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

Dong-A ST Co., Ltd.54 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Evogliptin 5mg/Metformin 1000mgDRUG

Size reduction of a tablet formulation

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

Suncheonhyang Bucheon Hospital

Bucheon-si, Gyeonggi-do, South Korea

Se-jong hospital

Bucheon-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

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?

Time frame: 12 weeks

Secondary Outcomes

Change from baseline in HbA1c (%) After 12 weeks

Time frame: 12 weeks

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

Time frame: 12 weeks

Change from baseline in Glycated albumin After 12 weeks

Time frame: 12 weeks

Change from baseline in e-GFR After 12 weeks

Time frame: 12 weeks

Change from baseline in UACR After 12 weeks

Urine Albumin-to-Creatinin Ratio

Time frame: 12 weeks

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

N-Acetyl-Glucosaminidase

Time frame: 12 weeks

Change from baseline in Nephrin After 12 weeks

Time frame: 12 weeks

Change from baseline in Cystatin-C After 12 weeks

Time frame: 12 weeks

TSQM-9 scores

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

Central Contacts

Sung

CONTACT

82-2-920-8369 jhsung@donga.co.kr

Data from ClinicalTrials.gov

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