Clinical trial NCT05573477: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Essential Hypertension
Diabetes Mellitus, Type 2
Lead sponsor: Autotelicbio
Sponsor class: INDUSTRY
First posted: 2022-10-10
Enrollment: 248
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Mean sitting systolic blood pressure (MSSBP) (ATB-1011+ATB-1012 vs. ATB-1012)
timeFrame: baseline to Week 12
measure: Hemoglobin A1c (HbA1c) (ATB-1011+ATB-1012 vs. ATB-1011)
timeFrame: baseline to Week 12
Secondary outcomes:
measure: MSSBP (ATB-1011+ATB-1012 vs. ATB-1011)
timeFrame: baseline to Week 12
measure: MSSBP (ATB-1012+ATB-1013 vs. ATB-1012)
timeFrame: baseline to Week 12
measure: MSSBP (ATB-1012+ATB-1013 vs ATB-1011+ATB-1012)
timeFrame: baseline to Week 12
measure: HbA1c (ATB-1011+ATB-1012 vs. ATB-1012)
timeFrame: baseline to Week 12
measure: Changes in MSSBP
timeFrame: baseline to Weeks 4 and 8
measure: Changes in mean sitting diastolic blood pressure (MSDBP)
timeFrame: baseline to Weeks 4, 8, and 12
measure: Changes in HbA1c
timeFrame: baseline to Weeks 4, 8, and 12
measure: Changes in glycemic parameters
timeFrame: baseline to Weeks 4, 8, and 12
measure: Changes in glycemic parameters
timeFrame: baseline to Weeks 4, 8, and 12
measure: Changes in glycemic parameters
timeFrame: baseline to Weeks 4, 8, and 12
Other outcomes:
measure: Extension period: Changes in HbA1c
timeFrame: baseline and Week 12 to Weeks 18 and 24
measure: Extension period: Changes in MSSBP
timeFrame: baseline and Week 12 to Weeks 18 and 24
measure: Extension period: Changes in MSDBP
timeFrame: baseline and Week 12 to Weeks 18 and 24
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Autotelicbio
name: James Jun, MD
role: STUDY_DIRECTOR
References: