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

• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05376930
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 8.5
• Patients Per Site Per Month: 7.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
T2DM (Type 2 Diabetes Mellitus)	Drug: DWP16001 Amg	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-center, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus
• Actual Study Start Date: Sep 16, 2021
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DWP16001 DWP16001 Tablets	Drug: DWP16001 Amg; DWP16001 Amg, Tablets, Orally, Once daily

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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)

3. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Daewoong pharmatceutical	Seoul		Korea, Republic of

Sponsors and Collaborators

• Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daewoong Pharmaceutical Co. LTD.
• ClinicalTrials.gov Identifier: NCT05376930
• Other Study ID Numbers: DW_DWP16001301_Ext
• First Posted: May 17, 2022
• Last Update Posted: May 17, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of May 17, 2022