Impact on Glycemic Variability in Newly Onset T2DM Patients Initiating Dapagliflozin Plus Metformin Versus Metformin Alone

PHASE3CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

October 27, 2019

Primary Completion Date

March 6, 2021

Study Completion Date

March 30, 2021

Conditions
Type 2 Diabetes
Interventions
DIAGNOSTIC_TEST

Continuous glucose monitoring

"Subjects enrolled will be randomized 1:1 to either receive a daily dosage of dapagliflozin 10 mg and 2000 mg metformin for 12 weeks or 2000 mg metformin. Patients who do not tolerate metformin at 2000mg dose will be downtitrated to 1500 mg daily. In case patients do not tolerate 1500 mg daily, they will be excluded.~Both groups will be monitored for 7 days using either iPro™ CGM system (Medtronic, Northridge, CA) or Dexcom G6 CGM (Dexcom Inc, San Diego, CA). Basal continuous glucose monitoring will start at week 1 (first visit), and removed at day 7 and final continuous glucose monitoring will start at week 11 and removed 7 days after (final visit)."

Trial Locations (1)

14080

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán ''INCMNSZ'', Mexico City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER