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

NCT06647745 | Recruiting Phase 3

• 1 other identifier: THP-001-031
• Study Type: interventional
• Target: 221
• Locations: 2 countries
• Sites: 2

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.

Conditions

Type 2 Diabetes; Hypertension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Changes in glycemic parameter: hemoglobin A1c

  4, 8, and 12 weeks from baseline

• Changes in glycemic parameter: fasting plasma glucose

  4, 8, and 12 weeks from baseline

• Changes in glycemic parameter: homeostasis model assessment of insulin resistance (HOMA-IR)

  4, 8, and 12 weeks from baseline

• Changes in glycemic parameter: homeostasis model assessment of beta-cell function (HOMA-beta)

  4, 8, and 12 weeks from baseline

• Changes in blood pressure: mean sitting systolic blood pressure

  4, 8, and 12 weeks from baseline

Study Arms (4)

Study group

EXPERIMENTAL

The 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

Drug: THP-00101; Drug: THP-00102; Drug: THP-00106

Control group 1

PLACEBO COMPARATOR

The 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

Drug: THP-00101; Drug: THP-00104; Drug: THP-00105

Control group 2

PLACEBO COMPARATOR

The 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

Drug: THP-00102; Drug: THP-00104; Drug: THP-00106

Exploratory group

OTHER

The 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

Drug: THP-00101; Drug: THP-00103; Drug: THP-00105

Interventions

THP-00101 DRUG

Dapagliflozin 10 mg

Also known as: Forxiga Tab. 10mg

Control group 1; Exploratory group; Study group

THP-00102 DRUG

Telmisartan 80 mg

Also known as: Micardis Tab. 80mg

Control group 2; Study group

THP-00103 DRUG

Telmisartan 40 mg

Also known as: Micardis Tab. 40mg

Exploratory group

THP-00104 DRUG

Placebo of Dapagliflozin 10mg

Also known as: Placebo of Fociga Tab. 10mg

Control group 1; Control group 2

THP-00105 DRUG

Placebo of Telmisartan 80mg

Also known as: Placebo of Micardis Tab. 80mg

Control group 1; Exploratory group

THP-00106 DRUG

Placebo of Telmisartan 40mg

Also known as: Placebo of Micardis Tab. 40mg

Control group 2; Study group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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
• 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)

You may not qualify if:

• 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
• \. Subjects with the following blood pressures measured at screening (V1) and randomization (V2)
• (1) 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
• 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

Sponsors & Collaborators

• THPharm Corp.: lead

Study Sites (2)

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

Seoul, 07345, South Korea

RECRUITING

Thammasat University Hospital

Pathum Thani, Changwat Pathum Thani, 12120, Thailand

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Interventions

dapagliflozin; Telmisartan

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Taehee Han, Dr.

CONTACT

827086572278; admin@thpharm.co.kr

Jaewoo Park

CONTACT

827086572278; jw.park@thpharm.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: April 10, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

KR (1); TH (1)