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In a pool of 12 placebo-controlled studies, the most common adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%).
FARXIGA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Please read US Full Prescribing Information and Medication Guide for FARXIGA.
You may report side effects related to AstraZeneca products by clicking here.
AN SGLT2 INHIBITOR TREATMENT FOR ADULTS WITH TYPE 2 DIABETES MELLITUS
FARXIGA as Add-On to Insulin ± Oral Antidiabetic(s)
Primary end point: FARXIGA achieved significant reduction in A1C levels when added to insulin ± up to 2 oral antidiabetic agents (OADs) at 24 weeks1,2
aP<0.0001 vs placebo + insulin.‡
BL=baseline; OAD=oral antidiabetic.
Values are last observation (prior to rescue for rescued patients) carried forward and represent adjusted mean change from baseline.
Rates of hypoglycemia
‡Up to 2 OADs.
§Severe episodes of hypoglycemia were defined as episodes of severe impairment in consciousness or behavior, requiring external (third party) assistance, and with prompt recovery after intervention regardless of glucose level.
Hypoglycemia: FARXIGA can increase the risk of hypoglycemia when coadministered with insulin and insulin secretagogues. Consider lowering the dose of these agents when coadministered with FARXIGA.
A secondary end point: Significant weight reduction with FARXIGA when added to insulin ± up to 2 OADs at 24 weeks1,2
bP<0.0001 + insulin ± up to 2 OADs.
BL=baseline; OAD=oral antidiabetic.
ౠup to 2 OADs.
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.
-5.7 IU/DAY PLACEBO-ADJUSTED REDUCTION IN REQUIRED MEAN DOSE OF INSULIN WITH FARXIGA 5 MG‡ AT WEEK 24 (P<0.0001; BASELINE DOSES WERE 77.0 IU AND 73.7 IU FOR FARXIGA 5 MG AND PLACEBO, RESPECTIVELY)1,2
-6.2 IU/DAY PLACEBO-ADJUSTED REDUCTION IN REQUIRED MEAN DOSE OF INSULIN WITH FARXIGA 10 MG‡ AT WEEK 24 (P<0.0001; BASELINE DOSES WERE 78.0 IU AND 73.7 IU FOR FARXIGA 10 MG AND PLACEBO, RESPECTIVELY)1,2
ౠup to 2 OADs.
A secondary end point: Mean daily insulin dose reductions at 24 weeks1
FARXIGA 10 mg + insulin ± ≤2 OADs |
Placebo + insulin ± ≤2 OADs |
|---|---|
| 19.6%c | 11.0% |
cP<0.05 vs placebo.
Values are last observation (after rescue) carried forward.
†Insulin dose reduction was a secondary end point.
FARXIGA as Add-On to Insulin ± Oral Antidiabetic(s)
24-week, randomized, double-blind, placebo-controlled, parallel-group, international, multicenter trial
¶Dapagliflozin 2.5 mg is not an FDA-approved dose; thus, data from this treatment group are not presented.
Evaluate the efficacy and safety of FARXIGA in adult patients with type 2 diabetes inadequately controlled with insulin and up to 2 oral antidiabetic agents (OADs).
24 weeks
Men and women 18 to 80 years of age were enrolled if they had type 2 diabetes mellitus, inadequate glycemic control (A1C ≥7.5% and ≤10.5%), and a BMI of 45 kg/m2 or less. Participants had to have received a stable insulin regimen with a mean daily insulin dose of 30 IU or more for at least 8 weeks, with daily insulin requirements varying by more than 10% on no more than one occasion in the 7 days before randomization. Additional treatment with stable doses of up to 2 OADs was allowed. Patients were stratified into 2 strata (with and without OADs).
Patients were randomized 1:1:1:1 to dapagliflozin 2.5 mg,# FARXIGA 5 mg, FARXIGA 10 mg, or placebo once daily in addition to open-label therapy with their usual daily dose of insulin and existing OADs. Mean dose of insulin was ≥30 IU of injectable insulin per day, in addition to current regimen of up to 2 OADs (if applicable).
#Dapagliflozin 2.5 mg is not an FDA-approved dose.
FARXIGA tablets shown are not actual sizes.
Change in A1C from baseline at Week 24
In a pool of 12 placebo-controlled studies, the most common adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%).
FARXIGA is indicated:
FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Please read US Full Prescribing Information and Medication Guide for FARXIGA.
You may report side effects related to AstraZeneca products by clicking here.
FARXIGA is indicated:
FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
References:
Reference:
Most common (≥5%) and occurring more frequently than comparator in clinical trials: nausea (16.9%), diarrhea (12.7%), headache (8.0%), vomiting (6.8%), constipation (5.9%), injection-site pruritus (5.9%), injection-site nodule (5.3%), and dyspepsia (5.1%)
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus
BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Please read US Full Prescribing Information and Medication Guide for BYDUREON, including Boxed WARNING.
References:
FARXIGA is indicated:
