Hypertension, Type 2 Diabetes
Conditions
Brief 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.
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
Sponsors
THPharm Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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 arm\*\* at screening (V1)\*\*\* * If not taking antihypertensive agents: MSSBP less than 160 mmHg and more than 140 mmHg * If taking antihypertensive agents: MSSBP less than 160 mmHg and more than 130 mmHg \*\*Reference arm: The arm with the higher MSSBP after measuring it 3 times in each arm at screening (V1) (If the MSSBP is the same between both arms, then the arm with the higher mean sitting diastolic blood pressure (MSDBP) is selected as the reference arm.) \*\*\*Classified based on whether antihypertensive agents were administered within 4 weeks from screening (V1) 5 Subjects considered by the investigator appropriate to discontinue the use of oral hypoglycemic agents and antihypertensive agents, other than the existing metformin, during the study (with metformin maintained at a minimum of 1,000 mg/day) 6 Subjects who received a sufficient explanation of the objectives and content of the study and voluntarily provided written informed consent * Baseline (V2) 1\. Subjects with the following HbA1c and FPG levels at baseline (V2) - HbA1c less than or equal to 9.5% and more than 6.5% - FPG less than or equal to 270 mg/dL 2. Subjects with the following MSSBP measured in the reference arm at baseline (V2) - MSSBP less than 160 mmHg and more than 140 mmHg 3. Subjects who did not take oral hypoglycemic agents other than the same dose of metformin (More than 1,000 mg/day) for at least 8 weeks before baseline (V2) 4. Subjects who did not take antihypertensive agents for at least 2 weeks before baseline (V2) 5. Subjects with no disqualifying inclusion/
Exclusion criteria
of screening (V1) when evaluating eligibility again at baseline (V2) 6. Subjects with compliance of 70% or higher with the investigational product during the run-in period * Extension Period 1. Subjects who have completed all procedures of the treatment period. Subjects who are unsuitable to participate in the study of the extension period, considering safety, etc., can be excluded. 2. Subjects who received a sufficient explanation of the objectives and content of the extension period study and voluntarily provided written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Hemoglobin A1c (HbA1c) | 12 weeks | The Hemoglobin A1c will be measured using the high-performance liquid chromatography (HPLC) method. |
| Changes in Mean Sitting Systolic Blood Pressure (MSSBP) | 12 Weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in glycemic parameter: fasting plasma glucose | 4, 8, and 12 weeks from baseline | FPG will be measured |
| Changes in glycemic parameter: homeostasis model assessment of insulin resistance (HOMA-IR) | 4, 8, and 12 weeks from baseline | HOMA-IR will be measured using high-performance liquid chromatography and the hexokinase method. |
| Changes in glycemic parameter: homeostasis model assessment of beta-cell function (HOMA-beta) | 4, 8, and 12 weeks from baseline | HOMA-beta will be measured using high-performance liquid chromatography and the hexokinase method |
| Changes in blood pressure: response rate of blood pressure | 4, 8, and 12 weeks from baseline | 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 |
| Changes in blood pressure: mean sitting diastolic blood pressure | 4, 8, and 12 weeks from baseline | 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 |
| Changes in blood pressure: pulse pressure | 4, 8, and 12 weeks from baseline | 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 |
| Changes in blood pressure: percentage of normalized blood pressure | 4, 8, and 12 weeks from baseline | 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 |
| Changes in blood pressure: mean sitting systolic blood pressure | 4, 8, and 12 weeks from baseline | 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 |
| Changes in glycemic parameter: hemoglobin A1c | 4, 8, and 12 weeks from baseline | HbA1c will be measured |
Countries
South Korea, Thailand
Contacts
Primary ContactTaehee Han, Dr.
Backup ContactJaewoo Park
Outcome results
None listed