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

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-center, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus

Conditions
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T2DM (Type 2 Diabetes Mellitus)

Intervention / Treatment
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* Drug: DWP16001 Amg


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWP16001<br>DWP16001 Tablets | Drug: DWP16001 Amg<br>* DWP16001 Amg, Tablets, Orally, Once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |