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

Phase 3

Completed

• Conditions: T2DM (Type 2 Diabetes Mellitus)
• Interventions: Drug: DWP16001 Amg

• Registration Number: NCT05376930
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-16
• Status Verified: 2022-01
• Study First Submitted: 2022-01-09
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-17
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Last Update Submitted: 2022-10-23
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DWP16001	DWP16001 Amg	DWP16001 Tablets

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)

Trial Locations

Locations (1)

Daewoong pharmatceutical; 🇰🇷 Seoul, Korea, Republic of