BridgeMD
Tests treatment safety and results for Type 2 Diabetes
Official 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
ClinicalTrials.gov ID: NCT06647745
What this study is testing
What is THP-00101?
THP-00101 is an investigational medicine, being studied as a potential treatment for type 2 diabetes.
Also referred to as Forxiga Tab. 10mg.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- [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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Screening (V1)
- Adult males and females aged 19 (the legal adult age of each country) and above on the date of written informed consent
- people with type 2 diabetes mellitus accompanied by essential hypertension
- people 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%
You likely can't join if
- of screening (V1) when evaluating eligibility again at baseline (V2) 6. people with compliance of 70% or higher with the investigational product...
- Extension Period
- people who have completed all procedures of the treatment period. people who are unsuitable to participate in the study of the extension period...
- people who received a sufficient explanation of the objectives and content of the extension period study and voluntarily provided written informed...
- MSDBP ≥110 mmHg (2) people with the following difference in mean blood pressure measured three times consecutively in each arm at least 2 minutes...
- Mild to severe hepatic impairment
See the full eligibility criteria
Who can join
- Screening (V1)
- Adult males and females aged 19 (the legal adult age of each country) and above on the date of written informed consent
- people with type 2 diabetes mellitus accompanied by essential hypertension
- people 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 people who did not use oral hypoglycemic agents within 8 weeks from screening and people who took metformin monotherapy or dual combination therapy that included metformin for 8 weeks or longer from screening...
- 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...
- Baseline (V2) 1\. people 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. people with the following MSSBP measured...
What rules you out
- of screening (V1) when evaluating eligibility again at baseline (V2) 6. people with compliance of 70% or higher with the investigational product during the run-in period
- Extension Period
- people who have completed all procedures of the treatment period. people who are unsuitable to participate in the study of the extension period, considering safety, etc., can be excluded.
- people who received a sufficient explanation of the objectives and content of the extension period study and voluntarily provided written informed consent Exclusion Criteria: 1\. people with the following blood...
- MSDBP ≥110 mmHg (2) people with the following difference in mean blood pressure measured three times consecutively in each arm at least 2 minutes apart at screening (V1): MSSBP ≥20 mmHg and MSDBP ≥10 mmHg 2. people with...
- Mild to severe hepatic impairment
- Biliary obstruction or cholestasis
- AST or ALT ≥2 x ULN
- Total bilirubin \>2 x ULN
- Patients with moderate (stage 3b) or severe renal impairment (eGFR by IDMS-MDRD \<45 mL/min/1.73 m2)
- Acute conditions that may affect renal function, such as dehydration, severe infection, cardiovascular collapse (shock), and sepsis
- Diabetic precoma and coma
- Severe infection or severe traumatism
- Malnutrition, starvation, debilitation, pituitary insufficiency, or adrenal dysfunction
- Acute or chronic diseases that may cause tissue hypoxia such as respiratory failure (pulmonary infarction and severe pulmonary dysfunction) and shock, and gastrointestinal disorders including dehydration, diarrhea, and...
- Orthostatic hypotension with symptoms
- Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmia considered clinically significant as judged by the investigator
- Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve stenosis
- Wasting diseases, autoimmune diseases, and connective tissue diseases
- Dysuria, anuria, oliguria, and ischuria that cannot be controlled by drugs
- Gastrointestinal diseases that may affect the absorption of the investigational product (gastrointestinal ulcer, gastritis, gastric spasm, gastroesophageal reflux disease, Crohn's disease, etc.)
- people who are HBsAg positive§ or HCV antibody positive∥ §people who are taking antiviral products stably may participate ∥people with negative HCV RNA test results may participate
- people who are positive for HIV Ag/Ab combo test 4. people with the following past medical history
- Hereditary angioedema or angioedema caused by ACE inhibitor or angiotensin II antagonist treatment.
- Hereditary problems such as galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption, etc.
- Type 1 diabetes mellitus, secondary diabetes mellitus, lactic acidosis, acute or chronic metabolic acidosis, and ketoacidosis including diabetic ketoacidosis accompanied or not accompanied by coma
- Drug abuse or alcohol abuse
- Past medical history of secondary hypertension or all medical history suspected of secondary hypertension (not limited to the following: coarctation of aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's...
- Severe cardiac failure (NYHA class III and IV), ischemic heart disease (unstable angina and myocardial infarction), and peripheral vascular diseases that occurred within 24 weeks before screening (V1)
- Severe cerebrovascular diseases (stroke, cerebral infarction, cerebral hemorrhage, etc.) that occurred within 24 weeks before screening (V1)
- Moderate or malignant retinopathy that occurred within 24 weeks before screening (V1) (retinal hemorrhage, visual disturbance, and retinal microaneurysm that occurred within the last 24 weeks)
- Urinary tract infection or genital infection that occurred within 16 weeks before screening (V1)
- Malignant tumors that occurred within the last 5 years. people who experienced no recurrence for at least 5 years after being declared cured or in the cases of basal cell carcinoma, squamous cell carcinoma of the skin...
- Bariatric surgery or lap-band surgery within 12 months before screening (V1)
- Percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery within 24 weeks before screening (V1)
- Antiobestic drugs or drugs based on the investigator's judgment to be capable of having significant effects on weight control within 12 weeks before screening (V1)
- Systemic corticosteroids used for 2 weeks or longer, within 8 weeks before screening (V1) (inhaled and topical agents, eye drops, intranasal, intra-articular administration, and other localized administrations are...
- Insulin injections or GLP-1 receptor agonists administered for more than 7 days consecutively or non-consecutively within 8 weeks before screening (V1)
- Current treatment by the triple combination of antihypertensive agents, or current treatment by the dual combination including high-dose amlodipine (10 mg)
- Current treatment by the monotherapy of hypoglycemic agents except metfomin or current treatment by the triple combination including metformin
- Current treatment with drugs containing aliskiren
- people currently receiving dialysis
- Scheduled tests involving the intravenous administration of radiographic iodinated contrast agents from 48 hours before the run-in period until the end of the study (e.g., intravenous urography, intravenous angiography...
- Hormonal contraceptives (oral products, injections, implants, etc.)
- IUD or IUS
- Male or female sterilization (e.g., vasectomy, hysterectomy, bilateral oophorectomy, bilateral salpingectomy, etc.)
- Dual methods: Simultaneous use of 1) to 3) methods and the barrier method¶ or simultaneous use of double barrier methods# (simultaneous use of cap/diaphragm and male condom) and the spermicide
- Sexual abstinence: It is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. However, if the age, job...
- Male condom, female condom, cap, diaphragm, sponge, etc. #However, simultaneous use of male condoms and female condoms is not allowed 11. people unsuitable to participate in this study based on the investigator's...
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
- Pathum Thani, Changwat Pathum Thani, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea; Pathum Thani, Changwat Pathum Thani, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.