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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04653779
• Other study ID #: DA1229_01_DM_IV
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 2020
• Est. completion date: July 2021

Study information

• Verified date: December 2020
• Source: Dong-A ST Co., Ltd.
• Contact: Sung
• Phone: 82-2-920-8369
• Email: jhsung[@]donga.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: July 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Evogliptin 5mg/Metformin 1000mg
Size reduction of a tablet formulation

Locations

Country	Name	City	State
Korea, Republic of	Se-jong hospital	Bucheon	Gyeonggi
Korea, Republic of	Suncheonhyang Bucheon Hospital	Bucheon	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?	12 weeks
Secondary	Change from baseline in HbA1c (%) After 12 weeks		12 weeks
Secondary	Change from baseline in HbA1C response rate(%) After 12 weeks		12 weeks
Secondary	Change from baseline in Glycated albumin After 12 weeks		12 weeks
Secondary	Change from baseline in e-GFR After 12 weeks		12 weeks
Secondary	Change from baseline in UACR After 12 weeks	Urine Albumin-to-Creatinin Ratio	12 weeks
Secondary	Change from baseline in HbA1c (%) After 12 weeks NAG	N-Acetyl-Glucosaminidase	12 weeks
Secondary	Change from baseline in Nephrin After 12 weeks		12 weeks
Secondary	Change from baseline in Cystatin-C After 12 weeks		12 weeks
Secondary	TSQM-9 scores	Treatment Satisfaction Questionnaire for Medication-9 scores, higher scores mean a better outcome.	12 weeks