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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes, Hypertension

In brief

\[Primary Objective\] 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.

Key facts

Study ID

NCT06647745

Run by

THPharm Corp.

People needed

221

Starts

2025-04-10

Expected to finish

2026-12-01

Last updated by the study team

2025-09-12

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Screening (V1)
• Adult males and females aged 19 (the legal adult age of each country) and above on the date of written informed consent
• Subjects with type 2 diabetes mellitus accompanied by essential hypertension
• Subjects with the following hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) levels at screening (V1)*
• hemoglobin A1c less than or equal to 9.5% and more than 6.5%
• fasting plasma glucose less than or equal to 270 mg/dL
• Including subjects who did not use oral hypoglycemic agents within 8 weeks from screening and subjects who took metformin monotherapy or dual combination therapy that included metformin for 8 weeks or longer from screening 4. Subjects with the following mean sitting systolic blood pressure (MSSBP) measured in the reference arm** at screening (V1)***
• If not taking antihypertensive agents: MSSBP less than 160 mmHg and more than 140 mmHg
• If taking antihypertensive agents: MSSBP less than 160 mmHg and more than 130 mmHg **Reference arm: The arm with the higher MSSBP after measuring it 3 times in each arm at screening (V1) (If the MSSBP is the same between both arms, then the arm with the higher mean sitting diastolic blood pressure (MSDBP) is selected as the reference arm.)
• **Classified based on whether antihypertensive agents were administered within 4 weeks from screening (V1) 5 Subjects considered by the investigator appropriate to discontinue the use of oral hypoglycemic agents and antihypertensive agents, other than the existing metformin, during the study (with metformin maintained at a minimum of 1,000 mg/day) 6 Subjects who received a sufficient explanation of the objectives and content of the study and voluntarily provided written informed consent
• Baseline (V2)
• Subjects with the following HbA1c and FPG levels at baseline (V2) - HbA1c less than or equal to 9.5% and more than 6.5% - FPG less than or equal to 270 mg/dL 2. Subjects with the following MSSBP measured in the reference arm at baseline (V2) - MSSBP less than 160 mmHg and more than 140 mmHg 3. Subjects who did not take oral hypoglycemic agents other than the same dose of metformin (More than 1,000 mg/day) for at least 8 weeks before baseline (V2) 4. Subjects who did not take antihypertensive agents for at least 2 weeks before baseline (V2) 5. Subjects with no disqualifying inclusion/exclusion criteria of screening (V1) when evaluating eligibility again at baseline (V2) 6. Subjects with compliance of 70% or higher with the investigational product during the run-in period
• Extension Period
• Subjects who have completed all procedures of the treatment period. Subjects who are unsuitable to participate in the study of the extension period, considering safety, etc., can be excluded.
• Subjects who received a sufficient explanation of the objectives and content of the extension period study and voluntarily provided written informed consent

You may not qualify if…

• Subjects with the following blood pressures measured at screening (V1) and randomization (V2)
• (1) Subjects with the following MSDBP measured in the reference arm
• MSDBP ≥110 mmHg (2) Subjects with the following difference in mean blood pressure measured three times consecutively in each arm at least 2 minutes apart at screening (V1): MSSBP ≥20 mmHg and MSDBP ≥10 mmHg 2. Subjects with a BMI of >35 kg/m2 3. Subjects with the following comorbidities or conditions
• Mild to severe hepatic impairment
• Biliary obstruction or cholestasis
• AST or ALT ≥2 x ULN
• Total bilirubin >2 x ULN
• Patients with moderate (stage 3b) or severe renal impairment (eGFR by IDMS-MDRD <45 mL/min/1.73 m2)
• Acute conditions that may affect renal function, such as dehydration, severe infection, cardiovascular collapse (shock), and sepsis
• Diabetic precoma and coma
• Severe infection or severe traumatism
• Malnutrition, starvation, debilitation, pituitary insufficiency, or adrenal dysfunction
• Acute or chronic diseases that may cause tissue hypoxia such as respiratory failure (pulmonary infarction and severe pulmonary dysfunction) and shock, and gastrointestinal disorders including dehydration, diarrhea, and vomiting
• Orthostatic hypotension with symptoms
• Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmia considered clinically significant as judged by the investigator
• Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve stenosis
• Wasting diseases, autoimmune diseases, and connective tissue diseases
• Dysuria, anuria, oliguria, and ischuria that cannot be controlled by drugs
• Gastrointestinal diseases that may affect the absorption of the investigational product (gastrointestinal ulcer, gastritis, gastric spasm, gastroesophageal reflux disease, Crohn's disease, etc.)
• Subjects who are HBsAg positive§ or HCV antibody positive∥
• §Subjects who are taking antiviral products stably may participate
• ∥Subjects with negative HCV RNA test results may participate
• Subjects who are positive for HIV Ag/Ab combo test 4. Subjects with the following past medical history
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• Hereditary angioedema or angioedema caused by ACE inhibitor or angiotensin II antagonist treatment.

Where it is running

• The Catholic University of Korea, Yeouido ST. Mary's Hospital — Seoul, South Korea (enrolling)
• Thammasat University Hospital — Pathum Thani, Changwat Pathum Thani, Thailand

Full record on ClinicalTrials.gov

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