Evaluation of Efficacy and Safety of ATB-1011+ATB-1012 Co-administration for Essential Hypertension and Type II Diabetes

Study Overview
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Brief Summary
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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

Detailed Description
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Primary Objectives: To demonstrate superiority of 12-week co-administration of ATB-1011 and ATB-1012 in blood pressure control over ATB-1012 monotherapy To demonstrate superiority of 12-week co-administration of ATB-1011 and ATB-1012 in diabetes control over ATB-1011 monotherapy

Official Title
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A Randomized, Active-controlled, Double-blind, Parallel, Multi Center, Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated ATB-1011 and ATB-1012 in Patients With Essential Hypertension and Type II Diabetes Mellitus

Conditions
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Essential Hypertension, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: ATB-1011
* Drug: ATB-1012
* Drug: ATB-1013
* Drug: ATB-1011 placebo
* Drug: ATB-1012 placebo
* Drug: ATB-1013 placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those with Primary Hypertension and Type II Diabetes Mellitus (DM) Those who have been given adequate explanation about the purpose and the details of the clinical trial and have given voluntary, written informed consent Those who have not taken any antihypertensive agents for ≥2 weeks prior to randomization. Those who have not taken any oral hypoglycemic agents, except for same dose of metformin (≥1000 mg/day), for ≥8 weeks prior to randomization Exclusion Criteria: Those with reference arm mean sitting diastolic blood pressure (MSDBP) ≥110 mmHg at screening or at randomization Those with differences of systolic blood pressure (SBP) ≥ 20 mmHg and diastolic blood pressure (DBP) ≥ 10 mmHg between arms measured 3 consecutive times with ≥2 minutes between each measurement at screening Those with a history of alcohol or substance abuse Those who are pregnant or nursing Those who have received other clinical trial drugs within 12 weeks prior to screening Those who are deemed ineligible to participate in the clinical trial based on the medical opinion of the investigator

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATB-1011 + ATB-1012<br>Participants will receive 1 tablet/day of each drug for 12 weeks | Drug: ATB-1011<br>* Oral tablet<br>Drug: ATB-1012<br>* Oral tablet<br>Drug: ATB-1013 placebo<br>* Placebo matched to ATB-1013<br>|
| Experimental: ATB-1012 + ATB-1013<br>Participants will receive 1 tablet/day of each drug for 12 weeks | Drug: ATB-1012<br>* Oral tablet<br>Drug: ATB-1013<br>* Oral tablet<br>Drug: ATB-1011 placebo<br>* Placebo matched to ATB-1011<br>|
| Active Comparator: ATB-1011<br>Participants will receive 1 tablet/day of each drug for 12 weeks | Drug: ATB-1011<br>* Oral tablet<br>Drug: ATB-1012 placebo<br>* Placebo matched to ATB-1012<br>Drug: ATB-1013 placebo<br>* Placebo matched to ATB-1013<br>|
| Active Comparator: ATB-1012<br>Participants will receive 1 tablet/day of each drug for 12 weeks | Drug: ATB-1012<br>* Oral tablet<br>Drug: ATB-1011 placebo<br>* Placebo matched to ATB-1011<br>Drug: ATB-1013 placebo<br>* Placebo matched to ATB-1013<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |