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

NCT ID: NCT05376969

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-25
• Study Completion Date: 2022-05-16

Brief 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

Conditions

T2DM (Type 2 Diabetes Mellitus)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DWP16001 Amg

DWP16001 Amg, Tablets, Orally, Once daily

Group Type: EXPERIMENTAL

DWP16001

Intervention Type: DRUG

DWP16001 Tablets

Interventions

DWP16001

DWP16001 Tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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• Withdrawn from the prior phase 3 study (Protocol No: DW_DWP16001302) or expected of having safety issue if taking part in the study in the judgment of the investigator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

① Either surgical sterilization (vasectomy, etc.) or insertion of an intrauterine device (copper loop, intrauterine hormone-containing system), or

② A physical barrier method combined with either systemic hormonal contraceptives or spermicide, or

③ Use of male condom combined with either cervical cap or diaphragm Determined to be ineligible for the study by the investigator, besides the above

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Daewoong pharmatceutical

Seoul, , South Korea

Countries

South Korea

Other Identifiers

DW_DWP16001302_Ext

Identifier Type: -

Identifier Source: org_study_id