaluate the Long Term Safety and Efficacy of DWP16001 Compared to Placebo in the Treatment of T2DM.

NCT ID: NCT05376930

Last Updated: 2022-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-16

Study Completion Date

2022-05-31

Brief Summary

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The purpose of this study is evaluate the long term safety and efficacy of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.

Detailed Description

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Conditions

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T2DM (Type 2 Diabetes Mellitus)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DWP16001

DWP16001 Tablets

Group Type EXPERIMENTAL

DWP16001 Amg

Intervention Type DRUG

DWP16001 Amg, Tablets, Orally, Once daily

Interventions

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DWP16001 Amg

DWP16001 Amg, Tablets, Orally, Once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

2. Voluntarily decided to participate in the extension study and provided a written consent on the consent form

Exclusion Criteria

1. Those who dropped out of the previously conducted phase 3 clinical trial (Protocol No: DW\_DWP16001301)
2. Pregnant or lactating women or those who do not consent to the use of appropriate contraceptive methods during clinical trials Appropriate method of birth control for you or your partner: You must agree to one of the following

* Either surgical sterilization (vasectomy, etc.) or insertion of an intrauterine device (copper loop, intrauterine hormone-containing system), or
* A physical barrier method combined with either systemic hormonal contraceptives or spermicide, or
* Use of male condom combined with either cervical cap or diaphragm
3. In case the investigator judges that participation in this extended clinical trial is inappropriate in consideration of the 24-week observation progress in the previously conducted phase 3 clinical trial (Protocol No: DW\_DWP16001301)
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Daewoong pharmatceutical

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW_DWP16001301_Ext

Identifier Type: -

Identifier Source: org_study_id

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