PROVEN IN PATIENTS WITH T2D
FARXIGA is proven to reduce A1C, with the additional benefit of weight and SBP reduction
FARXIGA has been studied as initial monotherapy, in initial combination therapy with metformin XR, as add-on therapy, and in combination with other agents.
FARXIGA is not indicated for weight loss or the treatment of hypertension.
IN PATIENTS WITH T2D
Proven A1C reductions, plus weight reduction and SBP benefits
Across clinical trials, FARXIGA, as initial combination therapy or as add-on, demonstrated significant reductions in glucose and body weight1-5
The recommended starting dose of FARXIGA is 5 mg once daily.
FARXIGA and exenatide are not indicated for weight loss.
*The median metformin XR dose was 2000 mg per day.
†Exenatide extended-release injectable suspension.
‡Secondary end point: Mean weight reduction at 24 weeks.
§Secondary end point: Mean weight reduction at 28 weeks.
Values are last observation (prior to rescue for rescued patients) carried forward and represent adjusted mean change from BL.
In a separate study, FARXIGA provided additional benefit of SBP reduction as an add-on to metformin at 1 year (exploratory end point)1,6
FARXIGA 5 mg + metformin relative to glipizide + metformin
PRIMARY END POINT: 0.5% mean reduction in A1C from BL (n=400; BL=7.7%) with FARXIGA + metformin was noninferior to glipizide + metformin at 52 weeks (0.5%; n=401; BL=7.7%).1,6,¶
FARXIGA is not indicated for the treatment of hypertension.
‖P<0.0001 vs glipizide + metformin.
¶Patients on metformin ≥1500 mg per day were randomized following a 2-week placebo lead-in period to glipizide 5 mg or dapagliflozin 2.5 mg and were uptitrated over 18 weeks to optimal glycemic effect (FPG <110 mg/dL, <6.1 mmol/L) or to the highest dose level (up to glipizide 20 mg and FARXIGA 10 mg) as tolerated by patients. At the end of the titration period, 87% of patients treated with FARXIGA had been titrated to the maximum study dose (10 mg) vs 73% treated with glipizide (20 mg). Dapagliflozin 2.5 mg is not an FDA-approved dose. Values are last observation carried forward.
FARXIGA: Additional Glycemic Control Studies
FARXIGA can be used to start treatment as monotherapy or in combination with metformin.
FARXIGA is also complementary to other antidiabetic agents. It has been studied as an add-on or in combination with:
- Sitagliptin, a dipeptidyl peptidase-4 inhibitor
- Glimepiride, a sulfonylurea
- Pioglitazone, a thiazolidinedione
- Exenatide, a glucagon-like peptide-1 receptor agonist
FARXIGA has a proven safety profile
Pooled safety data across 12 placebo-controlled clinical studies of glycemic control in patients with T2D1
Adverse reactions reported in ≥2% of patients treated with FARXIGA
- Additional common AEs seen in >2% of patients taking FARXIGA included back pain, dyslipidemia, nasopharyngitis, nausea, and influenza1
*n for females: FARXIGA 5 mg=581, FARXIGA 10 mg=598, placebo=677; n for males: FARXIGA 5 mg=564, FARXIGA 10 mg=595, placebo=716.
AE=adverse event; BL=baseline; CKD=chronic kidney disease; CV=cardiovascular; eCVD=established cardiovascular disease; FDA=US Food and Drug Administration; FPG=fasting plasma glucose; HFrEF=heart failure with reduced ejection fraction; SBP=systolic blood pressure; T2D=type 2 diabetes.
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