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A TREATMENT FOR ADULTS WITH TYPE 2 DIABETES MELLITUS, IN ADDITION TO DIET AND EXERCISE

FARXIGA 5 mg Initial Combination Therapy With Metformin XR

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SIGNIFICANT REDUCTION IN A1C LEVELS WITH 5 MG DOSE1

Primary end point: Mean reduction in A1C levels at 24 weeks1,2,a

Mean A1C level reduction with FARXIGA® (dapagliflozin) 5 mg + metformin XR or monotherapy at 24 weeks
Mean A1C reductions with Farxiga™ (dapagliflozin) 5 mg + metformin XR or monotherapy at 24 weeks

aThe median metformin XR dose was 2000 mg per day.

bP<0.0001 vs FARXIGA 5 mg or metformin XR.

BL=baseline.

Values are last observation (prior to rescue for rescued patients) carried forward and represent adjusted mean change from baseline.

 

SIGNIFICANT WEIGHT REDUCTION WITH 5 MG DOSE1

A secondary end point: Mean weight reduction at 24 weeks1,2,c

Mean weight reductions with FARXIGA 5 mg + metformin XR or monotherapy at 24 weeks
Mean weight reductions with FARXIGA 5 mg + metformin XR or monotherapy at 24 weeks

cThe median metformin XR dose was 2000 mg per day.

dP<0.0001 vs metformin XR.

BL=baseline.

Values are last observation (prior to rescue for rescued patients) carried forward and represent adjusted mean change from baseline.

FARXIGA is not indicated for weight loss.

*Weight reduction was a secondary end point.

 

STUDY DESIGN1,2

FARXIGA 5 mg Initial Combination Therapy With Metformin XR

Randomized, double-blind, active-controlled, multicenter, 24-week, phase 3 trial

Randomization with FARXIGA 5 mg + metformin XR (n=194),  FARXIGA 5 mg + placebo (n=203),  Metformin XR + placebo (n=201)

Study Objective

Evaluate the efficacy and safety of FARXIGA plus metformin XR in treatment-naïve adult patients whose type 2 diabetes cannot be controlled with diet and exercise alone.

 

Study Length

24 weeks

 

 

Key Inclusion Criteria

Patients were 18 to 77 years of age with type 2 diabetes who had inadequate glycemic control (A1C ≥7.5% and ≤12.0%) and had a C-peptide ≥0.33 nmol/L and a body mass index (BMI) ≤45 kg/m2.

 

 

Study Dosing

FARXIGA in combination and as monotherapy was dosed at 5 mg. The metformin XR dose was up-titrated weekly in 500-mg increments, as tolerated, up to a maximum of 2000 mg daily. Mean metformin XR dose was 1773.5 mg in the combination group and 1843.6 mg for the metformin XR monotherapy group.

FARXIGA tablet shown is not actual size.

Primary End Point

Change in A1C from baseline at Week 24

Select Secondary End Point

  • Change in total body weight from baseline at Week 24