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

Autotelic Bio

Status and phase: Enrolling; Phase 3

Conditions: Essential Hypertension; Diabetes Mellitus, Type 2

Treatments: Drug: ATB-1013 placebo; Drug: ATB-1012; Drug: ATB-1011; Drug: ATB-1013; Drug: ATB-1012 placebo; Drug: ATB-1011 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05573477

ATB-101-003

Details and patient eligibility

About

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

Full 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

Enrollment: 248 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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248 participants in 4 patient groups

ATB-1011 + ATB-1012

Experimental group

Description:

Participants will receive 1 tablet/day of each drug for 12 weeks

Treatment:

Drug: ATB-1012

Drug: ATB-1013 placebo

Drug: ATB-1011

ATB-1012 + ATB-1013

Experimental group

Description:

Participants will receive 1 tablet/day of each drug for 12 weeks

Treatment:

Drug: ATB-1012

Drug: ATB-1011 placebo

Drug: ATB-1013

ATB-1011

Active Comparator group

Description:

Participants will receive 1 tablet/day of each drug for 12 weeks

Treatment:

Drug: ATB-1012 placebo

Drug: ATB-1013 placebo

Drug: ATB-1011

ATB-1012

Active Comparator group

Description:

Participants will receive 1 tablet/day of each drug for 12 weeks

Treatment:

Drug: ATB-1012

Drug: ATB-1011 placebo

Drug: ATB-1013 placebo