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

Phase 4

• Conditions: Metabolic Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2; Renal Disease; Endocrine System Diseases
• Interventions: Drug: Evogliptin 5mg/Metformin 1000mg

• Registration Number: NCT04653779
• Lead Sponsor: Dong-A ST Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-11-27
• Status Verified: 2020-12
• Study Start: 2020-12
• Study First Posted: 2020-12-04
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-11
• Primary Completion: 2021-05
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A	Evogliptin 5mg/Metformin 1000mg	Patients receive Evogliptin 5mg/Metformin 1000mg once a day

Primary Outcome Measures

Name	Time	Method
The preference regarding convenience of medication	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?

Secondary Outcome Measures

Name	Time	Method
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	12 weeks	Urine Albumin-to-Creatinin Ratio
Change from baseline in HbA1c (%) After 12 weeks NAG	12 weeks	N-Acetyl-Glucosaminidase
Change from baseline in Nephrin After 12 weeks	12 weeks
Change from baseline in Cystatin-C After 12 weeks	12 weeks
TSQM-9 scores	12 weeks	Treatment Satisfaction Questionnaire for Medication-9 scores, higher scores mean a better outcome.

Trial Locations

Locations (2)

Suncheonhyang Bucheon Hospital; 🇰🇷 Bucheon, Gyeonggi, Korea, Republic of

Se-jong hospital; 🇰🇷 Bucheon, Gyeonggi, Korea, Republic of