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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05573477
• Other study ID #: ATB-101-003
• Status: Recruiting
• Phase: Phase 3
• Start date: November 16, 2022
• Est. completion date: June 2024

Study information

• Verified date: January 2023
• Source: Autotelicbio
• Contact: Jaymin Jeong, PhD
• Phone: +82-70-4242-5334
• Email: jaymin.jeong[@]autotelic.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: June 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Essential Hypertension
• Hypertension

Intervention

Drug:
• ATB-1011
Oral tablet
• ATB-1012
Oral tablet
• ATB-1013
Oral tablet
• ATB-1011 placebo
Placebo matched to ATB-1011
• ATB-1012 placebo
Placebo matched to ATB-1012
• ATB-1013 placebo
Placebo matched to ATB-1013

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Autotelicbio

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Extension period: Changes in HbA1c		baseline and Week 12 to Weeks 18 and 24
Other	Extension period: Changes in MSSBP		baseline and Week 12 to Weeks 18 and 24
Other	Extension period: Changes in MSDBP		baseline and Week 12 to Weeks 18 and 24
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in MSSBP		baseline to Weeks 4 and 8
Secondary	Changes in mean sitting diastolic blood pressure (MSDBP)		baseline to Weeks 4, 8, and 12
Secondary	Changes in HbA1c		baseline to Weeks 4, 8, and 12
Secondary	Changes in glycemic parameters	Fasting plasma glucose (FPG)	baseline to Weeks 4, 8, and 12
Secondary	Changes in glycemic parameters	Homeostatic model assessment of beta cell function (HOMA-beta)	baseline to Weeks 4, 8, and 12
Secondary	Changes in glycemic parameters	Homeostatic model assessment of insulin resistance (HOMA-IR)	baseline to Weeks 4, 8, and 12