A study of the effect of dapagliflozin on central blood pressure reduction compared in adult subjects with type 2 Diabetes Mellitus and inadequate glycemic control.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. T2DM subjects with uncontrolled glycaemia, based on HbA1c levels (10% = HbA1c = 7%) at Visit 1.
2. Patients may be treated for >3 months with a stable doses of metformin at optimal doses tolerated.
3. Participants will be able to give and sign informed consent form.
4. Age > 18 years of either gender.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 159
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with two or more different oral antihyperglycemic agents.
2. HbA1c levels > 10%.
3. Systolic BP >160 mm Hg and/or diastolic BP > 100 mm Hg before randomization.
4. History of diabetic ketoacidosis, T1DM, pancreas or beta-cell transplantation or diabetes secondary to any condition.
6. History of one or more severe hypoglycaemic episode within 6 months before screening.
7. Myocardial infarction, unstable angina pectoris, congestive heart failure, life threatening arrhythmia, history of cerebrovascular accident within 3 months.
8. Clinically relevant renal disease; defines if serum creatinine equal or lager than 1.5 mg/dl or eGFR < 60 ml/min/1.73m2, at screening.
9. Liver function abnormal: glutamic-oxalacetic transaminase lager than 2 times of upper limit normal or glutamic-pyruvic transaminase lager than 2 times of upper limit normal
10. Existence of any serious systemic disease
11. Allergic history to the compounds of study medication
12. Can not comply the study protocol or misunderstand the informed consent form
13. Women of childbearing potential will be required to use a double-barrier method of birth control throughout study participation. Women who are surgically sterile or documented post-menopausal for at least 2 years are not considered to be of childbearing potential.
14. Pregnant or breast-feeding or planning to become pregnant during the study.
15. History of alcohol abuse (>350 g/week) within 3 years before screening.
16. Concurrent therapy with medications that could be affect glycaemia (e.g. corticosteroids) or disallowed therapy (e.g. digoxin).
17. Investigational drug treatment within the past 4 months
18. Concomitant psychiatric diseases and/or habit/abuse of psychoactive substances
19. Predictable lack of co-operation
20. Shifts workers
21. Employees of the investigator or study centre.