Diabetes Mellitus, Type 2, Essential Hypertension
Conditions
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
Interventions
Sponsors
Autotelicbio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean sitting systolic blood pressure (MSSBP) (ATB-1011+ATB-1012 vs. ATB-1012) | baseline to Week 12 | Change in MSSBP with ATB-1011 + ATB-1012 co-administration compared to ATB-1012 monotherapy |
| Hemoglobin A1c (HbA1c) (ATB-1011+ATB-1012 vs. ATB-1011) | baseline to Week 12 | Changes in HbA1c with ATB-1011 + ATB-1012 co-administration compared to ATB-1011 monotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MSSBP (ATB-1011+ATB-1012 vs. ATB-1011) | baseline to Week 12 | Changes in MSSBP with ATB-1011 + ATB-1012 co-administration compared to ATB-1011 monotherapy |
| MSSBP (ATB-1012+ATB-1013 vs. ATB-1012) | baseline to Week 12 | Changes in MSSBP with ATB-1012 + ATB-1013 co-administration compared to ATB-1012 monotherapy |
| MSSBP (ATB-1012+ATB-1013 vs ATB-1011+ATB-1012) | baseline to Week 12 | Changes in MSSBP with ATB-1012 + ATB-1013 co-administration compared to ATB-1011 + ATB-1012 co-administration |
| HbA1c (ATB-1011+ATB-1012 vs. ATB-1012) | baseline to Week 12 | Changes in HbA1c with ATB-1011 + ATB-1012 co-administration compared to ATB-1012 monotherapy |
| 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 | baseline to Weeks 4, 8, and 12 | Fasting plasma glucose (FPG) |
Countries
South Korea
Contacts
STUDY_DIRECTORJames Jun, MD
Autotelicbio
Outcome results
None listed