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

T2DM (Type 2 Diabetes Mellitus) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05376930
• Other study ID #: DW_DWP16001301_Ext
• Status: Completed
• Phase: Phase 3
• Start date: September 16, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: January 2022
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• T2DM (Type 2 Diabetes Mellitus)

Intervention

Drug:
• DWP16001 Amg
DWP16001 Amg, Tablets, Orally, Once daily

Locations

Country	Name	City	State
Korea, Republic of	Daewoong pharmatceutical	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	*Hypoglycemia, urinary tract infection, genital infection, pollakiuria, or polyuria	at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Secondary	Changes from baseline* in HbA1c 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)	at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Secondary	Changes from baseline* in FPG 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)	at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Secondary	Proportion of subjects achieving HbA1c target of < 7% 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)	at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP