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The purpose of this study is to evaluate safety and efficacy of ATB-1011 and ATB-1012 co-administration in patients with essential hypertension and type II diabetes mellitus
Primary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATB-1011 + ATB-1012 | Experimental | Participants will receive 1 tablet/day of each drug for 12 weeks |
|
| ATB-1012 + ATB-1013 | Experimental | Participants will receive 1 tablet/day of each drug for 12 weeks |
|
| ATB-1011 | Active Comparator | Participants will receive 1 tablet/day of each drug for 12 weeks |
|
| ATB-1012 | Active Comparator | Participants will receive 1 tablet/day of each drug for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATB-1011 | Drug | Oral tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean sitting systolic blood pressure (MSSBP) (ATB-1011+ATB-1012 vs. ATB-1012) | Change in MSSBP with ATB-1011 + ATB-1012 co-administration compared to ATB-1012 monotherapy | baseline to Week 12 |
| Hemoglobin A1c (HbA1c) (ATB-1011+ATB-1012 vs. ATB-1011) | Changes in HbA1c with ATB-1011 + ATB-1012 co-administration compared to ATB-1011 monotherapy | baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| MSSBP (ATB-1011+ATB-1012 vs. ATB-1011) | Changes in MSSBP with ATB-1011 + ATB-1012 co-administration compared to ATB-1011 monotherapy | baseline to Week 12 |
| MSSBP (ATB-1012+ATB-1013 vs. ATB-1012) |
| Measure | Description | Time Frame |
|---|---|---|
| Extension period: Changes in HbA1c | baseline and Week 12 to Weeks 18 and 24 | |
| Extension period: Changes in MSSBP | baseline and Week 12 to Weeks 18 and 24 | |
| Extension period: Changes in MSDBP |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaymin Jeong, PhD | Contact | +82-70-4242-5334 | jaymin.jeong@autotelic.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| James Jun, MD | Autotelicbio | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
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Participants will be randomized in a 1:1:1:1 ratio to 4 treatment arms. After completion of treatment period, participants will enter 12-week extension period and take 1 tab/day of ATB-1011 and ATB-1012.
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| ATB-1012 |
| Drug |
Oral tablet |
|
| ATB-1013 | Drug | Oral tablet |
|
| ATB-1011 placebo | Drug | Placebo matched to ATB-1011 |
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| ATB-1012 placebo | Drug | Placebo matched to ATB-1012 |
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| ATB-1013 placebo | Drug | Placebo matched to ATB-1013 |
|
Changes in MSSBP with ATB-1012 + ATB-1013 co-administration compared to ATB-1012 monotherapy
| baseline to Week 12 |
| MSSBP (ATB-1012+ATB-1013 vs ATB-1011+ATB-1012) | Changes in MSSBP with ATB-1012 + ATB-1013 co-administration compared to ATB-1011 + ATB-1012 co-administration | baseline to Week 12 |
| HbA1c (ATB-1011+ATB-1012 vs. ATB-1012) | Changes in HbA1c with ATB-1011 + ATB-1012 co-administration compared to ATB-1012 monotherapy | baseline to Week 12 |
| Changes in MSSBP | baseline to Weeks 4 and 8 |
| Changes in mean sitting diastolic blood pressure (MSDBP) | baseline to Weeks 4, 8, and 12 |
| Changes in HbA1c | baseline to Weeks 4, 8, and 12 |
| Changes in glycemic parameters | Fasting plasma glucose (FPG) | baseline to Weeks 4, 8, and 12 |
| Changes in glycemic parameters | Homeostatic model assessment of beta cell function (HOMA-beta) | baseline to Weeks 4, 8, and 12 |
| Changes in glycemic parameters | Homeostatic model assessment of insulin resistance (HOMA-IR) | baseline to Weeks 4, 8, and 12 |
| baseline and Week 12 to Weeks 18 and 24 |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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