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

Study Overview
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Brief Summary
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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

Official Title
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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
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T2DM (Type 2 Diabetes Mellitus)

Intervention / Treatment
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* Drug: DWP16001


Participation Criteria
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Eligibility Criteria
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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decided to participate in the extension study and provided a written consent on the consent form Exclusion Criteria: Withdrawn from the prior phase 3 study (Protocol No: DW_DWP16001302) or expected of having safety issue if taking part in the study in the judgment of the investigator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: 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

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 Amg<br>DWP16001 Amg, Tablets, Orally, Once daily | Drug: DWP16001<br>* DWP16001 Tablets<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_DWP16001302) | 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_DWP16001302) | 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_DWP16001302) | at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP |