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

A Multi-center, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05376930

Enrollment

Registered

2022-05-17

Start date

2021-09-16

Completion date

2022-05-31

Last updated

2022-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T2DM (Type 2 Diabetes Mellitus)

Brief summary

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.

Interventions

DRUGDWP16001 Amg

DWP16001 Amg, Tablets, Orally, Once daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Participated in the prior phase 3 study (Protocol No: DW\_DWP16001301) for meeting the inclusion criteria and completed the study 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)

Design outcomes

Primary

Measure	Time frame	Description
Changes from baseline in Adverse events (AEs) and adverse events of special interest (AESIs)* at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP	at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP	\*Hypoglycemia, urinary tract infection, genital infection, pollakiuria, or polyuria

Secondary

Measure	Time frame	Description
Changes from baseline* in HbA1c at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP	at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP	\* Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW\_DWP16001301)
Changes from baseline* in FPG at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP	at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP	\* Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW\_DWP16001301)
Proportion of subjects achieving HbA1c target of < 7% at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP	at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP	\* Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW\_DWP16001301)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026