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

December 10, 2020 updated by: Dong-A ST Co., Ltd.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Bucheon, Gyeonggi, Korea, Republic of, 14584
        • Suncheonhyang Bucheon Hospital
      • Bucheon, Gyeonggi, Korea, Republic of, 14754
        • Se-jong hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Patients receive Evogliptin 5mg/Metformin 1000mg once a day
Drug: Evogliptin 5mg/Metformin 1000mg
Size reduction of a tablet formulation
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
12 weeks
Change from baseline in HbA1C response rate(%) After 12 weeks
Time Frame: 12 weeks
12 weeks
Change from baseline in Glycated albumin After 12 weeks
Time Frame: 12 weeks
12 weeks
Change from baseline in e-GFR After 12 weeks
Time Frame: 12 weeks
12 weeks
Change from baseline in UACR After 12 weeks
Time Frame: 12 weeks
Urine Albumin-to-Creatinin Ratio
12 weeks
Change from baseline in HbA1c (%) After 12 weeks NAG
Time Frame: 12 weeks
N-Acetyl-Glucosaminidase
12 weeks
Change from baseline in Nephrin After 12 weeks
Time Frame: 12 weeks
12 weeks
Change from baseline in Cystatin-C After 12 weeks
Time Frame: 12 weeks
12 weeks
TSQM-9 scores
Time Frame: 12 weeks
Treatment Satisfaction Questionnaire for Medication-9 scores, higher scores mean a better outcome.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

November 19, 2020

First Submitted That Met QC Criteria

November 27, 2020

First Posted (Actual)

December 4, 2020

Study Record Updates

Last Update Posted (Actual)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA1229_01_DM_IV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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