Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6818
Source ID: NCT06647745
Associated Drug: Thp-00101
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
Acronym: THP-001-031
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Hypertension
Interventions: DRUG: THP-00101|DRUG: THP-00102|DRUG: THP-00103|DRUG: THP-00104|DRUG: THP-00105|DRUG: THP-00106
Outcome Measures: Primary: Changes in Hemoglobin A1c (HbA1c), The Hemoglobin A1c will be measured using the high-performance liquid chromatography (HPLC) method., 12 weeks|Changes in Mean Sitting Systolic Blood Pressure (MSSBP), When using a digital blood pressure monitor, the subject should sit on a chair with their back supported, relax for at least 5 minutes, and keep their arm at heart level during the measurement, 12 Weeks | Secondary: Changes in glycemic parameter: hemoglobin A1c, HbA1c will be measured, 4, 8, and 12 weeks from baseline|Changes in glycemic parameter: fasting plasma glucose, FPG will be measured, 4, 8, and 12 weeks from baseline|Changes in glycemic parameter: homeostasis model assessment of insulin resistance (HOMA-IR), HOMA-IR will be measured using high-performance liquid chromatography and the hexokinase method., 4, 8, and 12 weeks from baseline|Changes in glycemic parameter: homeostasis model assessment of beta-cell function (HOMA-beta), HOMA-beta will be measured using high-performance liquid chromatography and the hexokinase method, 4, 8, and 12 weeks from baseline|Changes in blood pressure: mean sitting systolic blood pressure, When using a digital blood pressure monitor, the subject should sit on a chair with their back supported, relax for at least 5 minutes, and keep their arm at heart level during the measurement, 4, 8, and 12 weeks from baseline|Changes in blood pressure: mean sitting diastolic blood pressure, When using a digital blood pressure monitor, the subject should sit on a chair with their back supported, relax for at least 5 minutes, and keep their arm at heart level during the measurement, 4, 8, and 12 weeks from baseline|Changes in blood pressure: pulse pressure, When using a digital blood pressure monitor, the subject should sit on a chair with their back supported, relax for at least 5 minutes, and keep their arm at heart level during the measurement, 4, 8, and 12 weeks from baseline|Changes in blood pressure: percentage of normalized blood pressure, When using a digital blood pressure monitor, the subject should sit on a chair with their back supported, relax for at least 5 minutes, and keep their arm at heart level during the measurement, 4, 8, and 12 weeks from baseline|Changes in blood pressure: response rate of blood pressure, When using a digital blood pressure monitor, the subject should sit on a chair with their back supported, relax for at least 5 minutes, and keep their arm at heart level during the measurement, 4, 8, and 12 weeks from baseline
Sponsor/Collaborators: Sponsor: THPharm Corp.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 221
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-04-10
Completion Date: 2026-12-01
Results First Posted:
Last Update Posted: 2025-04-15
Locations: The Catholic University of Korea, Yeouido ST. Mary's Hospital, Seoul, 07345, Korea, Republic of|Thammasat University Hospital, Pathumthani, 12120, Thailand
URL: https://clinicaltrials.gov/show/NCT06647745