A Clinical Trial to Evaluate the Preference Regarding Convenience of Medication and Efficacy/Safety of SUGAMET®XR Tablet 5/1000mg

Study Overview
=================
Brief Summary
-----------------
Multi-center, open-label, single arm study to Evaluate the preference regarding convenience of medication, efficacy and safety of Sugamet XR tab. 5/1000mg in patients with Type 2 diabetes and renal diseases

Official Title
-----------------
A Multi-center, Open-label, Single-arm, Phase IV Clinical Trial to Evaluate the Preference Regarding Convenience of Medication, Efficacy and Safety After Switching to SUGAMET®XR Tablet 5/1000mg in Patients With Type 2 Diabetes and Renal Diseases

Conditions
-----------------
Renal Disease, Diabetes Mellitus, Type 2, Diabetes Mellitus, Metabolic Disease, Endocrine System Diseases

Intervention / Treatment
-----------------
* Drug: Evogliptin 5mg/Metformin 1000mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥60 years Subjects with type 2 diabetes mellitus Subjects treated with DPP-4 inhibitor and 1,000mg/day dose of metformin 1T/qd for at least 8 weeks prior to screening Subjects with HbA1c≤7.5% at screening Subjects with 45mL/min/1.73m2≤eGFR≤90mL/min/1.73m2 at screening Subjects with fasting glucose≤200 at screening Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening Exclusion Criteria: Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus ESRD or Patients who have kidney dialysis Subjects with ALT and AST 3 times or higher than upper normal range

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Patients receive Evogliptin 5mg/Metformin 1000mg once a day | Drug: Evogliptin 5mg/Metformin 1000mg<br>* Size reduction of a tablet formulation<br>* Other names: SUGAMET®XR tablet 5/1000mg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The preference regarding convenience of medication | Looking back on the experience of participating in the study, which would you prefer, any of the existing DPP-4 inhibitor/metformin 1000mg sustained-release combination drug or the SugarMet® sustained-release tablet 5/1000mg? | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c (%) After 12 weeks |  | 12 weeks | 
| Change from baseline in HbA1C response rate(%) After 12 weeks |  | 12 weeks | 
| Change from baseline in Glycated albumin After 12 weeks |  | 12 weeks | 
| Change from baseline in e-GFR After 12 weeks |  | 12 weeks | 
| Change from baseline in UACR After 12 weeks | Urine Albumin-to-Creatinin Ratio | 12 weeks | 
| Change from baseline in HbA1c (%) After 12 weeks NAG | N-Acetyl-Glucosaminidase | 12 weeks | 
| Change from baseline in Nephrin After 12 weeks |  | 12 weeks | 
| Change from baseline in Cystatin-C After 12 weeks |  | 12 weeks | 
| TSQM-9 scores | Treatment Satisfaction Questionnaire for Medication-9 scores, higher scores mean a better outcome. | 12 weeks |