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

Daewoong Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

T2DM (Type 2 Diabetes Mellitus)

Treatments

Drug: DWP16001 Amg

Study type

Interventional

Funder types

Industry

Identifiers

DW_DWP16001301_Ext

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participated in the prior phase 3 study (Protocol No: DW_DWP16001301) 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

Those who dropped out of the previously conducted phase 3 clinical trial (Protocol No: DW_DWP16001301)
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
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)