| Trial ID: | L5179 |
| Source ID: | NCT04653779
|
| Associated Drug: |
Evogliptin 5mg/Metformin 1000mg
|
| Title: |
A Clinical Trial to Evaluate the Preference Regarding Convenience of Medication and Efficacy/Safety of SUGAMET®XR Tablet 5/1000mg
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Renal Disease|Diabetes Mellitus|Metabolic Disease|Endocrine System Diseases
|
| Interventions: |
DRUG: Evogliptin 5mg/Metformin 1000mg
|
| Outcome Measures: |
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|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, Urine Albumin-to-Creatinin Ratio, 12 weeks|Change from baseline in HbA1c (%) After 12 weeks NAG, N-Acetyl-Glucosaminidase, 12 weeks|Change from baseline in Nephrin After 12 weeks, 12 weeks|Change from baseline in Cystatin-C After 12 weeks, 12 weeks|TSQM-9 scores, Treatment Satisfaction Questionnaire for Medication-9 scores, higher scores mean a better outcome., 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Dong-A ST Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
54
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2020-12
|
| Completion Date: |
2021-07
|
| Results First Posted: |
|
| Last Update Posted: |
2020-12-11
|
| Locations: |
Suncheonhyang Bucheon Hospital, Bucheon, Gyeonggi, 14584, Korea, Republic of|Se-jong hospital, Bucheon, Gyeonggi, 14754, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT04653779
|
