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

Inclusion Criteria:

• Screening (V1)

1. Adult males and females aged 19 (the legal adult age of each country) and aboveon 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 fromscreening and subjects who took metformin monotherapy or dual combinationtherapy 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 140mmHg

• 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 eacharm at screening (V1) (If the MSSBP is the same between both arms, then the arm withthe higher mean sitting diastolic blood pressure (MSDBP) is selected as thereference arm.)

***Classified based on whether antihypertensive agents were administered within 4weeks from screening (V1) 5 Subjects considered by the investigator appropriate todiscontinue the use of oral hypoglycemic agents and antihypertensive agents, otherthan the existing metformin, during the study (with metformin maintained at aminimum of 1,000 mg/day) 6 Subjects who received a sufficient explanation of theobjectives and content of the study and voluntarily provided written informedconsent

• Baseline (V2)

1. Subjects with the following HbA1c and FPG levels at baseline (V2) - HbA1c lessthan 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 oralhypoglycemic 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 takeantihypertensive agents for at least 2 weeks before baseline (V2) 5. Subjects withno disqualifying inclusion/exclusion criteria of screening (V1) when evaluatingeligibility again at baseline (V2) 6. Subjects with compliance of 70% or higher withthe investigational product during the run-in period

• Extension Period

1. Subjects who have completed all procedures of the treatment period. Subjectswho 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 ofthe extension period study and voluntarily provided written informed consent

Exclusion Criteria:

1. Subjects with the following blood pressures measured at screening (V1) andrandomization (V2)

(1) Subjects with the following MSDBP measured in the reference arm

• MSDBP ≥110 mmHg (2) Subjects with the following difference in mean blood pressuremeasured 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

1. Mild to severe hepatic impairment

2. Biliary obstruction or cholestasis

3. AST or ALT ≥2 x ULN

4. Total bilirubin >2 x ULN

5. Patients with moderate (stage 3b) or severe renal impairment (eGFR by IDMS-MDRD <45 mL/min/1.73 m2)

6. Acute conditions that may affect renal function, such as dehydration, severeinfection, cardiovascular collapse (shock), and sepsis

7. Diabetic precoma and coma

8. Severe infection or severe traumatism

9. Malnutrition, starvation, debilitation, pituitary insufficiency, or adrenaldysfunction

10. Acute or chronic diseases that may cause tissue hypoxia such as respiratoryfailure (pulmonary infarction and severe pulmonary dysfunction) and shock, andgastrointestinal disorders including dehydration, diarrhea, and vomiting

11. Orthostatic hypotension with symptoms

12. Clinically significant ventricular tachycardia, atrial fibrillation, atrialflutter, or other arrhythmia considered clinically significant as judged by theinvestigator

13. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary arterydisease, aortic stenosis, hemodynamically significant aortic valve or mitralvalve stenosis

14. Wasting diseases, autoimmune diseases, and connective tissue diseases

15. Dysuria, anuria, oliguria, and ischuria that cannot be controlled by drugs

16. Gastrointestinal diseases that may affect the absorption of the investigationalproduct (gastrointestinal ulcer, gastritis, gastric spasm, gastroesophagealreflux disease, Crohn's disease, etc.)

17. 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

18. Subjects who are positive for HIV Ag/Ab combo test 4. Subjects with thefollowing past medical history

19. Hereditary angioedema or angioedema caused by ACE inhibitor or angiotensin IIantagonist treatment.

20. Hereditary problems such as galactose intolerance, Lapp lactose deficiency,glucose-galactose malabsorption, etc.

21. Type 1 diabetes mellitus, secondary diabetes mellitus, lactic acidosis, acuteor chronic metabolic acidosis, and ketoacidosis including diabetic ketoacidosisaccompanied or not accompanied by coma

22. Drug abuse or alcohol abuse

23. Past medical history of secondary hypertension or all medical history suspectedof secondary hypertension (not limited to the following: coarctation of aorta,primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome,pheochromocytoma, polycystic kidney disease, etc.)

24. Severe cardiac failure (NYHA class III and IV), ischemic heart disease (unstable angina and myocardial infarction), and peripheral vascular diseasesthat occurred within 24 weeks before screening (V1)

25. Severe cerebrovascular diseases (stroke, cerebral infarction, cerebralhemorrhage, etc.) that occurred within 24 weeks before screening (V1)

26. Moderate or malignant retinopathy that occurred within 24 weeks beforescreening (V1) (retinal hemorrhage, visual disturbance, and retinalmicroaneurysm that occurred within the last 24 weeks)

27. Urinary tract infection or genital infection that occurred within 16 weeksbefore screening (V1)

28. Malignant tumors that occurred within the last 5 years. Subjects whoexperienced no recurrence for at least 5 years after being declared cured or inthe cases of basal cell carcinoma, squamous cell carcinoma of the skin, thyroidcancer, or carcinoma in situ at other sites, subjects who experienced norecurrence for at least 3 years after being declared cured can be enrolledbased on the investigator's medical judgment 5. Subjects who received thefollowing medication or non-pharmacological therapy at screening (V1)

29. Bariatric surgery or lap-band surgery within 12 months before screening (V1)

30. Percutaneous transluminal coronary angioplasty or coronary artery bypass graftsurgery within 24 weeks before screening (V1)

31. Antiobestic drugs or drugs based on the investigator's judgment to be capableof having significant effects on weight control within 12 weeks beforescreening (V1)

32. Systemic corticosteroids used for 2 weeks or longer, within 8 weeks beforescreening (V1) (inhaled and topical agents, eye drops, intranasal,intra-articular administration, and other localized administrations are allowedregardless of duration)

33. Insulin injections or GLP-1 receptor agonists administered for more than 7 daysconsecutively or non-consecutively within 8 weeks before screening (V1)

34. Current treatment by the triple combination of antihypertensive agents, orcurrent treatment by the dual combination including high-dose amlodipine (10mg)

35. Current treatment by the monotherapy of hypoglycemic agents except metfomin orcurrent treatment by the triple combination including metformin

36. Current treatment with drugs containing aliskiren

37. Subjects currently receiving dialysis

38. Scheduled tests involving the intravenous administration of radiographiciodinated contrast agents from 48 hours before the run-in period until the endof the study (e.g., intravenous urography, intravenous angiography, vascularangiography, computed tomography using contrast agents, etc.) 6. Subjects whoare hypersensitive to the active ingredients (dapagliflozin or telmisartan) orother ingredients of the investigational product 7. Subjects with a history ofhypersensitivity to metformin or biguanides 8. Subjects who participated inother clinical trials within 12 weeks before taking the investigational productof this study and were administered (or received) other investigationalproducts (or devices) 9. Pregnant or breastfeeding women 10. Women and men ofchildbearing potential who have plans for pregnancy or do not agree to performappropriate contraception from screening (V1) until 4 weeks after the last doseof the investigational product. The appropriate contraceptive methods for thisstudy are as follows:

39. Hormonal contraceptives (oral products, injections, implants, etc.)

40. IUD or IUS

41. Male or female sterilization (e.g., vasectomy, hysterectomy, bilateraloophorectomy, bilateral salpingectomy, etc.)

42. Dual methods: Simultaneous use of 1) to 3) methods and the barrier method¶ orsimultaneous use of double barrier methods# (simultaneous use of cap/diaphragmand male condom) and the spermicide

43. Sexual abstinence: It is considered a highly effective method only if definedas refraining from heterosexual intercourse during the entire period of riskassociated with the study treatments. However, if the age, job, lifestyle, orsexual orientation of the participant assures contraception according to theinvestigator's decision, strict abstinence from sexual intercourse is alsoallowed. Periodic sexual abstinence (e.g., calendar method, symptothermalmethod, post-ovulation method, etc.) and withdrawal (coitus interruptus) arenot 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 theinvestigator's judgment.