FORXIGA® (dapagliflozin)

FORXIGA® (dapagliflozin) 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

FORXIGA®(dapagliflozin) in secondary care

Start change earlier for your patients

Consider FORXIGA® (dapagliflozin) ahead of a GLP-1 for:

  • A numerically similar reduction in HbA1c to once-weekly exenatide, a GLP-1 (in an RCT)10
  • The secondary benefit of weight loss, proportional to patient BMI1,4
  • Simple dosing1

RCT randomised controlled trial.

What could FORXIGA® (dapagliflozin) do for your patients ahead of a GLP-1 and across the treatment pathway?

DURATION-8 was a 28 week, multicentre, double-blind, randomised, active-controlled phase 3 trial at 109 sites in six countries, and a subsequent ongoing 52-week extension. Adults (aged ≥18 years) with type 2 diabetes and inadequate glycaemic control (HbA1c 8–12% [64–108 mmol/mol]) despite stable metformin monotherapy (≥1500 mg/day) were randomly assigned 1:1:1.  695 patients were randomly assigned to receive once-weekly exenatide 2 mg by subcutaneous injection plus once-daily FORXIGA® (dapagliflozin) 10 mg oral tablets (n=231), exenatide with FORXIGA® (dapagliflozin)-matched oral placebo (n=231; n=1 untreated), or FORXIGA® (dapagliflozin) with exenatide matched placebo injections (n=233). Randomisation was stratified by baseline HbA1c (<9.0% vs ≥9.0% [<75 mmol/mol vs ≥75 mmol/mol]). The intention-to-treat population comprised 685 participants (mean HbA1c 9.3% [SD 1.1]; 78 mmol/mol), of whom 611 (88%) completed the study.

The primary endpoint was change in HbA1c from baseline to week 28. Secondary endpoints were the change from baseline in fasting plasma glucose at week 2 and week 28, and 2 h postprandial glucose at week 28; the proportion of patients with an HbA1c less than 7.0% (<53 mmol/mol) at week 28; change in weight at week 28; the proportion of patients with weight loss of 5% or more at week 28; and change in systolic blood pressure at week 28. Analyses were by intention-to-treat.

Safety assessments included adverse events, laboratory abnormalities, vital signs, and hypoglycaemic events. Outcomes for the 52-week extension now published.14

 

This was a 24-week, randomised, placebo-controlled, double-blinded, multicentre trial followed by two site and patient-blinded extension periods of 24 and 56 weeks, respectively. The study aimed to evaluate the efficacy and safety of FORXIGA® (dapagliflozin) 10 mg + insulin after a total of 104 weeks.

A total of 808 patients were recruited from 126 centres, whose T2DM was  inadequately controlled on insulin ≥30 IU/day (HbA1c 7.5-10.5%) for at least 8 weeks with or without up to two oral antidiabetic drugs. Patients were initially randomized on a 1:1:1:1 basis to placebo or FORXIGA® (dapagliflozin) 2.5, 5 or 10 mg once daily, in addition to open-label therapy with their usual daily insulin dose and existing oral antidiabetic drugs. Following completion of 48 weeks of treatment, patients receiving FORXIGA® (dapagliflozin) 5 mg were switched to the 10 mg dose for the remainder of the study. Throughout the study, insulin dose was held within 10% of the baseline level unless insulin up-titration was clinically indicated.

The primary efficacy variable was change in HbA1c from baseline to week 24. Key secondary efficacy variables at 24 weeks included change in total body weight from baseline, change in calculated mean daily insulin dose, proportion of patients with calculated mean daily insulin dose reduction ≥10% from baseline and change in fasting plasma glucose from baseline. At 104 weeks, it was assessed whether the effects on HbA1c, fasting plasma glucose, insulin dose, body weight and urinary glucose excretion were maintained.

Safety evaluations over the 104-week period included adverse events, laboratoryvariables, and vital signs.