NCT06647745

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 221 (estimated)
• Sponsor: THPharm Corp. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes
• Hypertension

Interventions

Type	Name	Description
DRUG	THP-00101	Dapagliflozin 10 mg
DRUG	THP-00102	Telmisartan 80 mg
DRUG	THP-00103	Telmisartan 40 mg
DRUG	THP-00104	Placebo of Dapagliflozin 10mg
DRUG	THP-00105	Placebo of Telmisartan 80mg
DRUG	THP-00106	Placebo of Telmisartan 40mg

Timeline

• Start date: 2025-04-10
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-10-18
• Last updated: 2025-09-12

Locations

2 sites across 2 countries: South Korea, Thailand