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
THPharm Corp.
221 participants
Apr 10, 2025
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
Plain Language Summary
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Interventions
Dapagliflozin 10 mg
Telmisartan 80 mg
Telmisartan 40 mg
Placebo of Dapagliflozin 10mg
Placebo of Telmisartan 80mg
Placebo of Telmisartan 40mg
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06647745