## Protocol Section
### Identification Module
**NCT ID:** NCT04653779

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

**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

#### Organization Study ID Info
**ID:** DA1229_01_DM_IV
#### Organization
**Class:** INDUSTRY
**Full Name:** Dong-A ST Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2021-07

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2020-12-11

**Type:** ACTUAL

**Last Update Submit Date:** 2020-12-10

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-12

**Type:** ESTIMATED

**Status Verified Date:** 2020-12

#### Study First Post Date
**Date:** 2020-12-04
**Type:** ACTUAL
**Study First Submit Date:** 2020-11-19
**Study First Submit QC Date:** 2020-11-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Dong-A ST Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Diabetes Mellitus, Type 2

- Renal Disease

- Diabetes Mellitus

- Metabolic Disease

- Endocrine System Diseases

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 54

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients receive Evogliptin 5mg/Metformin 1000mg once a day

**Intervention Names:**

- Drug: Evogliptin 5mg/Metformin 1000mg

**Label:** Group A

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A

**Description:** Size reduction of a tablet formulation

**Name:** Evogliptin 5mg/Metformin 1000mg

**Other Names:**

- SUGAMET®XR tablet 5/1000mg

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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?

**Measure:** The preference regarding convenience of medication

**Time Frame:** 12 weeks

#### Secondary Outcomes

**Measure:** Change from baseline in HbA1c (%) After 12 weeks

**Time Frame:** 12 weeks

**Measure:** Change from baseline in HbA1C response rate(%) After 12 weeks

**Time Frame:** 12 weeks

**Measure:** Change from baseline in Glycated albumin After 12 weeks

**Time Frame:** 12 weeks

**Measure:** Change from baseline in e-GFR After 12 weeks

**Time Frame:** 12 weeks

**Description:** Urine Albumin-to-Creatinin Ratio

**Measure:** Change from baseline in UACR After 12 weeks

**Time Frame:** 12 weeks

**Description:** N-Acetyl-Glucosaminidase

**Measure:** Change from baseline in HbA1c (%) After 12 weeks NAG

**Time Frame:** 12 weeks

**Measure:** Change from baseline in Nephrin After 12 weeks

**Time Frame:** 12 weeks

**Measure:** Change from baseline in Cystatin-C After 12 weeks

**Time Frame:** 12 weeks

**Description:** Treatment Satisfaction Questionnaire for Medication-9 scores, higher scores mean a better outcome.

**Measure:** TSQM-9 scores

**Time Frame:** 12 weeks

### Eligibility Module

**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

**Minimum Age:** 60 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jhsung@donga.co.kr

**Name:** Sung

**Phone:** 82-2-920-8369

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bucheon

**Contacts:**

***Contact 1:***

- **Email:** irb@schmc.ac.kr

- **Name:** Suncheonhyang Bucheon Hospital

- **Phone:** 82-32-621-6363

- **Role:** CONTACT

***Contact 2:***

- **Name:** Bo Yeon Kim, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Korea, Republic of

**Facility:** Suncheonhyang Bucheon Hospital

**State:** Gyeonggi

**Zip:** 14584

**Location 2:**

**City:** Bucheon

**Contacts:**

***Contact 1:***

- **Name:** Se-jong hospital

- **Phone:** 82-32-340-1236

- **Role:** CONTACT

***Contact 2:***

- **Name:** Chong Hwa Kim, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Korea, Republic of

**Facility:** Se-jong hospital

**State:** Gyeonggi

**Zip:** 14754

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Diabetes Mellitus, Type 2

- ID: M10698

- Name: Kidney Diseases

- Relevance: HIGH

- As Found: Renal Disease

- ID: M11639

- Name: Metabolic Diseases

- Relevance: HIGH

- As Found: Metabolic Diseases

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: HIGH

- As Found: Endocrine System Diseases

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007674

- Term: Kidney Diseases

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Intervention Browse Module - Ancestors

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11667

- Name: Metformin

- Relevance: HIGH

- As Found: Assessment

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008687

- Term: Metformin

### Misc Info Module

- Version Holder: 2024-05-24
