Actively Recruiting
A Randomized, Double-blind, Multi-center Trial to Evaluate the Efficacy and Safety of Combination Therapy with THP-00101, THP-00102, and THP-00103 in Adults with Type 2 Diabetes and Essential Hypertension
Led by THPharm Corp. · Updated on 2025-09-12
221
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of combination therapy using THP-00101 (Dapagliflozin 10 mg) and THP-00102 (Telmisartan 80 mg) compared to each drug alone in adults with type 2 diabetes mellitus accompanied by essential hypertension. This phase 3, randomized, double-blind, multi-center trial aims to show the superiority of the combination therapy in improving blood sugar control measured by hemoglobin A1c (HbA1c) and lowering mean sitting systolic blood pressure (MSSBP) over 12 weeks. Additional evaluations include secondary efficacy and safety of different drug combinations including THP-00103 (Telmisartan 40 mg).
CONDITIONS
Brief 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, or between 130 and 160 mmHg if taking antihypertensive agents at screening and baseline
- Using metformin monotherapy or dual therapy including metformin for at least 8 weeks from screening or no oral hypoglycemic agents within 8 weeks
- Able to discontinue other oral hypoglycemic and antihypertensive agents except metformin during the study
- Provided written informed consent
- Compliance of 70% or higher with the investigational product during the run-in period
You will not qualify if you...
- Mean sitting diastolic blood pressure (MSDBP) greater than or equal to 110 mmHg at screening and randomization
- Large differences in mean blood pressure between arms at screening (MSSBP ≥20 mmHg and MSDBP ≥10 mmHg)
- Body mass index (BMI) over 35 kg/m2
- Liver problems such as severe hepatic impairment or high liver enzyme levels
- Moderate to severe kidney impairment (eGFR <45 mL/min/1.73 m2) or acute kidney affecting conditions
- Acute or severe infections, diabetic coma, malnutrition, or other serious systemic conditions
- Orthostatic hypotension with symptoms
- Serious heart rhythm disorders or severe heart diseases
- Autoimmune, connective tissue diseases, or wasting diseases
- Urinary or genital infections within 16 weeks before screening
- Recent malignant tumors within 5 years (exceptions based on medical judgment)
- Recent cardiovascular or cerebrovascular events within 24 weeks before screening
- Use of certain medications or surgeries affecting weight or blood pressure within specific timeframes
- Hypersensitivity to study drugs or metformin
- Participation in other clinical trials within 12 weeks
- Pregnant or breastfeeding women or those planning pregnancy without effective contraception
- Investigator judgment deeming unsuitability for participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive combination therapy with investigational drugs or placebos once a day by mouth.
Visits at baseline, Week 4, Week 8, and Week 12
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.
J
Jaewoo Park
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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