Dapagliflozin, Cardio-Metabolic Risk Factors and Type-2 Diabetes

PHASE4UnknownINTERVENTIONAL
Enrollment

186

Participants

Timeline

Start Date

December 22, 2017

Primary Completion Date

December 31, 2018

Study Completion Date

January 31, 2019

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Dapagliflozin 10mg

"The subjects in this arm will receive dapagliflozin (10mg daily) as add-on to metformin therapy (doses ranging from 1500 to 3000 mg daily).~Number of patients to be randomized: 93~Number of patients expected to complete the study: \>87~All the other medications (including lipid-lowering, anti-hypertensive and anti-platelet agents) will be maintained at fixed doses during the treatment."

DRUG

Metformin

"All the subjects in this arm will be on metformin therapy only (doses ranging from 1500 to 3000 mg daily).~Number of patients to be randomized: 93~Number of patients expected to complete the study: \>87~All the other medications (including lipid-lowering, anti-hypertensive and anti-platelet agents) will be maintained at fixed doses during the treatment."

Trial Locations (1)

90127

University Hospital of Palermo, Palermo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

University of Catania

OTHER

lead

University of Palermo

OTHER