A Randomized, Double-blind, Multi-center, Active-controlled, Phase 3 Clinical Trial to Eva
\[Primary Objective\] 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
| Condition(s) | Type 2 Diabetes, Hypertension |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * Screening (V1) 1. Adult males and females aged 19 (the legal adult age of each country) and above on the date of written informed consent 2. Subjects with type 2 diabetes mellitus accompanied by essential hypertension 3. 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 |
| Ages | 19 Years |
| Sex | All |
| Lead sponsor | THPharm Corp. |
| Locations | Seoul, South Korea; Pathum Thani, Changwat Pathum Thani, Thailand |
| Start date | 2025-04-10 |
| NCT ID | NCT06647745 |
| Official listing | https://clinicaltrials.gov/study/NCT06647745 |