A Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Double-blind, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy in Patients With Essential Hypertension and Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06220773
• Other study ID #: BR-FDC-CT-301
• Status: Recruiting
• Phase: Phase 3
• Start date: May 21, 2024
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: Shin-young Oh
• Phone: +82-2-708-8000
• Email: syoh[@]boryung.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this clinical study is to Evaluate the Efficacy and Safety of BR1019A and BR1019B combination therapy in Patients with Essential Hypertension and Type 2 Diabetes Mellitus

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 276
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Those with type 2 diabetes mellitus & essential hypertension

• Those who agree to discontinue existing antihypertensive and/or oral hypoglycemic drugs during the clinical trial

• Those who are judged medically reasonable by investigator to be able to discontinue existing antihypertensive and/or oral hypoglycemic drugs(except for Metformin) during the clinical trial

Exclusion Criteria:

• Those who meet the following criteria

• Those with a history of secondary hypertension or suspected secondary hypertension; (Including but not limited to; e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, primary hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.)

• Those with clinical significant orthostatic hypotension accompanied by symptoms

• Those with diabetes mellitus taking renin inhibitors(Aliskiren) or moderate to severe renal impairment

• Those with diabetic nephropathy taking ACE inhibitors

• Those with type 1 diabetes mellitus, secondary diabetes mellitus, severe insulin-dependent diabetes, diabetic ketoacidosis or lactic acidosis

• Those with uncontrolled, severe diabetic complications (Micro-vascular complications(e.g., nephropathy, retinopathy, neuropathy, etc.), Macro-vascular complications)

• Diabetic coma or pre-coma

Related Conditions & MeSH terms

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

Intervention

Drug:
• BR1019A
Subjects take the investigational products once a day for 12 weeks.
• BR1019B
Subjects take the investigational products once a day for 12 weeks.
• BR1019C
Subjects take the investigational products once a day for 12 weeks.
• BR1019A-1
Subjects take the investigational products once a day for 12 weeks.
• BR1019B-1
Subjects take the investigational products once a day for 12 weeks.
• BR1019C-1
Subjects take the investigational products once a day for 12 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of mean sitting systolic blood pressure from baseline in BR1019A+BR1019B+BR1019C-1 at Week 12 compared to BR1019A-1+BR1019B+BR1019C-1		12 weeks from Baseline Visit
Primary	The change of HbA1c from baseline in BR1019A+BR1019B+BR1019C-1 at Week 12 compared to BR1019A+BR1019B-1+BR1019C-1		12 weeks from Baseline Visit