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

Primary Purpose

Diabetes Mellitus, Type 2, Renal Disease, Diabetes Mellitus

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Evogliptin 5mg/Metformin 1000mg

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Suncheonhyang Bucheon Hospital
Se-jong hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group A

Arm Description

Patients receive Evogliptin 5mg/Metformin 1000mg once a day

Outcomes

Primary Outcome Measures

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?

Secondary Outcome Measures

Change from baseline in HbA1c (%) After 12 weeks

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

Change from baseline in Glycated albumin After 12 weeks

Change from baseline in e-GFR After 12 weeks

Change from baseline in UACR After 12 weeks

Urine Albumin-to-Creatinin Ratio

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

N-Acetyl-Glucosaminidase

Change from baseline in Nephrin After 12 weeks

Change from baseline in Cystatin-C After 12 weeks

TSQM-9 scores

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

Full Information

NCT ID

NCT04653779

First Posted

November 19, 2020

Last Updated

December 10, 2020

Sponsor

Dong-A ST Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 2020 (Anticipated)

Primary Completion Date

May 2021 (Anticipated)

Study Completion Date

July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dong-A ST Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Patients receive Evogliptin 5mg/Metformin 1000mg once a day

Intervention Type

Drug

Intervention Name(s)

Evogliptin 5mg/Metformin 1000mg

Other Intervention Name(s)

SUGAMET®XR tablet 5/1000mg

Intervention Description

Size reduction of a tablet formulation

Primary Outcome Measure Information:

Title

The preference regarding convenience of medication

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in HbA1c (%) After 12 weeks

Time Frame

12 weeks

Title

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

Time Frame

12 weeks

Title

Change from baseline in Glycated albumin After 12 weeks

Time Frame

12 weeks

Title

Change from baseline in e-GFR After 12 weeks

Time Frame

12 weeks

Title

Change from baseline in UACR After 12 weeks

Description

Urine Albumin-to-Creatinin Ratio

Time Frame

12 weeks

Title

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

Description

N-Acetyl-Glucosaminidase

Time Frame

12 weeks

Title

Change from baseline in Nephrin After 12 weeks

Time Frame

12 weeks

Title

Change from baseline in Cystatin-C After 12 weeks

Time Frame

12 weeks

Title

TSQM-9 scores

Description

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

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sung

Phone

82-2-920-8369

jhsung@donga.co.kr

Facility Information:

Facility Name

Suncheonhyang Bucheon Hospital

City

Bucheon

State/Province

Gyeonggi

ZIP/Postal Code

14584

Country

Korea, Republic of

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Suncheonhyang Bucheon Hospital

Phone

82-32-621-6363

irb@schmc.ac.kr

First Name & Middle Initial & Last Name & Degree

Bo Yeon Kim, MD

Facility Name

Se-jong hospital

City

Bucheon

State/Province

Gyeonggi

ZIP/Postal Code

14754

Country

Korea, Republic of

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Se-jong hospital

Phone

82-32-340-1236

First Name & Middle Initial & Last Name & Degree

Chong Hwa Kim, MD

12. IPD Sharing Statement

Learn more about this trial

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

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