Type 2 Diabetes Mellitus
Conditions
Interventions
Trade Name: Dapagliflozin
Pharmaceutical Form: Tablet
INN or Proposed INN: Dapagliflozin
CAS Number: 461432-26-8
Other descriptive name: DAPAGLIFLOZIN
Concentration unit: mg milligram(s)
Concentration
Sponsors
Instituto Gallego de Medicina Vascular (IGAMEVAS S.L.)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Patients with two or more different oral antihyperglycemic agents. 2. HbA 1c 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 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): change from baseline in cPP, AI, AP, 24-hour ambulatory systolic/diastolic BP;Timepoint(s) of evaluation of this end point: Screening, Day 1, week 4, week 12, week 24, week 28 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control regarding central systolic blood pressure estimated by applanation tonometry.;Secondary Objective: 1.To assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control. 2.To assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control regarding central pulse pressure estimated by applanation tonometry. 3.To assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control regarding augmentation pressure and augmentation index estimated by applanation tonometry. 4.To assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control regarding 24 hours ambulatory systolic/diastolic blood pressure. 5.To assess the safety and tolerability of dapagliflozin relative to glimepiride.;Primary end point(s): to assess central blood pressures reduction between dapagliflozin 10 mgrs and glimepiride 4 mgrs.;Timepoint(s) of evaluation of this end point: Change from baseline in cPP, AI, AP, 24-hour ambulatory systolic/diastolic BP | — |
Countries
Spain
Contacts
Public ContactIGAMEVAS SL
Instituto Gallego de Medicina Vascular (IGAMEVAS S.L.)
Outcome results
None listed