RecruitingPhase 3NCT06647745

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


Sponsor

THPharm Corp.

Enrollment

221 participants

Start Date

Apr 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

\[Primary Objective\] 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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination pill that addresses both type 2 diabetes and high blood pressure at the same time. Researchers want to know if taking three medications together (dapagliflozin, telmisartan, and metformin) works better than existing two-drug combos. **You may be eligible if...** - You are 19 or older - You have type 2 diabetes AND high blood pressure - Your HbA1c (average blood sugar) is between 6.5% and 9.5% - Your blood sugar (fasting) is 270 mg/dL or below - Your systolic blood pressure is between 140 and 160 mmHg - You are currently on metformin alone or not on diabetes medication **You may NOT be eligible if...** - Your BMI is over 35 - You have moderate to severe kidney problems - You have serious heart conditions (heart failure class III/IV, recent heart attack, or unstable angina within the past 6 months) - You had a stroke within the past 6 months - You are pregnant or breastfeeding - You have liver disease or elevated liver enzymes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTHP-00101

Dapagliflozin 10 mg

DRUGTHP-00102

Telmisartan 80 mg

DRUGTHP-00103

Telmisartan 40 mg

DRUGTHP-00104

Placebo of Dapagliflozin 10mg

DRUGTHP-00105

Placebo of Telmisartan 80mg

DRUGTHP-00106

Placebo of Telmisartan 40mg


Locations(2)

The Catholic University of Korea, Yeouido ST. Mary's Hospital

Seoul, South Korea

Thammasat University Hospital

Pathum Thani, Changwat Pathum Thani, Thailand

View Full Details on ClinicalTrials.gov

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NCT06647745


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