FORXIGA® (dapagliflozin)

FORXIGA® is a highly selective SGLT2 inhibitor for type 2 diabetes mellitus, with 4-year safety and efficacy data, that removes glucose and its associated calories via the kidney.1

Efficacy

Significant, sustained HbA1c reductions as add-on to metformin, across the treatment pathway12,16,33-36

Achieve significant, sustained HbA1c reductions with FORXIGA® 10 mg added to metformin12,16

The primary endpoint showed that when added to metformin, FORXIGA® 10 mg demonstrated significant HbA1c reductions (-0.84%/ -9.0 mmol/mol) vs placebo (-0.30% / -3.0 mmol/mol) after 24 weeks (treatment difference: 0.54% (95% Cl -0.74, -0.34).12

For significant HbA1c reductions with FORXIGA® 10 mg added to metformin1,2
For significant HbA1c reductions with FORXIGA® 10 mg added to metformin1,2

*Data are mean change from baseline after adjustment for baseline value. Data after rescue are excluded.
Analyses were obtained by longitudinal repeated measures analyses.16

Achieve significant HbA1c reductions in patients with high baselines with FORXIGA® 10 mg to metformin12

Patients with HbA1c baselines ≥9% achieved 1.32% reduction in HbA1c with FORXIGA® 10 mg at 24 weeks (in a subgroup analysis)12

For significant HbA1c reductions in patients with high baselines, add FORXIGA® 10 mg to metformin[2,6]
For significant HbA1c reductions in patients with high baselines, add FORXIGA® 10 mg to metformin[2,6]

*Changes reported for week 24 are adjusted for baseline values and are based on last observation carried forward (LOCF). The primary efficacy dataset consisted of all randomised patients who received at least one dose of double-blind study medication and who had both a baseline and at least one post-baseline measurement. Mean baseline HbA1c levels for placebo arm were 8.11% (65 mmol/mol) and FORXIGA® arm were 7.92% (63 mmol/mol).12

Achieve significant HbA1c reductions with FORXIGA® as add-on therapy to metformin plus sulphonylurea33

FORXIGA® resulted in significant HbA1c reductions compared with placebo when used in combination with metformin + sulphonylurea, with a significantly higher proportion of patients with HbA1c <7% at week 24 (31.8% vs. 11.1% respectively; P<0.0001).33

FORXIGA® reduces HbA(1c) as add-on therapy to metformin plus sulphonylurea[1]
FORXIGA® reduces HbA(1c) as add-on therapy to metformin plus sulphonylurea[1]

 

*A 24-week randomised, double-blind, parallel-group phase 3 study, with an on-going 28 week blinded extension period, to evaluate the safety and efficacy of FORXIGA® in combination with metformin + sulphonylurea compared with placebo. Patients enrolled in the study were aged ≥18 years with HbA1c 7.0–10.5% with type 2 diabetes inadequately controlled on metformin + sulphonylurea. FORXIGA® was given as 10 mg alongside metformin at ≥ 1500 mg/d and a maximum tolerated dose of sulphonylurea. Metformin could not be down-titrated and sulphonylurea could only be down-titrated once to reduce hypoglycaemic events.33

  • The primary endpoint of the study was mean change in HbA1c from baseline to week 24. Secondary endpoints included mean change in fasting blood plasma glucose, mean change in body weight and proportion of patients achieving HbA1c <7.0% at week 24.33

Achieve HbA1c reductions with FORXIGA® as part of triple therapy34

When given as part of triple therapy, FORXIGA® reduces HbA1c.34

In four individual studies, HbA1c reductions at 24 weeks were -1.7% to -2.2% greater with FORXIGA® than placebo, with the greatest reduction seen when FORXIGA® was added to insulin + metformin.34

48 week data for FORXIGA® + sitagliptin + metformin suggest a HbA1c reduction is maintained.34

HbA1c reductions with FORXIGA®
HbA1c reductions with FORXIGA®

a Pre-specified or post-hoc analyses were performed on data from four previously published, 24-week studies in patients with type 2 diabetes to evaluate the efficacy of FORXIGA® as part of a triple combination therapy regimen. FORXIGA® was administered to patients with type 2 diabetes inadequately controlled on two existing antidiabetic medications.34

  • Sulphonylurea + metformin (study A)
  • Sulphonylurea + metformin (study B)
  • Insulin + metformin.

Achieve significant HbA1c reduction with FORXIGA® 10 mg added to insulin35,36

At the primary endpoint of 24 weeks, FORXIGA® + insulin resulted in significant HbA1c reductions compared with placebo + insulin (0.96% vs. 0.39%, mean difference 0.57% [CI 0.42% to 0.72%]).35

Additionally, in patients whose type 2 diabetes was inadequately controlled on insulin, FORXIGA® improved glycaemic control and stabilised insulin dosing without increasing major hypoglycaemic episodes, over a period of 104 weeks.36

For significant reductions in HbA(1c) add FORXIGA® 10 mg to insulin[1,2]
For significant reductions in HbA(1c) add FORXIGA® 10 mg to insulin[1,2]

 

*Data at 104 weeks are adjusted mean change from baseline with 95% CI estimated from a mixed model. Analyses use the full analysis set and include data after insulin up-titration.36

Mean HbA1c at baseline was 8.6% (70 mmol/mol) for the FORXIGA® arm and 8.5% (69 mmol/mol) for the placebo arm.35

 

Insulin sparing with FORXIGA®

At 24 weeks, change in total daily insulin dose (units) from baseline was 8% in the placebo + insulin group and -1.5% in the FORXIGA® + insulin group.35

The probability of insulin up-titration or study discontinuation because of poor glycaemic control was consistently higher in the placebo + insulin arm, compared to the FORXIGA® + insulin arm over 104 weeks.36

Insulin sparing with FORXIGA®
Insulin sparing with FORXIGA®

*Data at 104 weeks are adjusted mean change from baseline with 95% CI estimated from a mixed model. Analyses use the full analysis set and include data after insulin uptitration.36

Mean HbA1c at baseline was 8.6% (70 mmol/mol) for the FORXIGA® arm and 8.5% (69 mmol/mol) for the placebo arm.35

 

Achieve glycaemic control and delay the time to insulin up-titration or discontinuation with FORXIGA® 10 mg35

The adjusted proportion of patients in which insulin up-titration or discontinuation occured was lower in the FORXIGA® group (15.3%), compared to placebo (42.8%).36

For glycaemic control and delay the time to insulin up-titration or discontinuation with FORXIGA<sup>®</sup> 10 mg
For glycaemic control and delay the time to insulin up-titration or discontinuation with FORXIGA<sup>®</sup> 10 mg

*Symbols represent censored observations.
"Week" is the actual number of days from the first dose of double-blind study medication divided by 7, not the scheduled visit week.
Values for patients at risk are for the beginning of the period.