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

FARXIGA 5 mg and 10 mg Initial Monotherapy

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REDUCTION IN A1C LEVELS1

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

Mean reduction in A1C levels with FARXIGA® (dapagliflozin) at 24 weeks
Mean A1C reductions with Farxiga™ (dapagliflozin) at 24 weeks

aP<0.0001 vs placebo.

BL=baseline.

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

 

STUDY DESIGN1,2

FARXIGA 5 mg and 10 mg Initial Monotherapy

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

Randomization with FARXIGA 5 mg (n=64),  FARXIGA 10 mg (n=70),  Dapagliflozin 2.5mg (n=65), Placebo (n=75)
Randomization with FARXIGA 5 mg (n=68),  FARXIGA 10 mg (n=76),  Dapagliflozin 2.5mg (n=67)

*Patients in the main cohort received FARXIGA in the morning. Patients in exploratory cohort received FARXIGA in the evening. (Results from the exploratory cohort are not reported in this summary.)

Dapagliflozin 2.5 mg is not an FDA-approved dose; thus, data from this treatment group are not presented.

Study Objective

Evaluate the efficacy and safety of FARXIGA in treatment-naïve adult patients whose hyperglycemia was inadequately controlled with diet and exercise alone.

 

Study Length

24 weeks

 

 

Key Inclusion Criteria

Treatment-naïve subjects were 18 to 77 years of age with type 2 diabetes who had a BMI of ≤45 kg/m2 and fasting C-peptide >1.0 ng/mL. Subjects in the main cohort included treatment-naïve patients with an A1C between ≥7.0% and ≤10.0%.

 

 

Study Dosing

Patients were randomized to FARXIGA 5 mg or FARXIGA 10 mg once daily in either the morning (QAM, main cohort) or evening (QPM), or placebo.

FARXIGA tablets shown are not actual sizes.

Primary End Point

Change in A1C from baseline at Week 24 in main cohort