Back to resultsEvaluation of Efficacy and Safety of ATB-1011+ATB-1012 Co-administration for Essential Hypertension and Type II Diabetes
Primary Purpose
Essential Hypertension, Diabetes Mellitus, Type 2
Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ATB-1011
ATB-1012
ATB-1013
ATB-1011 placebo
ATB-1012 placebo
ATB-1013 placebo
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension
Eligibility Criteria
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
Sites / Locations
- Seoul National University Bundang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
ATB-1011 + ATB-1012
ATB-1012 + ATB-1013
ATB-1011
ATB-1012
Arm Description
Participants will receive 1 tablet/day of each drug for 12 weeks
Participants will receive 1 tablet/day of each drug for 12 weeks
Participants will receive 1 tablet/day of each drug for 12 weeks
Participants will receive 1 tablet/day of each drug for 12 weeks
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
MSSBP (ATB-1011+ATB-1012 vs. ATB-1011)
Changes in MSSBP with ATB-1011 + ATB-1012 co-administration compared to ATB-1011 monotherapy
MSSBP (ATB-1012+ATB-1013 vs. ATB-1012)
Changes in MSSBP with ATB-1012 + ATB-1013 co-administration compared to ATB-1012 monotherapy
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
HbA1c (ATB-1011+ATB-1012 vs. ATB-1012)
Changes in HbA1c with ATB-1011 + ATB-1012 co-administration compared to ATB-1012 monotherapy
Changes in MSSBP
Changes in mean sitting diastolic blood pressure (MSDBP)
Changes in HbA1c
Changes in glycemic parameters
Fasting plasma glucose (FPG)
Changes in glycemic parameters
Homeostatic model assessment of beta cell function (HOMA-beta)
Changes in glycemic parameters
Homeostatic model assessment of insulin resistance (HOMA-IR)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05573477
Brief Title
Evaluation of Efficacy and Safety of ATB-1011+ATB-1012 Co-administration for Essential Hypertension and Type II Diabetes
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Autotelicbio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
248 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ATB-1011 + ATB-1012
Arm Type
Experimental
Arm Description
Participants will receive 1 tablet/day of each drug for 12 weeks
Arm Title
ATB-1012 + ATB-1013
Arm Type
Experimental
Arm Description
Participants will receive 1 tablet/day of each drug for 12 weeks
Arm Title
ATB-1011
Arm Type
Active Comparator
Arm Description
Participants will receive 1 tablet/day of each drug for 12 weeks
Arm Title
ATB-1012
Arm Type
Active Comparator
Arm Description
Participants will receive 1 tablet/day of each drug for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ATB-1011
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
ATB-1012
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
ATB-1013
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
ATB-1011 placebo
Intervention Description
Placebo matched to ATB-1011
Intervention Type
Drug
Intervention Name(s)
ATB-1012 placebo
Intervention Description
Placebo matched to ATB-1012
Intervention Type
Drug
Intervention Name(s)
ATB-1013 placebo
Intervention Description
Placebo matched to ATB-1013
Primary Outcome Measure Information:
Title
Mean sitting systolic blood pressure (MSSBP) (ATB-1011+ATB-1012 vs. ATB-1012)
Description
Change in MSSBP with ATB-1011 + ATB-1012 co-administration compared to ATB-1012 monotherapy
Time Frame
baseline to Week 12
Title
Hemoglobin A1c (HbA1c) (ATB-1011+ATB-1012 vs. ATB-1011)
Description
Changes in HbA1c with ATB-1011 + ATB-1012 co-administration compared to ATB-1011 monotherapy
Time Frame
baseline to Week 12
Secondary Outcome Measure Information:
Title
MSSBP (ATB-1011+ATB-1012 vs. ATB-1011)
Description
Changes in MSSBP with ATB-1011 + ATB-1012 co-administration compared to ATB-1011 monotherapy
Time Frame
baseline to Week 12
Title
MSSBP (ATB-1012+ATB-1013 vs. ATB-1012)
Description
Changes in MSSBP with ATB-1012 + ATB-1013 co-administration compared to ATB-1012 monotherapy
Time Frame
baseline to Week 12
Title
MSSBP (ATB-1012+ATB-1013 vs ATB-1011+ATB-1012)
Description
Changes in MSSBP with ATB-1012 + ATB-1013 co-administration compared to ATB-1011 + ATB-1012 co-administration
Time Frame
baseline to Week 12
Title
HbA1c (ATB-1011+ATB-1012 vs. ATB-1012)
Description
Changes in HbA1c with ATB-1011 + ATB-1012 co-administration compared to ATB-1012 monotherapy
Time Frame
baseline to Week 12
Title
Changes in MSSBP
Time Frame
baseline to Weeks 4 and 8
Title
Changes in mean sitting diastolic blood pressure (MSDBP)
Time Frame
baseline to Weeks 4, 8, and 12
Title
Changes in HbA1c
Time Frame
baseline to Weeks 4, 8, and 12
Title
Changes in glycemic parameters
Description
Fasting plasma glucose (FPG)
Time Frame
baseline to Weeks 4, 8, and 12
Title
Changes in glycemic parameters
Description
Homeostatic model assessment of beta cell function (HOMA-beta)
Time Frame
baseline to Weeks 4, 8, and 12
Title
Changes in glycemic parameters
Description
Homeostatic model assessment of insulin resistance (HOMA-IR)
Time Frame
baseline to Weeks 4, 8, and 12
Other Pre-specified Outcome Measures:
Title
Extension period: Changes in HbA1c
Time Frame
baseline and Week 12 to Weeks 18 and 24
Title
Extension period: Changes in MSSBP
Time Frame
baseline and Week 12 to Weeks 18 and 24
Title
Extension period: Changes in MSDBP
Time Frame
baseline and Week 12 to Weeks 18 and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaymin Jeong, PhD
Phone
+82-70-4242-5334
Email
jaymin.jeong@autotelic.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Jun, MD
Organizational Affiliation
Autotelicbio
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Ju Choi, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Efficacy and Safety of ATB-1011+ATB-1012 Co-administration for Essential Hypertension and Type II Diabetes
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