In adults with Type 1 diabetes (T1D), as an adjunct to insulin,

THE DEPICT PROGRAMME IS THE FIRST* PHASE III TRIAL TO BE REPORTED USING A SELECTIVE SGLT-2i1

*In the EU.

DEPICT-1 study design
DEPICT-1 study design

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Forxiga 10 mg is not licensed in the EU for the treatment of T1D.
**Forxiga 5 mg is only indicated in adult T1D patients with a BMI of ≥27 kg/m2.4
BMI, body mass index; C-peptide, connecting peptide; CGM, continuous glucose monitor; CrCl,
creatinine clearance; HbA1c, haemoglobin A1c; IU, international units; T1D, Type 1 diabetes.

In adults with T1D, as an adjunct to insulin

FORXIGA 5 mg DELIVERED CLINICALLY RELEVANT HbA1c REDUCTIONS

FORXIGA 5mg DELIVERED CLINICALLY RELEVANT HbA1c REDUCTIONS
FORXIGA 5mg DELIVERED CLINICALLY RELEVANT HbA1c REDUCTIONS

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Forxiga 5 mg + insulin: (n=259) mean baseline HbA1c was 8.52%; mean baseline total daily insulin dose was 62.91 IU. Placebo + insulin: (n=260) mean baseline HbA1c was 8.50%; mean baseline total daily insulin dose was 61.74 IU.

†The information presented here is from DEPICT-1. Efficacy was also demonstrated in DEPICT-2, which showed HbA1c reductions of -0.37% (P<0.0001).4 CI, confidence interval; HbA1c, haemoglobin A1c; IU, international units.

Patients saw significant HbA1c reductions as early as week 4, with results sustained throughout the 24-week trial1,4

FORXIGA 5mg DELIVERED CLINICALLY RELEVANT HbA<sub>1c</sub>REDUCTIONS
FORXIGA 5mg DELIVERED CLINICALLY RELEVANT HbA<sub>1c</sub>REDUCTIONS

In adults with T1D, as an adjunct to insulin

TWICE AS MANY PATIENTS ACHIEVED ≥0.5% HbA1c REDUCTION WITHOUT SEVERE HYPOGLYCAEMIA WITH FORXIGA 5 mg VS PLACEBO AT 24 WEEKS1,4‡§

TWICE AS MANY PATIENTS ACHIEVED -0.5% HbA1c REDUCTION WITHOUT SEVERE HYPOGLYCAEMIA WITH FORXIGA VS PLACEBO + INSULIN AT 24 WEEKS*
TWICE AS MANY PATIENTS ACHIEVED -0.5% HbA1c REDUCTION WITHOUT SEVERE HYPOGLYCAEMIA WITH FORXIGA VS PLACEBO + INSULIN AT 24 WEEKS*

‡The information presented here is from DEPICT-1. DEPICT-2 also demonstrated a higher proportion of Forxiga patients achieving this outcome: 39.5% in the Forxiga 5 mg arm and 20.1% in the placebo arm (odds ratio 2.71; 95% Cl, 1.81, 4.06).1,3
§Severe hypoglycaemia required assistance of another person to raise glucose levels and promote neurological recovery.5
CI, confidence intervals; HbA1c, haemoglobin A1c

PATIENTS SPEND MORE THAN HALF THEIR DAY WITHIN TARGET GLUCOSE RANGE WITH FORXIGA 5mg6 In adults with T1D, as an adjunct to insulin FORXIGA 5mg OFFERS PATIENTS THE ADDITIONAL BENEFIT OF WEIGHT REDUCTIONS Patients saw significant HbA1c reductions as early as week 4, with results lasting through the duration of the 24-week trial *The information presented here is from DEPICT-1. Efficacy was also demonstrated in DEPICT-2, which showed HbA1c reductions of -0.37%; P<0.0001.4 • FORXIGA extended the time a patient spent in glycaemic range by over 2 hours per day. • FORXIGA 5mg led to relative increases in mean CGM values in the target glucose range of 20% • The information presented here is from DEPICT-1, DEPICT-2 showed reductions of 2.5kg with Forxiga 5mg p<0.0001 vs placebo1 • Body weight reductions mostly occurred within the first 8 weeks and continued thereafter, reaching almost 3kg by Week 24 (P<0.0001)1 FORXIGA is not indicated for the management of weight loss. Weight change was a secondary end point in clinical trials. Adjusted mean change in HbA1c (%) 0.4 0.2 -0.2 -0.4 -0.6 -0.8 -1.0 0 Patients per timepoint Study week FORXIGA 5mg Placebo 254 257 252 256 246 248 238 237 233 233 230 227 2 4 6 8 10 12 14 16 18 20 22 24 0 In adults with T1D, as an adjunct to insulin, FORXIGA 5 MG DELIVERED CLINICALLY RELEVANT HbA1c REDUCTIONS FORXIGA 5mg + insulin (n=259): mean baseline HbA1c was 8. 52%; mean baseline total daily insulin dose was 62.91 IU1,2 Placebo + insulin (n=260): mean baseline HbA1c was 8.50%; mean baseline total daily insulin dose was 61.74 IU1,2 Mean change in HbA1c over 24 weeks 1,2* FORXIGA 5 mg is only indicated in adult type 1 diabetes patients with a BMI of ≥27 kg/m2.1 * The information presented here is from DEPICT-1. Efficacy was also demonstrated in DEPICT-2, which showed HbA1c reductions of -0.37%; P<0.0001.1 BMI=body mass index; T1D=type 1 diabetes. References: 1. FORXIGA. Summary of Product Characteristics. 2019. AstraZeneca UK Ltd. 2. Dandona P, Mathieu C, Phillip M, et al; on behalf of the DEPICT-1 Investigators. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, doubleblind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2017;5:864-876. -0.42 (difference from placebo) (-0.56 to -0.28) P<0.0001 0 40 60 20 Study treatment Patients with a ≥0.5% reduction in HbA1c without severe hypoglycaemia (%) Dapagliflozin 5mg vs placebo: odds ratio 3.09 (95% CI: 2.10 to 4.56)1,4 Dapagliflozin 5mg + insulin (n=259) 50% Placebo + insulin (n=260) 25% A higher proportion of patients were able to achieve an HbA1c reduction of -0.5% or more without severe hypoglycaemia1,2*† In adults with T1D, as an adjunct to insulin, MORE PATIENTS ACHIEVED CLINICALLY RELEVANT HbA1c REDUCTIONS WITHOUT SEVERE HYPOGLYCAEMIA OVER 24 WEEKS Twice as many patients achieved reductions without severe hypoglycaemia with FORXIGA vs placebo. FORXIGA 5 mg is only indicated in adult type 1 diabetes patients with a BMI of ≥27 kg/m2.1 * The information presented here is from DEPICT-1. DEPICT-2 also demonstrated a higher proportion of FORXIGA patients achieving this outcome: 39.5% in the 5-mg arm and 20.1% in the placebo arm; odds ratio 2.71 (95% Cl: 1.81 to 4.06).2,3 †Severe hypoglycaemia required assistance of another person to raise glucose levels and promote neurological recovery.4 BMI=body mass index; T1D=type 1 diabetes. References: 1. FORXIGA. Summary of Product Characteristics. 2019. AstraZeneca UK Ltd. 2. Dandona P, Mathieu C, Phillip M, et al; on behalf of the DEPICT-1 Investigators. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2017;5:864-876. 3. Mathieu C, Dandona P, Gillard P, et al; on behalf of DEPICT-2 Investigators. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT-2 Study): 24-week results from a randomized controlled trial. Diabetes Care. 2018. doi:10.2337/dc18-0623. 4. Danne T, Nimri R, Battelino T, et al. International consensus on use of continuous glucose monitoring. Diabetes Care. 2017;40(12):1631–1640. 10 h 26 min 12 h 24 min 12 h 30 min 10 h 20 min 1 h 10 min 24 h 12 h 18 h 6 h 24 h 12 h 18 h 6 h 1 h 7 min ≤70mg/dL >180mg/dL >70 to ≤180mg/dL In adults with T1D, as an adjunct
PATIENTS SPEND MORE THAN HALF THEIR DAY WITHIN TARGET GLUCOSE RANGE WITH FORXIGA 5mg6 In adults with T1D, as an adjunct to insulin FORXIGA 5mg OFFERS PATIENTS THE ADDITIONAL BENEFIT OF WEIGHT REDUCTIONS Patients saw significant HbA1c reductions as early as week 4, with results lasting through the duration of the 24-week trial *The information presented here is from DEPICT-1. Efficacy was also demonstrated in DEPICT-2, which showed HbA1c reductions of -0.37%; P<0.0001.4 • FORXIGA extended the time a patient spent in glycaemic range by over 2 hours per day. • FORXIGA 5mg led to relative increases in mean CGM values in the target glucose range of 20% • The information presented here is from DEPICT-1, DEPICT-2 showed reductions of 2.5kg with Forxiga 5mg p<0.0001 vs placebo1 • Body weight reductions mostly occurred within the first 8 weeks and continued thereafter, reaching almost 3kg by Week 24 (P<0.0001)1 FORXIGA is not indicated for the management of weight loss. Weight change was a secondary end point in clinical trials. Adjusted mean change in HbA1c (%) 0.4 0.2 -0.2 -0.4 -0.6 -0.8 -1.0 0 Patients per timepoint Study week FORXIGA 5mg Placebo 254 257 252 256 246 248 238 237 233 233 230 227 2 4 6 8 10 12 14 16 18 20 22 24 0 In adults with T1D, as an adjunct to insulin, FORXIGA 5 MG DELIVERED CLINICALLY RELEVANT HbA1c REDUCTIONS FORXIGA 5mg + insulin (n=259): mean baseline HbA1c was 8. 52%; mean baseline total daily insulin dose was 62.91 IU1,2 Placebo + insulin (n=260): mean baseline HbA1c was 8.50%; mean baseline total daily insulin dose was 61.74 IU1,2 Mean change in HbA1c over 24 weeks 1,2* FORXIGA 5 mg is only indicated in adult type 1 diabetes patients with a BMI of ≥27 kg/m2.1 * The information presented here is from DEPICT-1. Efficacy was also demonstrated in DEPICT-2, which showed HbA1c reductions of -0.37%; P<0.0001.1 BMI=body mass index; T1D=type 1 diabetes. References: 1. FORXIGA. Summary of Product Characteristics. 2019. AstraZeneca UK Ltd. 2. Dandona P, Mathieu C, Phillip M, et al; on behalf of the DEPICT-1 Investigators. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, doubleblind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2017;5:864-876. -0.42 (difference from placebo) (-0.56 to -0.28) P<0.0001 0 40 60 20 Study treatment Patients with a ≥0.5% reduction in HbA1c without severe hypoglycaemia (%) Dapagliflozin 5mg vs placebo: odds ratio 3.09 (95% CI: 2.10 to 4.56)1,4 Dapagliflozin 5mg + insulin (n=259) 50% Placebo + insulin (n=260) 25% A higher proportion of patients were able to achieve an HbA1c reduction of -0.5% or more without severe hypoglycaemia1,2*† In adults with T1D, as an adjunct to insulin, MORE PATIENTS ACHIEVED CLINICALLY RELEVANT HbA1c REDUCTIONS WITHOUT SEVERE HYPOGLYCAEMIA OVER 24 WEEKS Twice as many patients achieved reductions without severe hypoglycaemia with FORXIGA vs placebo. FORXIGA 5 mg is only indicated in adult type 1 diabetes patients with a BMI of ≥27 kg/m2.1 * The information presented here is from DEPICT-1. DEPICT-2 also demonstrated a higher proportion of FORXIGA patients achieving this outcome: 39.5% in the 5-mg arm and 20.1% in the placebo arm; odds ratio 2.71 (95% Cl: 1.81 to 4.06).2,3 †Severe hypoglycaemia required assistance of another person to raise glucose levels and promote neurological recovery.4 BMI=body mass index; T1D=type 1 diabetes. References: 1. FORXIGA. Summary of Product Characteristics. 2019. AstraZeneca UK Ltd. 2. Dandona P, Mathieu C, Phillip M, et al; on behalf of the DEPICT-1 Investigators. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2017;5:864-876. 3. Mathieu C, Dandona P, Gillard P, et al; on behalf of DEPICT-2 Investigators. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT-2 Study): 24-week results from a randomized controlled trial. Diabetes Care. 2018. doi:10.2337/dc18-0623. 4. Danne T, Nimri R, Battelino T, et al. International consensus on use of continuous glucose monitoring. Diabetes Care. 2017;40(12):1631–1640. 10 h 26 min 12 h 24 min 12 h 30 min 10 h 20 min 1 h 10 min 24 h 12 h 18 h 6 h 24 h 12 h 18 h 6 h 1 h 7 min ≤70mg/dL >180mg/dL >70 to ≤180mg/dL In adults with T1D, as an adjunct

In adults with T1D, as an adjunct to insulin

PATIENTS SPEND MORE THAN HALF THEIR DAY WITHIN TARGET GLUCOSE RANGE WITH FORXIGA 5 mg6

PATIENTS SPEND MORE THAN HALF THEIR DAY WITHIN TARGET GLUCOSE RANGE WITH FORXIGA 5mg6
PATIENTS SPEND MORE THAN HALF THEIR DAY WITHIN TARGET GLUCOSE RANGE WITH FORXIGA 5mg6
  • Forxiga 5 mg extended the time a patient spent in target glycaemic range by more than 2 hours per day6
  • Forxiga 5 mg led to relative increases in mean continuous glucose-monitoring values in the target glucose range of 20%6

In adults with T1D, as an adjunct to insulin,

FORXIGA 5 mg OFFERS PATIENTS THE ADDITIONAL BENEFIT OF WEIGHT REDUCTIONS1,4¥

FORXIGA 5mg OFFERS PATIENTS THE ADDITIONAL BENEFIT OF WEIGHT REDUCTIONS
FORXIGA 5mg OFFERS PATIENTS THE ADDITIONAL BENEFIT OF WEIGHT REDUCTIONS

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Forxiga 5 mg + insulin (n=259): (n=259) mean baseline body weight 81.67 kg4 Placebo + insulin (n=260): (n=260) mean baseline body weight was 84.42 kg4
¥Forxiga is not indicated for the management of weight loss. Weight change was a secondary endpoint in clinical trials.

  • The information presented here is from DEPICT-1. DEPICT-2 also showed reductions of 2.5 kg with Forxiga 5 mg (p<0.0001 vs placebo)1,3
  • Body weight reductions mostly occurred within the first 8 weeks and continued thereafter, reaching almost 3 kg by Week 24 (P<0.0001)1

FORXIGA T1D SAFETY

References:

  1. Dandona P, Mathieu C, Phillip M, et al; on behalf of the DEPICT-1 Investigators. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2017;5:864-876.
  2. Mathieu C, Dandona P, Gillard P, et al. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT-2 Study): 24-week results from a randomized controlled trial. Diabetes Care. 2018 (suppl):10.2337/dc18-0623.
  3. Mathieu C, Dandona P, Gillard P, et al. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT-2 Study): 24-week results from a randomized controlled trial. Diabetes Care. 2018;41:1938-1946.
  4. Forxiga. Summary of Product Characteristics. 2019. AstraZeneca.
  5. Danne T, Nimri R, Battelino T, et al. International consensus on use of continuous glucose monitoring. Diabetes Care. 2017;40(12):1631–1640.
  6. Rudofsky G. Long-term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes—the DEPICT-2 study. Presented at: 18th International Congress of Endocrinology; December 1-4, 2018; Cape Town, South Africa.
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