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

FARXIGA as Add-On Therapy to Metformin

Select a category or scroll  to learn more.

 

SIGNIFICANT REDUCTION IN A1C LEVELS1

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

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

aP<0.0001 vs placebo + 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 + metformin at 24 weeks1,2

Chart shows secondary end point mean weight  reductions with FARXIGA + metformin at 24 weeks
Secondary end point mean weight  reductions with FARXIGA + metformin at 24 weeks

bP<0.0001 vs placebo + 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.

 

SIGNIFICANT BLOOD PRESSURE REDUCTION1,2

Other end point: Significant mean changes from baseline in systolic BP with FARXIGA + metformin relative to placebo + metformin at 24 weeks1,2

Significant mean changes from baseline in systolic BP with FARXIGA + metformin relative to placebo + metformin at 24 weeks
Significant mean changes from baseline in systolic BP with FARXIGA + metformin relative to placebo + metformin at 24 weeks

cP<0.05 vs placebo + metformin.

BL=baseline.

Values are last observation (including data after rescue) carried forward.

FARXIGA is not indicated for the treatment of hypertension.

Blood pressure reduction was an other end point.

Hypotension: FARXIGA causes intravascular volume contraction, and symptomatic hypotension can occur. Assess and correct volume status before initiating FARXIGA in patients with impaired renal function, elderly patients, or patients on loop diuretics. Monitor for hypotension.

 

STUDY DESIGN1,2

FARXIGA as Add-On Therapy to Metformin

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

Randomization with FARXIGA 5 mg (n=137), FARXIGA 10 mg (n=135),  Dapagliflozin 2.5mg (n=137)  Placebo (n=137)

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 adult patients with type 2 diabetes who have inadequate glycemic control with metformin.

 

Study Length

24 weeks

 

 

Key Inclusion Criteria

Patients were 18 to 77 years of age with type 2 diabetes who had an A1C of ≥7.0% and ≤10.0%, BMI ≤45 kg/m2, fasting C-peptide ≥1.0 ng/mL, and were given a stable dose of metformin (≥1500 mg/day) for ≥8 weeks prior to enrollment. Patients with systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg were excluded.

 

 

Study Dosing

Patients on metformin at a dose of at least 1500 mg per day were randomized after completing a 2-week, single-blind, placebo lead-in period. Following the lead-in period, eligible patients were randomized to dapagliflozin 2.5 mg,§ FARXIGA 5 mg, FARXIGA 10 mg, or placebo in addition to their current dose of metformin.

§Dapagliflozin 2.5 mg is not an FDA-approved dose.

FARXIGA tablets shown are not actual sizes.

Primary End Point

Change in A1C from baseline at Week 24

Select Secondary End Point

  • Change in body weight from baseline at Week 24

Other End Point

  • Change in seated systolic blood pressure at Week 24