Actively Recruiting
A Randomized, Double-blind, Multi-center, Active-controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of THP-00101, THP-00102, and THP-00103 in Subjects With T2DM and Essential Hypertension
Led by THPharm Corp. · Updated on 2025-09-12
221
Participants Needed
2
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
\[Primary Objective\] To demonstrate the superiority of the change in mean sitting systolic blood pressure (MSSBP) and hemoglobin A1c (HbA1c)on week 12 of the combination therapy of THP-00101 (dapagliflozin 10 mg) and THP-00102 (telmisartan 80 mg) compared to THP-00101 or THP-00102 monotherapy among subjects with type 2 diabetes mellitus accompanied by essential hypertension. \[Secondary Objective\] To comparatively evaluate secondary efficacy and safety in the THP-00101 monotherapy group, THP-00102 monotherapy group, THP-00101 and THP-00102 combination therapy group, and THP-00101 and THP-00103 (telmisartan 40 mg) combination therapy group among subjects with type 2 diabetes mellitus accompanied by essential hypertension.
CONDITIONS
Official Title
A Randomized, Double-blind, Multi-center, Active-controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of THP-00101, THP-00102, and THP-00103 in Subjects With T2DM and Essential Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years and older
- Diagnosed with type 2 diabetes mellitus accompanied by essential hypertension
- Hemoglobin A1c between 6.5% and 9.5% at screening and baseline
- Fasting plasma glucose less than or equal to 270 mg/dL at screening and baseline
- Mean sitting systolic blood pressure (MSSBP) between 140 and 160 mmHg if not taking antihypertensive agents
- MSSBP between 130 and 160 mmHg if taking antihypertensive agents
- Willingness to discontinue oral hypoglycemic and antihypertensive agents other than metformin during the study, maintaining metformin at a minimum of 1,000 mg/day
- Compliance of 70% or higher with investigational product during run-in period
- Provided written informed consent after explanation of study objectives and procedures
You will not qualify if you...
- Mean sitting diastolic blood pressure (MSDBP) 110 mmHg or higher at screening or randomization
- Difference in mean blood pressure between arms of 20 mmHg or higher systolic and 10 mmHg or higher diastolic at screening
- Body mass index (BMI) greater than 35 kg/m2
- Liver impairment including mild to severe hepatic impairment or elevated liver enzymes (AST or ALT ≥2 times upper limit)
- Biliary obstruction or cholestasis
- Moderate or severe renal impairment (eGFR <45 mL/min/1.73 m2)
- Acute conditions affecting renal function such as dehydration, severe infection, shock, or sepsis
- Diabetic precoma or coma
- Severe infection or trauma
- Malnutrition or metabolic disorders including adrenal or pituitary dysfunction
- Respiratory failure or gastrointestinal disorders affecting drug absorption
- Symptomatic orthostatic hypotension
- Significant arrhythmias or severe heart valve diseases
- Autoimmune, connective tissue, or wasting diseases
- Uncontrolled urinary disorders
- Positive for hepatitis B surface antigen or hepatitis C antibody unless stably treated
- Positive HIV antigen/antibody test
- History of hereditary angioedema or angioedema related to ACE inhibitors or angiotensin II antagonists
- Type 1 diabetes or secondary diabetes
- Drug or alcohol abuse
- Secondary hypertension or suspected secondary hypertension conditions
- Severe heart failure or ischemic heart disease within 24 weeks
- Severe cerebrovascular disease within 24 weeks
- Recent moderate or malignant retinopathy
- Recent urinary or genital infection
- Malignant tumors within 5 years except certain cured cancers based on investigator judgment
- Recent bariatric or coronary artery surgery
- Use of significant weight control drugs within 12 weeks
- Use of systemic corticosteroids for 2 weeks or longer within 8 weeks
- Insulin or GLP-1 receptor agonists use within 8 weeks
- Current triple antihypertensive therapy or dual with high-dose amlodipine
- Use of hypoglycemic agents other than metformin or triple combination including metformin
- Use of drugs containing aliskiren
- Current dialysis treatment
- Planned intravenous radiographic contrast tests during study
- Hypersensitivity to study drugs or metformin
- Participation in other clinical trials within 12 weeks
- Pregnant or breastfeeding women
- Women and men not agreeing to effective contraception measures during study
- Any condition judged by investigator as unsuitable for participation
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The Catholic University of Korea, Yeouido ST. Mary's Hospital
Seoul, South Korea, 07345
Actively Recruiting
2
Thammasat University Hospital
Pathum Thani, Changwat Pathum Thani, Thailand, 12120
Not Yet Recruiting
Research Team
T
Taehee Han, Dr.
CONTACT
J
Jaewoo Park
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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