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

FARXIGA as Add-On to Sitagliptin (a DPP-4i)

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SIGNIFICANT REDUCTION IN A1C LEVELS1

Primary end point: Mean reduction in A1C levels with FARXIGA + sitagliptin + metformin at 24 weeks1

Primary end point: Mean reduction in A1C levels with FARXIGA® (dapagliflozin) + sitagliptin + metformin at 24 weeks
Primary end point: Mean A1C reductions with Farxiga™ (dapagliflozin) + sitagliptin + metformin at 24 weeks

aP<0.0001 vs placebo + sitagliptin ± metformin.

BL=baseline.

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

 

SIGNIFICANT WEIGHT REDUCTION1

A secondary end point: Mean weight reduction with FARXIGA + sitagliptin ± metformin at 24 weeks1

Secondary end point: Mean weight reductions with FARXIGA + sitagliptin ± metformin at 24 weeks
Secondary end point: Mean weight reductions with FARXIGA + sitagliptin ± metformin at 24 weeks

bP<0.0001 vs placebo + sitagliptin ± metformin.

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 as Add-On to Sitagliptin (a DPP-4i)

Randomized, double-blind, placebo-controlled, multicenter, parallel-group, 24-week, phase 3 study

Randomization with FARXIGA 10 mg + sitagliptin 100 mg ± metformin ≥1500 mg (n=225),  Placebo + sitagliptin 100 mg ± metformin ≥1500 mg (n=226)

Patients were stratified into 2 groups: those treated with metformin and those not treated with metformin.

Study Objective

Evaluate the efficacy and safety of FARXIGA in adult patients with inadequate glycemic control on sitagliptin with/without metformin.

 

Study Length

24 weeks

 

 

Key Inclusion Criteria

Patients were ≥18 years of age with type 2 diabetes who were DPP-4i treatment-naïve and had an A1C of 7.7% to 10.5% or were DPP-4i treated with an A1C of 7.2% to 10.0%. A1C prior to randomization was ≥7.0% to ≤10.0%. Patients had systolic blood pressure (SBP) <160 mm Hg and/or a diastolic blood pressure (DBP) <100 mm Hg at randomization.

 

 

Study Dosing

Eligible patients were stratified based on the presence or absence of background metformin (≥1500 mg per day) and within each stratum were randomized to either FARXIGA 10 mg plus sitagliptin 100 mg once daily, or placebo plus sitagliptin 100 mg.

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 to Week 24