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) proven clinical trial data

Significant results demonstrated across 7 randomised controlled trials3,6-10 up to 4 years in duration11

What does weight loss with FORXIGA® (dapagliflozin) look like for your patients?

In patients taking FORXIGA®(dapagliflozin), absolute weight loss was shown to increase in proportion to BMI, across 10 clinical trials4*†‡

*FORXIGA® (dapagliflozin) is not indicated for weight loss. Weight change was a secondary endpoint in clinical trials.1

Change from baseline in body weight over time by BMI class4

 Change from baseline in body weight over time by BMI class (FORXIGA® vs placebo)
 Change from baseline in body weight over time by BMI class (FORXIGA® vs placebo)

Adapted from Shatskov A et al 2016

(P<0.0001)

BMI, body mass index.

There was a significant treatment-by-BMI subgroup interaction (P<0.0001) with body weight, suggesting a difference in treatment effect based on BMI. Absolute weight loss increased with baseline BMI and was greatest in patients with BMI ≥40 kg/m2 who received dapagliflozin 10 mg; across all baseline BMI categories patients generally lost 1%–2% of their baseline weight with dapagliflozin 5 mg and 2%–3% with dapagliflozin 10 mg. Similar proportions of patients across BMI subgroups achieved weight reductions of ≥5% with dapagliflozin 5 mg (9.7%–20.9%) and 10 mg (16.7%–24.4%); placebo (4.2%–6.7%). After 24 weeks of treatment with dapagliflozin 5 or 10 mg, 18%–29% of obese patients shifted 1 BMI category lower compared with 9%–13% of patients who received placebo.4

*FORXIGA® (dapagliflozin) is not indicated for weight loss. Weight change was a secondary endpoint in clinical trials.1

Change from baseline in body weight over time by BMI class 4

Change from baseline in body weight over time by BMI class (FORXIGA® vs placebo)
Change from baseline in body weight over time by BMI class (FORXIGA® vs placebo)

Adapted from Shatskov A et al 2016

(P<0.0001)
BMI, body mass index.
There was a significant treatment-by-BMI subgroup interaction (P<0.0001) with body weight, suggesting a difference in treatment effect based on BMI. Absolute weight loss increased with baseline BMI and was greatest in patients with BMI ≥40 kg/m2 who received dapagliflozin 10 mg; across all baseline BMI categories patients generally lost 1%–2% of their baseline weight with dapagliflozin 5 mg and 2%–3% with dapagliflozin 10 mg. Similar proportions of patients across BMI subgroups achieved weight reductions of ≥5% with dapagliflozin 5 mg (9.7%–20.9%) and 10 mg (16.7%–24.4%); placebo (4.2%–6.7%). After 24 weeks of treatment with dapagliflozin 5 or 10 mg, 18%–29% of obese patients shifted 1 BMI category lower compared with 9%–13% of patients who received placebo.4

*FORXIGA® (dapagliflozin) is not indicated for weight loss. Weight change was a secondary endpoint in clinical trials.1

Change from baseline in body weight over time by BMI class4

Change from baseline in body weight over time by BMI class (FORXIGA® vs placebo)
Change from baseline in body weight over time by BMI class (FORXIGA® vs placebo)

Adapted from Shatskov A et al 2016

(P<0.0001)
BMI, body mass index.
There was a significant treatment-by-BMI subgroup interaction (P<0.0001) with body weight, suggesting a difference in treatment effect based on BMI. Absolute weight loss increased with baseline BMI and was greatest in patients with BMI ≥40 kg/m2 who received dapagliflozin 10 mg; across all baseline BMI categories patients generally lost 1%–2% of their baseline weight with dapagliflozin 5 mg and 2%–3% with dapagliflozin 10 mg. Similar proportions of patients across BMI subgroups achieved weight reductions of ≥5% with dapagliflozin 5 mg (9.7%–20.9%) and 10 mg (16.7%–24.4%); placebo (4.2%–6.7%). After 24 weeks of treatment with dapagliflozin 5 or 10 mg, 18%–29% of obese patients shifted 1 BMI category lower compared with 9%–13% of patients who received placebo.4

*FORXIGA® (dapagliflozin) is not indicated for weight loss. Weight change was a secondary endpoint in clinical trials.1

Change from baseline in body weight over time by BMI class4

Change from baseline in body weight over time by BMI class (FORXIGA® vs placebo)
Change from baseline in body weight over time by BMI class (FORXIGA® vs placebo)

Adapted from Shatskov A et al 2016

(P<0.0001)
BMI, body mass index.
There was a significant treatment-by-BMI subgroup interaction (P<0.0001) with body weight, suggesting a difference in treatment effect based on BMI. Absolute weight loss increased with baseline BMI and was greatest in patients with BMI ≥40 kg/m2 who received dapagliflozin 10 mg; across all baseline BMI categories patients generally lost 1%–2% of their baseline weight with dapagliflozin 5 mg and 2%–3% with dapagliflozin 10 mg. Similar proportions of patients across BMI subgroups achieved weight reductions of ≥5% with dapagliflozin 5 mg (9.7%–20.9%) and 10 mg (16.7%–24.4%); placebo (4.2%–6.7%). After 24 weeks of treatment with dapagliflozin 5 or 10 mg, 18%–29% of obese patients shifted 1 BMI category lower compared with 9%–13% of patients who received placebo.4

*FORXIGA® (dapagliflozin) is not indicated for weight loss. Weight change was a secondary endpoint in clinical trials.1

Change from baseline in body weight over time by BMI class4

Change from baseline in body weight over time by BMI class (FORXIGA® vs placebo)
Change from baseline in body weight over time by BMI class (FORXIGA® vs placebo)

Adapted from Shatskov A et al 2016

(P<0.0001)
BMI, body mass index.
There was a significant treatment-by-BMI subgroup interaction (P<0.0001) with body weight, suggesting a difference in treatment effect based on BMI. Absolute weight loss increased with baseline BMI and was greatest in patients with BMI ≥40 kg/m2 who received dapagliflozin 10 mg; across all baseline BMI categories patients generally lost 1%–2% of their baseline weight with dapagliflozin 5 mg and 2%–3% with dapagliflozin 10 mg. Similar proportions of patients across BMI subgroups achieved weight reductions of ≥5% with dapagliflozin 5 mg (9.7%–20.9%) and 10 mg (16.7%–24.4%); placebo (4.2%–6.7%). After 24 weeks of treatment with dapagliflozin 5 or 10 mg, 18%–29% of obese patients shifted 1 BMI category lower compared with 9%–13% of patients who received placebo.4

This study was a post-hoc analysis of data pooled from 10 FORXIGA® (dapagliflozin) phase III,randomised double-blind, placebo-controlled, 24-week studies in adults (≥18 years of age) with type 2 diabetes (T2D) and body mass index (BMI) ≤45 kg/m2. The study aimed to assess the efficacy and safety of FORXIGA® (dapagliflozin) 5 and 10 mg once daily in subgroups of patients with T2D stratified by BMI category.

FORXIGA® (dapagliflozin) 5 or 10 mg or placebo were administered as: 

  •   Monotherapy in treatment-naive patients (NCT00528372)
  •   Initial combination therapy with metformin (NCT00859898)

Add-on to the following:

  • Metformin (NCT00855166, NCT00528879)    
  • Glimepiride (NCT00680745)
  • Pioglitazone(NCT00683878)
  • Sitagliptin ± metformin (NCT00984867)       
  • Insulin ± up to 2 other anti-diabetic medications (NCT00673231)
  • Usual care in patients with CVD (NCT01042977)
  • Usual care in patients with CVD and hypertension (NCT01031680)

Changes from baseline to week 24 in HbA1c, body weight, and systolic blood pressure were analysed in patients stratified by BMI (kg/m2) categories:

  • Normal weight: 18.5 ≥ 25 kg/m2
  • Overweight: 25 ≥ 30 kg/m2
  • Obese Class I: 30 ≥ 35 kg/m2
  • Obese Class II: 35 ≥ 40 kg/m2
  • Obese Class III: ≥ 40 kg/m2

Longitudinal repeated measures analyses were performed using a model that included baseline, treatment, subgroup, week, and the following interaction terms: week-by-treatment, week-by-baseline, treatment-by-subgroup, study-by-baseline, and week-by-treatment-by-subgroup.

Adverse events were recorded during the 24-week study period for each trial in the pooled data set.

*The use of FORXIGA® (dapagliflozin) with pioglitazone is not recommended.1