Status:
UNKNOWN
Dapagliflozin, Cardio-Metabolic Risk Factors and Type-2 Diabetes
Lead Sponsor:
University of Palermo
Collaborating Sponsors:
AstraZeneca
University of Catania
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
Dapagliflozin is a member of the sodium-glucose cotransporter-2 (SGLT2) inhibitor class antidiabetes agents which produces significant and sustained reductions in glycemic parameters in patients with ...
Detailed Description
The investigators will perform an open label, two-arms, prospective intervention study using dapagliflozin+metformin vs. metformin alone for a period of 6 months in patients with T2DM. The research h...
Eligibility Criteria
Inclusion
- men and women with T2DM;
- age \>18;
- BMI ≥20 kg/m\^2;
- HbA1c 7.0-9.0 %;
- receiving metformin therapy at least 1500 mg/day for at least 8 weeks before screening;
- plasma triglycerides \<400 mg/dL, plasma LDL-cholesterol \< 250 mg/dL;
- stabile daily dose(s) of hypolipidemic drugs (statins, ezetimibe) for at least 7 weeks prior to the day of randomization;
- adequately controlled blood pressure (≤140/90 mmHg) to be maintained during the study according to Standard of Care;
- able to swallow whole tablets.
Exclusion
- pregnancy or willingness to became pregnant;
- severe liver dysfunction (alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 3 times upper limit of normal);
- renal failure with glomerular filtration rate (eGFR) \<60 ml/min/1.73m\^2;
- major cardiovascular event (myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack) within 12 weeks before screening;
- severe infections (such as HIV and HCV);
- any malignancy within 5 years before screening.
Key Trial Info
Start Date :
December 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2019
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT03377335
Start Date
December 22 2017
End Date
January 1 2019
Last Update
February 26 2018
Active Locations (1)
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1
University Hospital of Palermo
Palermo, Italy, 90127