Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With T2DM Inadequately Controlled on Metformin

T2DM (Type 2 Diabetes Mellitus) Clinical Trial

— ENHANCE-MEXT  

Official title:

A Multi-center, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05376969
• Other study ID #: DW_DWP16001302_Ext
• Status: Completed
• Phase: Phase 3
• Start date: May 25, 2021
• Est. completion date: May 16, 2022

Study information

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

Clinical Trial Summary

A Multi-center, Open-label, Extension study to Evaluate the long term Safety and Efficacy of DWP16001 add-on to metformin in Patients with type 2 diabetes mellitus inadequately controlled on metformin

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: May 16, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Participated in the prior phase 3 study (Protocol No: DW_DWP16001302) for meeting the inclusion criteria and completed the study

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

Exclusion Criteria:

• Withdrawn from the prior phase 3 study (Protocol No: DW_DWP16001302) or expected of having safety issue if taking part in the study in the judgment of the investigator

• Subjects with the following diseases or signs:

• Diabetic ketoacidosis

• Moderate to severe renal impairment (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73 m2

• Females who are pregnant or breast-feeding, or subjects who do not agree to the use of appropriate contraceptive methods throughout the study

Subjects must agree to one of the following appropriate contraceptive methods for subjects or their partners:

? 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 Determined to be ineligible for the study by the investigator, besides the above

Related Conditions & MeSH terms

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

Intervention

Drug:
• DWP16001
DWP16001 Tablets

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_DWP16001302)	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_DWP16001302)	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_DWP16001302)	at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP