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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
248
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGMean 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
Time frame: 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
Time frame: baseline to Week 12
MSSBP (ATB-1011+ATB-1012 vs. ATB-1011)
Changes in MSSBP with ATB-1011 + ATB-1012 co-administration compared to ATB-1011 monotherapy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline to Week 12
Changes in MSSBP
Time frame: baseline to Weeks 4 and 8
Changes in mean sitting diastolic blood pressure (MSDBP)
Time frame: baseline to Weeks 4, 8, and 12
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Placebo matched to ATB-1011
Placebo matched to ATB-1012
Placebo matched to ATB-1013
Changes in HbA1c
Time frame: baseline to Weeks 4, 8, and 12
Changes in glycemic parameters
Fasting plasma glucose (FPG)
Time frame: baseline to Weeks 4, 8, and 12
Changes in glycemic parameters
Homeostatic model assessment of beta cell function (HOMA-beta)
Time frame: baseline to Weeks 4, 8, and 12
Changes in glycemic parameters
Homeostatic model assessment of insulin resistance (HOMA-IR)
Time frame: baseline to Weeks 4, 8, and 12