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

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

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

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Essential Hypertension
• Intervention / Treatment: Drug: ATB-1011; Drug: ATB-1012; Drug: ATB-1013 placebo; Drug: ATB-1013; Drug: ATB-1011 placebo; Drug: ATB-1012 placebo

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

• Study Type: Interventional
• Enrollment (Anticipated): 248
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jaymin Jeong, PhD; Phone Number: +82-70-4242-5334; Email: jaymin.jeong@autotelic.co.kr

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Dong-Ju Choi, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	baseline and Week 12 to Weeks 18 and 24

Collaborators and Investigators

• Sponsor: Autotelicbio
• Investigators: Study Director: James Jun, MD, Autotelicbio

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2; Essential Hypertension
• Other Study ID Numbers: ATB-101-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No