None listed
Conditions
Interventions
Patients in this study will be treated with AD-4833-536 (Azilsartan-Pioglitazone) tablets, in a dose of 30 mg + 20 mg, PO, QD for 4 weeks. From this point until week 52 of treatment the dose of the study drug can be changed according to the clinical response, being able to adopt doses such as: 30 mg + 40 mg, 45 mg + 40 mg and XX mg + 40 mg.
Sponsors
TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject is male or female and is 18 years of age or older. 2. Subject has type 2 diabetes with a hemoglobin A1C ≥ 7.0% at ≤ 11.0% at the time of selection. 3. Subject has hypertension with diastolic blood pressure (DBP) ≥ 80 mm Hg and ≤ 114 mm Hg and with systolic blood pressure (SBP) ≥ 130 mm Hg and <185 mm Hg at Screening and Visit 2. 4. The subject has followed a stable anti-diabetic diet and exercise program and / or received ≤ two (2) antiglycemic agents for a minimum of 8 weeks before the Selection. 5. If the subject is receiving antihypertensive therapy, he / she must receive ≤ two (2) antihypertensive agents and must be in a stable regimen for a minimum of 8 weeks before the Selection. 6. At the time of the selection, the subject has clinical laboratory evaluations within the range. 7. The subject is able to understand and comply with the requirements of the protocol. 8. The subject or the legal representative of the patient signs a written informed consent form before performing any study procedure. 9. A subject with potential to become pregnant who is sexually active, agrees to use an appropriate method of contraception from the Selection and throughout the study.
Exclusion criteria
Exclusion criteria: 1. The subject is currently taking, or is expected to take, TZDs within 12 weeks prior to the Selection. 2. The subject has hypersensitivity to the TZDs. 3. The subject is currently taking an angiotensin II receptor blocker (ARB II) and is not willing to suspend the medication at Visit 2. 4. Subject has hypersensitivity to ARB II. 5. Subject has unstable angina or heart failure of any etiology with functional class III or IV of the NYHA. 6. Subject has a history of myocardial infarction (MI), cerebrovascular accident (CVA), percutaneous coronary intervention (PCI), aortocoronary bypass (AB) or transient ischemic attack (TIA) within the previous six months. 7. The subject has clinically significant defects in cardiac conduction. 8. Subject has secondary hypertension of any etiology. 9. The subject has a body mass index (BMI)> at 45 kg / m2. 10. The subject has moderate to severe renal insufficiency. 11. The subject has anemia. 12. The subject has unexplained hematuria at the time of the selection, confirmed by repeated examination. 13. The patient has triglycerides> 600 mg / dL at the time of selection. 14. The subject has hyperkalemia. 15. At the time of Screening, the subject has a level of alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times above the ULN, active liver disease or jaundice. 16. The subject has a history of drug abuse or a history of alcohol abuse within the last 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Evaluation of the PA in each visit, having as objective a value lower than 130/80 mm Hg. Criterion 2: Serum levels of HbA1c, targeting a value less than 7.0%. Measure:1) Changes in blood pressure (BP) values from baseline. 2) Changes in the values of glycosylated hemoglobin (HbA1c) from baseline. Timepoints:PA: Day 1 and weeks 4, 8, 12, 16, 24, 32, 40, 48 and 52. HbA1c: Day 1 and weeks 4, 8, 12, 16, 24, 40 and 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Evaluation of any harmful medical manifestation in a clinical research subject to whom a pharmaceutical product was administered. Criterion 2: Panels of hematology and serum chemistry, urinalysis. Criterion 3: Physical examination of (1) eyes, (2) ears, nose and throat, (3) cardiovascular system, (4) respiratory system, (5) digestive system, (6) dermatological system, (7) extremities, ( 8) musculoskeletal system, (9) nervous system, (10) lymph nodes and (11) others. Criterion 4: Subjects will be weighed and measured wearing light clothing and without shoes. The height must be documented in centimeters. The BMI will be calculated based on weight and height. Criterion 5: PA and pulse after a rest of 5 min. Measure:Security: 1) Emerging Adverse Events. 2) Laboratory results. 3) Physical examination. 4) Weight, height and BMI. 5) Vital signs. Timepoints:1) Adverse Events, weight, height, BMI, vital signs: Day 1 and weeks 4, 8, 12, 16, 24, 32, 40, 48 and 52. 2) Laboratory: Day 1 and weeks 4, 12, 24, 40 and 52. 3) Physical exam: Before starting the treatment and in week 52. | — |
Countries
Argentina, Chile, Mexico, Peru, United States
Contacts
Public ContactEduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed