In patients with type 2 diabetes at high CV risk

Ozempic® reduced the risk of CV events within 2 years1,5*

Time to first confirmed major adverse CV event (MACE)5

Hazard ratio, 0.74 (95% CI, 0.58-0.95)
P<0.001 for noninferiority
P=0.02 for superiority

8.9%
Placebo
+ SOC

6.6%
Ozempic®
+ SOC

Weeks since randomisation

Patients with event (%)

  • 10

  • 8

  • 6

  • 4

  • 2

  • 0

  • 0

  • 8

  • 16

  • 24

  • 32

  • 40

  • 48

  • 56

  • 64

  • 72

  • 80

  • 88

  • 96

  • 104

WHEN ADDED TO STANDARD OF CARE

VS PLACEBO5

Components of the composite primary outcome (MACE)1,5

Nonfatal stroke=–39%

Nonfatal MI=–26%

CV death=–2%

[HR=0.61 (95% CI,
0.38-0.99; P=0.04)]

[HR=0.74 (95% CI,
0.51-1.08; P=0.12)]

[HR=0.98 (95% CI,
0.65-1.48; P=0.92)]

CV=cardiovascular; CI=confidence interval;

SOC=standard of care; MI=myocardial infarction.

*When added to SOC.1

Testing for superiority for the

primary outcome was not prespecified.5

SOC included oral antidiabetic treatments, insulin,

antihypertensives, diuretics and lipid-lowering therapies.8

CV RISK

CV RISK

SUSTAINED DATA

SUSTAINED DATA

TRIAL DETAILS

TRIAL DETAILS

CVOTs

CVOTs

x

CV DISEASE IS THE

#1

CAUSE OF DEATH

AND DISABILITY IN
 TYPE 2 DIABETES WORLDWIDE15

PATIENTS WITH
 TYPE 2 DIABETES HAVE

UP TO
4X GREATER

RISK

OF

CORONARY ARTERY
DISEASE AND STROKE

THAN THOSE WITHOUT TYPE 2 DIABETES16

CV=cardiovascular.

x

SUSTAIN 6: A 2-year CVOT for Ozempic®1

3297 PATIENTS1,5

Inclusion criteria:

T2D, HbA1c ≥7%

Age ≥60 years with at least
1 CV risk factor

OR

Age ≥50 years with
established CV disease

CVOT=cardiovascular outcomes trial; T2D=type 2 diabetes; CV=cardiovascular; SOC=standard of care; MI=myocardial infarction.

1:1:1:1 randomisation1

Primary composite outcome1,5

Randomisation to first
occurrence of:

CV death

Nonfatal MI

Nonfatal stroke

Treatment duration 2 years

Ozempic® 1 mg

Ozempic® 0.5 mg

Placebo 1 mg

Placebo 0.5 mg

Diabetes
and
CV SOC

x

Ozempic®—clinically meaningful weight loss and glycaemic control at 2 years5

Weight reductions from baseline over 2 years5*

P<0.001

Mean body weight (kg)

Change from baseline

Placebo 1 mg  –0.5 kg

Placebo 0.5 mg  –0.7 kg

Ozempic® 0.5 mg  –3.6 kg

Ozempic® 1 mg  –4.9 kg

Weeks since randomisation

Mean body weight at baseline: 92.1 kg

Patients also experienced significant HbA1c reductions at 2 years5

At 2 years, Ozempic® 1 mg* provided an HbA1c reduction of up

to 1.4% vs 0.4% for placebo* (P<0.001)

–1.4%

SIGNIFICANT WEIGHT LOSS

*When added to standard of care.1,5

  • 93

  • 92

  • 91

  • 90

  • 89

  • 88

  • 87

  • 0

  • 1.0

  • 0.0

  • –1.0

  • –2.0

  • –3.0

  • –4.0

  • –5.0

0

8

16

30

44

56

68

80

92

104

x

Cardiovascular outcomes trials in type 2 diabetes: An overview

REWIND12

(dulaglutide vs placebo)

LEADER25,26

(liraglutide vs placebo)

EMPA-REG14,27

(empagliflozin vs placebo)

SUSTAIN 65

(semaglutide vs placebo)

MACE

MACE

MACE

MACE

RRR

RRR

RRR

RRR

12%

13%

14%

26%

P=0.026

P=0.01

P=0.004

P<0.001 for noninferiority

P=0.02 for superiority

CV death*=–9%

[HR=0.91 (95% CI, 0.78-1.06; P=0.21)]

CV death=–22%

[HR=0.78 (95% Cl, 0.66-0.93; P=0.007)]

CV death=–38%

[HR=0.62 (95% Cl, 0.49-0.77; P<0.001)]

CV death=–2%

[HR=0.98 (95% Cl, 0.65-1.48; P=0.92)]

Nonfatal stroke=–24%

[HR=0.76 (95% CI, 0.61-0.95; P=0.017)]

Nonfatal stroke=–11%

[HR=0.89 (95% Cl, 0.72-1.11; P=0.30)]

Nonfatal stroke=24%

[HR=1.24 (95% Cl, 0.92-1.67; P=0.16)]

Nonfatal stroke=–39%

[HR=0.61 (95% CI, 0.38-0.99; P=0.04)]

Nonfatal MI=–4%

[HR=0.96 (95% CI, 0.79-1.16; P=0.65)]

Nonfatal MI=–12%

[HR=0.88 (95% Cl, 0.75-1.03; P=0.11)]

Nonfatal MI=–13%

[HR=0.87 (95% Cl, 0.70-1.09; P=0.22)]

Nonfatal MI=–26%

[HR=0.74 (95% CI, 0.51-1.08; P=0.12)]

Please note that CVOTs are different in trial designs. Therefore, results cannot be
used as a head-to-head comparison.

MACE=major adverse cardiovascular event; RRR=relative risk reduction; HR=hazard ratio; CI=confidence interval; MI=myocardial infarction;

*Includes deaths of unknown cause.

Testing for superiority for the primary outcome was not prespecified.5

BASELINE CRITERIA
CVOTs
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Baseline criteria

REWIND11,12

(dulaglutide vs placebo)

LEADER25,26

(liraglutide vs placebo)

EMPA-REG14,27

(empagliflozin vs placebo)

SUSTAIN 65,8

(semaglutide vs placebo)

CV RISK

31% established CVD

82% established CVD

99% established CVD

83% established CVD

CV HISTORY

PRIOR MI

16.2%

31%

47%

33%

HEART FAILURE

8.6%

18%

10%

24%

MEAN DIABETES

DURATION

9.5 years

13 years

>10 years

14 years

MEAN HbA1c

7.2%

8.7%

8.1%

8.7%

INSULIN USE

24%

44.6%

48%

58%

TRIAL DURATION

5.4 years

Mean 3.8 years

Mean 3.1 years

2 years

Please note that CVOTs are different in trial designs. Therefore, results cannot be
used as a head-to-head comparison.

CV=cardiovascular; CVD=cardiovascular disease; CVOT=cardiovascular outcomes trial.