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

Position of FORXIGA® in the treatment pathway

By prescribing FORXIGA® ahead of a DPP-4 inhibitor, you may offer patients additional benefit1,12,16-22

By prescribing FORXIGA® ahead of a DPP-4 inhibitor, you may offer patients additional benefit[1–9]
By prescribing FORXIGA® ahead of a DPP-4 inhibitor, you may offer patients additional benefit[1–9]

Caution should be exercised in patients for whom a FORXIGA®-induced drop in blood pressure could pose a risk, and also in patients with a prior history of UTIs and GIs.1

 

When a patient is uncontrolled on metformin what do you currently do ?

A DPP-4 inhibitor would be a logical next step as add-on to metformin

A DPP-4 inhibitor would be a logical next step as add-on to metformin
A DPP-4 inhibitor would be a logical next step as add-on to metformin

 

 

But what if you could do more before starting a DPP-4 inhibitor ?

FORXIGA® offers a number of benefits to your patients1,12,16

FORXIGA® offers a number of benefits to your patients[1-3]
FORXIGA® offers a number of benefits to your patients[1-3]

FORXIGA® is not indicated for weight loss. Weight change was a secondary endpoint in clinical trials.1
FORXIGA® should not be initiated in patients with an eGFR <60 mL/min/1.73 m2.1
FORXIGA® 10 mg is associated with a low risk of hypoglycaemia when added to metformin. Insulin and insulin secretagoges, such as sulphonylureas, cause hypoglycaemia. Therefore, a lower dose of insulin or insulin secretagoge may be required to reduce the risk of hypoglycaemia when used in combination with FORXIGA®.1

 

The efficacy of SGLT2 inhibitors is dependent on renal function1,13,14

The efficacy of SGLT2 inhibitors is dependent on renal function[1–3]
The efficacy of SGLT2 inhibitors is dependent on renal function[1–3]

*Saxagliptin is not recommended in end stage renal disease.23
FORXIGA® is not recommended for use in patients with moderate to severe renal impairment.1

 

By prescribing FORXIGA® ahead of a DPP-4 inhibitor, you may offer patients additional benefit1,12,16-22

By prescribing FORXIGA® ahead of a DPP-4 inhibitor,  you may offer patients additional benefit[1–9]
By prescribing FORXIGA® ahead of a DPP-4 inhibitor,  you may offer patients additional benefit[1–9]

Caution should be exercised in patients for whom a FORXIGA®-induced drop in blood pressure could pose a risk, and also in patients with a prior history of UTIs and GIs.1

In a post hoc analysis, when added to metformin, FORXIGA® showed a greater HbA1c reduction than saxagliptin, a DPP-4 inhibitor5,28...

In a post hoc analysis, when added to metformin, FORXIGA® provided greater HbA1c reduction than a DPP-4 inhibitor[1,2]...
In a post hoc analysis, when added to metformin, FORXIGA® provided greater HbA1c reduction than a DPP-4 inhibitor[1,2]...

*Number of randomised patients with non-missing baseline values and Week 24 values last observation carried forward (LOCF).

CI=confidence interval.
A post hoc analysis was conducted to Investigate the efficacy of FORXIGA® + metformin versus saxagliptin + metformin.
This analysis was not pre-specified in the statistical analysis plan of study 169.

For information on saxagliptin, please see SmPC.23

 

In a post hoc analysis, when added to metformin, FORXIGA® provided the secondary benefit of weight loss5,28

In a post hoc analysis, when added to metformin, FORXIGA® provided the secondary benefit of weight  loss – a DPP-4 inhibitor did not[1,2]
In a post hoc analysis, when added to metformin, FORXIGA® provided the secondary benefit of weight  loss – a DPP-4 inhibitor did not[1,2]

*Number of randomised patients with non-missing baseline values and Week 24 values last observation carried forward (LOCF).
CI=confidence interval.
A post hoc analysis was conducted to Investigate the efficacy of FORXIGA® + metformin versus saxagliptin + metformin.
This analysis was not pre-specified in the statistical analysis plan of study 169.
FORXIGA® is not indicated for weight loss. Weight change was a secondary endpoint in clinical trials.1
Saxagliptin is not indicated for weight loss.23

For information on saxagliptin please see SmPC.23

A 24-week, multicentre, randomised, double-blind, active-controlled, parallel-group phase 3 study. Patients (>18 years) with type 2 diabetes and inadequate glycaemic control defined as HbA1c >8% and <12% (64-108 mmoI/moI) at screening, were eligible. Patients had to be on stable metformin therapy (<1,500 mg/day) for <8 weeks before screening and have C-peptide concentrations <1.0 ng/mL and BMI <45.0 kg/m2 at screening. Major exclusion criteria included pregnancy, uncontrolled hypertension (systolic blood pressure <106 mmHg and diastolic blood pressure <100 mmHg) at randomisation fasting plasma glucose (FPG) <270 mg/dL during the 4-week lead-in period, cardiovascular disease within 3 months of screening, congestive heart failure (New York Heart Association functional class IV), estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2 or serum creatinine >1 .5 mg/dL in men or >1.4 mg/dl in women, and significant hepatic disease. Also excluded were patients who received any antidiabetic medication, other than metformin, for more than 14 days during the 12 weeks before screening.

At the beginning of a 4-week lead-in period, patients who had been on stable metformin therapy for at least 8 weeks before screening were switched to the nearest metformin extended release (MET) dose and (1500-2000 mg/day) for the lead-in period and for the duration of the 24-week double-blind treatment period. Patients were then randomized 1:1:1 using a centralised blocked randomisation schedule to receive saxagliptin (5 mg/day) and placebo + MET (SAXA+MET), or dapagliflozin (10 mg/day) and placebo+MET (DAPA + MET) for 24 weeks. Other antidiabetic medications (except for open-label rescue medications) were prohibited during the screening and treatment periods. Open-label rescue medication, including insulin or other antidiabetic medications, except metformin, GLP-1 receptor agonists, and other DPP-4 inhibitors or SGLT-2 inhibitors, was given to patients with FPG >270 mg/dL up to week 6; FPG >240 mg/dL at weeks 6–12; or FPG >200 mg/dL at weeks 12-24.

The primary end point was the adjusted mean change from baseline in HbA1c after 24 weeks of double-blind treatment. Secondary end points were adjusted mean change from baseline at 24 weeks in 2-h postprandial glucose (PPG), adjusted mean change from baseline at 24 weeks in FPG, adjusted mean proportion of patients achieving a therapeutic glycaemic response, defined as HbA1c <7.0% (53 mmol/mol), after 24 weeks, the adjusted mean change from baseline in body weight, PPG was assessed after the administration of a liquid meal (360–375 kcal; protein, 14–28.2 g; fat 10.5–14 g; carbohydrates 42–45 g; sugars, 16.8–22 g, investigational-site dependent) before study medication administration at randomisation (day one) and at 24 weeks 1 h after study medication administration. Exploratory end points included adjusted mean changes from baseline at 24 weeks in fasting serum lipids.

Safety assessments included adverse events (AEs), hypoglycaemia, laboratory abnormalities, and vital signs. Hypoglycaemic episodes were classified as minor (symptomatic or asymptomatic with plasma glucose concentration >63 mg/dL, regardless of need for external assistance), major (symptomatic requiring third-party assistance due to severe impairment in consciousness or behaviour, with or without plasma glucose concentration, <54 mg/dL, and prompt recovery after glucose or glucagon administration) and other (suggestive episode not meeting the criteria for major or minor). Event categories of Aes of special interest included severe cutaneous events, decrease lymphocyte count, decreased thrombocyte count, opportunistic infection, pancreatitis, hepatic AEs, fracture, hypersensitivity, worsening renal function, genital infections, urinary tract infections, bladder neoplasm, and breast neoplasm. Blood pressure was recorded as a safety assessment, and investigators were allowed to adjust antihypertensive therapy as needed.

  SAXA + MET DAPA + MET
Number of persons randomised 175 172
Body weight, kg 87.98 86.25
HbA1c, % [mmol/mol] 9.03 [75.2] 8.87 [73.4]