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Type 2 DiabetesPhase 3THP-001-031NCT06647745

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

A Phase 3 study testing THP-00101, THP-00102 and THP-00103 in people with Type 2 Diabetes and Hypertension, run by THPharm Corp. at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Type 2 Diabetes, Hypertension
What is being tested?
THP-00101, THP-00102 and THP-00103
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
221 participants
Where
2 sitesin 2 countries
Study dates
10 Apr 2025to 1 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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
  • Subjects with type 2 diabetes mellitus accompanied by essential hypertension
  • 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
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  • 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
  • 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.
  • Subjects who received a sufficient explanation of the objectives and content of the extension period study and voluntarily provided written informed consent

Who cannot join

  • 1. Subjects with the following blood pressures measured at screening (V1) and randomization (V2)
  • Subjects with the following MSDBP measured in the reference arm
  • MSDBP ≥110 mmHg (2) Subjects 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. Subjects with a BMI of >35 kg/m2 3. Subjects with the following comorbidities or conditions
  • Mild to severe hepatic impairment
  • Biliary obstruction or cholestasis
  • AST or ALT ≥2 x ULN
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  • 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 vomiting
  • 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.)
  • Subjects who are HBsAg positive§ or HCV antibody positive∥
  • §Subjects who are taking antiviral products stably may participate
  • ∥Subjects with negative HCV RNA test results may participate
  • Subjects who are positive for HIV Ag/Ab combo test 4. Subjects 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 syndrome, pheochromocytoma, polycystic kidney disease, etc.)
  • 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. Subjects 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, thyroid cancer, or carcinoma in situ at other sites, subjects who experienced no recurrence for at least 3 years after being declared cured can be enrolled based on the investigator's medical judgment 5. Subjects who received the following medication or non-pharmacological therapy at screening (V1)
  • <!-- -->
  • 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 allowed regardless of duration)
  • 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
  • Subjects 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, vascular angiography, computed tomography using contrast agents, etc.) 6. Subjects who are hypersensitive to the active ingredients (dapagliflozin or telmisartan) or other ingredients of the investigational product 7. Subjects with a history of hypersensitivity to metformin or biguanides 8. Subjects who participated in other clinical trials within 12 weeks before taking the investigational product of this study and were administered (or received) other investigational products (or devices) 9. Pregnant or breastfeeding women 10. Women and men of childbearing potential who have plans for pregnancy or do not agree to perform appropriate contraception from screening (V1) until 4 weeks after the last dose of the investigational product. The appropriate contraceptive methods for this study are as follows:
  • <!-- -->
  • 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, lifestyle, or sexual orientation of the participant assures contraception according to the investigator's decision, strict abstinence from sexual intercourse is also allowed. Periodic sexual abstinence (e.g., calendar method, symptothermal method, post-ovulation method, etc.) and withdrawal (coitus interruptus) are not acceptable methods of contraception.
  • Male condom, female condom, cap, diaphragm, sponge, etc. #However, simultaneous use of male condoms and female condoms is not allowed 11. Subjects unsuitable to participate in this study based on the investigator's judgment.

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Taehee Han, Dr. contact

827086572278

admin@thpharm.co.kr

Jaewoo Park contact

827086572278

jw.park@thpharm.co.kr

2 sites in 2 countries

South Korea1 site, 1 recruiting

  • The Catholic University of Korea, Yeouido ST. Mary's Hospital

    Seoul, 07345

    Hyuk-Sang Kwon, Dr.

    Recruiting

Other trials in South Korea

Thailand1 site, 1 recruiting

  • Thammasat University Hospital

    Pathum Thani, Changwat Pathum Thani, 12120

    Thipaporn Tharavani, Dr.

    Not yet recruiting

Other trials in Thailand

About this study

[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.

Being tested
THP-00101, THP-00102, THP-00103, THP-00104, THP-00105
Medical subject headings
Diabetes Mellitus, Type 2, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • THP-00101Drug

    Also called Forxiga Tab. 10mg

    Dapagliflozin 10 mg

  • THP-00102Drug

    Also called Micardis Tab. 80mg

    Telmisartan 80 mg

  • THP-00103Drug

    Also called Micardis Tab. 40mg

    Telmisartan 40 mg

  • THP-00104Drug

    Also called Placebo of Fociga Tab. 10mg

    Placebo of Dapagliflozin 10mg

  • THP-00105Drug

    Also called Placebo of Micardis Tab. 80mg

    Placebo of Telmisartan 80mg

  • THP-00106Drug

    Also called Placebo of Micardis Tab. 40mg

    Placebo of Telmisartan 40mg

Study groups in NCT06647745
Study groupRoleWhat they receive
Study groupExperimentalThe participant will receive the investigational drugs THP-00101 (Dapagliflozin 10 mg), THP-00102 (Telmisartan 80 mg), and a placebo for THP-00103 once a day by per oral over 12 weeks
Receives: Drug: THP-00101; Drug: THP-00102; Drug: THP-00106
Control group 1Placebo comparatorThe participant will receive the investigational drugs THP-00101 (Dapagliflozin 10 mg), Placebo of THP-00102, and Placebo of THP-00103 once a day by per oral over 12 weeks
Receives: Drug: THP-00101; Drug: THP-00104; Drug: THP-00105
Control group 2Placebo comparatorThe participant will receive the investigational drugs Placebo of THP-00101, THP-00102 (Telmisartan 80 mg), and Placebo of THP-00103 once a day by per oral over 12 weeks
Receives: Drug: THP-00102; Drug: THP-00104; Drug: THP-00106
Exploratory groupOtherThe participant will receive the investigational drugs THP-00101 (Dapagliflozin 10 mg), Placebo of THP-00102, and THP-00103 (Telmisartan 40 mg) once a day by per oral over 12 weeks
Receives: Drug: THP-00101; Drug: THP-00103; Drug: THP-00105

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Hemoglobin A1c (HbA1c)

    The Hemoglobin A1c will be measured using the high-performance liquid chromatography (HPLC) method.

    Measured: 12 weeks

  2. 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

    Measured: 12 Weeks

Secondary outcomes (9)

  1. Changes in glycemic parameter: hemoglobin A1c

    HbA1c will be measured

    Measured: 4, 8, and 12 weeks from baseline

  2. Changes in glycemic parameter: fasting plasma glucose

    FPG will be measured

    Measured: 4, 8, and 12 weeks from baseline

  3. 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.

    Measured: 4, 8, and 12 weeks from baseline

  4. 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

    Measured: 4, 8, and 12 weeks from baseline

  5. 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

    Measured: 4, 8, and 12 weeks from baseline

  6. 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

    Measured: 4, 8, and 12 weeks from baseline

  7. 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

    Measured: 4, 8, and 12 weeks from baseline

  8. 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

    Measured: 4, 8, and 12 weeks from baseline

  9. 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

    Measured: 4, 8, and 12 weeks from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2024
  2. Study start10 Apr 2025
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
221 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06647745
Sponsor's protocol ID
THP-001-031
Acronym
THP-001-031
Status last verified
Sep 2025
First submitted
16 Oct 2024
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing THP-00101, THP-00102 and THP-00103 in people with Type 2 Diabetes and Hypertension, run by THPharm Corp. at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Taehee Han, Dr. (827086572278, admin@thpharm.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Hemoglobin A1c (HbA1c) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06647745.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.

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