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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Patients receive Evogliptin 5mg/Metformin 1000mg once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evogliptin 5mg/Metformin 1000mg | Drug | Size reduction of a tablet formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sung | Contact | 82-2-920-8369 | jhsung@donga.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suncheonhyang Bucheon Hospital | Bucheon-si | Gyeonggi-do | 14584 | South Korea |
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| 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 |
| Se-jong hospital | Bucheon-si | Gyeonggi-do | 14754 | South Korea |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007674 | Kidney Diseases |
| D003920 | Diabetes Mellitus |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C557982 | 4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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