Diabetes Mellitus, Diabetes Mellitus, Type 2, Endocrine System Diseases, Metabolic Disease, Renal Disease
Conditions
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
Interventions
DRUGEvogliptin 5mg/Metformin 1000mg
Size reduction of a tablet formulation
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 12 weeks | Treatment Satisfaction Questionnaire for Medication-9 scores, higher scores mean a better outcome. |
| Change from baseline in HbA1c (%) After 12 weeks NAG | 12 weeks | N-Acetyl-Glucosaminidase |
Countries
South Korea
Contacts
Primary ContactSung
Outcome results
None listed