Study to Asses the Effect of Dapagliflozin on Central Blood Pressure Reduction.

• Status: Unknown status
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This superiority of central pressure versus peripheral measures to predict cardiovascular events has also been reported in general population or in elder people

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IInstituto Gallego de Medicina Vascular
• Treatments: Dapagliflozin; Glimepiride

Criteria

Inclusion Criteria:

• T2DM subjects with uncontrolled glycaemia, based on HbA1c levels (10% ≥ HbA1c ≥ 7%) at Visit 1.

• Patients may be treated for >3 months with a stable doses of metformin at optimal doses tolerated.

• Participants will be able to give and sign informed consent form.

• Age > 18 years of either gender.

Exclusion Criteria:

• Patients with two or more different oral antihyperglycemic agents.

• HbA 1c levels > 10%.

• Systolic BP >160 mm Hg and/or diastolic BP > 100 mm Hg before randomization.

• History of diabetic ketoacidosis, T1DM, pancreas or beta-cell transplantation or diabetes secondary to any condition.

• History of one or more severe hypoglycaemic episode within 6 months before screening.

• Myocardial infarction, unstable angina pectoris, congestive heart failure, life threatening arrhythmia, history of cerebrovascular accident within 3 months.

• 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.

• 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

• Existence of any serious systemic disease

• Allergic history to the compounds of study medication

• Can not comply the study protocol or misunderstand the informed consent form

• 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.

• Pregnant or breast-feeding or planning to become pregnant during the study.

• History of alcohol abuse (>350 g/week) within 3 years before screening.

• Concurrent therapy with medications that could be affect glycaemia (e.g. corticosteroids) or disallowed therapy (e.g. digoxin).

• Investigational drug treatment within the past 4 months

• Concomitant psychiatric diseases and/or habit/abuse of psychoactive substances

• Predictable lack of co-operation

• Shifts workers

• Employees of the investigator or study centre.