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

Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study ID
NCT04090580
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 77 Years
Healthy Volunteers
Not accepted

Interventions

  • Continuous glucose monitoring — DIAGNOSTIC_TEST
    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).

Study Details

This study will compare the effect of Dapagliflozin added to Metformin vs Metformin alone on blood sugar fluctuations of adults with a recent diagnosis of Type 2 Diabetes (T2D). The duration of the protocol will be 12 weeks. Continuous glucose monitoring will be measured before and at the end of the intervention. The questions this protocol will answer include: * Is there a difference in blood sugar fluctuations when Dapagliflozin is added to Metformin compared with Metformin alone in adults with type 2 Diabetes? * Does Dapagliflozin added to Metformin improve blood glucose control in patients with type 2 Diabetes?

Key Dates

Start date
Oct 27, 2019
Status verified
May 2025
Primary completion
Mar 6, 2021
Completion
Mar 30, 2021

Study Design

Enrollment
88 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DAPAGLIFLOZIN 10 mg/day + METFORMIN 2000 mg/day for 12 weeks
    Subjects enrolled will be randomized 1:1 to receive a daily dosage of 10 mg dapagliflozin and 2000 mg metformin for 12 weeks
  • Active Comparator: METFORMIN 2000 mg/day for 12 weeks
    Subjects enrolled will be randomized 1:1 to receive a daily dosage of 2000 mg Metformin for 12 weeks

Primary Outcome Measure

ΔHbA1c [ Time Frame: 12 weeks ]

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