Information for healthcare professionals

NEW. Now available in Canada

Ozempic®. For adults with type 2 diabetes to improve glycemic control, when diet and exercise plus maximal tolerated metformin dose alone do not achieve adequate glycemic control.

See the new Ozempic® A1C and weight data
(2° endpoint – Ozempic® is not indicated for weight reduction; data vs Trulicity®)

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NEW A1C AND WEIGHT DATA

See below for results from a trial comparing
Ozempic® with Trulicity® (dulaglutide)

November, 2018

The SUSTAIN 7 trial was an open-label, parallel-group, phase 3b trial done at 194 hospitals, clinical institutions or private practices in 16 countries. Eligible patients were aged 18 years or older and had type 2 diabetes with A1C 7.0–10.5% (53.0–91.0 mmol/mol) on metformin monotherapy. Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once-a-week treatment with either Ozempic® 0.5 mg, Trulicity® 0.75 mg, Ozempic® 1.0 mg, or Trulicity® 1.5 mg subcutaneously. The primary endpoint was change from baseline in percentage A1C; the confirmatory secondary endpoint was change in bodyweight, both at week 40. The trial was powered for A1C non-inferiority (margin 0.4%) and bodyweight superiority.2

Highlights

At week 40, patients on Ozempic® 1 mg once weekly as an add-on to metformin experienced:
1.8% reduction in A1C from baseline (n=300, baseline 8.2%)2
6.5 kg weight loss from baseline (baseline 95.5 kg)2 (Ozempic® is not indicated for weight loss)

A1C

Demonstrated superior A1C reduction vs. Trulicity®, both as add-ons to metformin (p<0.0001)

At 40 weeks, patients on Ozempic® 0.5 mg once weekly saw a 1.5% reduction in A1C (n=301, baseline 8.3%) and patients on Ozempic® 1 mg once weekly experienced a 1.8% A1C reduction (n=300, baseline 8.2%) compared with patients on Trulicity® 0.75 mg who saw a 1.1% reduction (n=299, baseline 8.2%) and those on Trulicity® 1.5 mg who saw a 1.4% reduction (n=299, baseline 8.2%). Both Ozempic® 0.5 mg and Ozempic® 1 mg showed statistically significant reductions versus Trulicity® 0.75 mg and 1.5 mg, respectively (p<0.0001).2

Patients who achieved A1C of <7%
At 40 weeks, 68% of patients on Ozempic® 0.5 mg and 79% of patients on Ozempic® 1 mg once weekly achieved an A1C of <7.0%. 52% of patients on Trulicity® 0.75 mg and 67% on Trulicity® 1.5 mg achieved an A1C of <7.0%.2

Weight

Demonstrated statistically significant weight reduction vs. Trulicity®, both as add-ons to metformin (2° endpoint, p<0.0001)

At 40 weeks, patients on Ozempic® 0.5 mg once weekly demonstrated weight loss of 4.6 kg (baseline 96.4 kg) while patients on Ozempic® 1 mg demonstrated weight loss of 6.5 kg (baseline 95.5 kg). Patients on Trulicity® 0.75 mg demonstrated weight loss of 2.3 kg (baseline 95.6 kg) while those on Trulicity® 1.5 mg demonstrated weight loss of 3.0 kg (baseline 93.4 kg). Ozempic® showed more than 2x the weight change versus Trulicity®, both as add-ons to metformin (p<0.0001).2 (Ozempic® is not indicated for weight reduction.)

OZEMPIC® VERSUS JANUVIA® (SITAGLIPTIN)

See below for results from a trial
comparing Ozempic® with Januvia®

January 4, 2018

The SUSTAIN 2 trial was a 56-week, randomized, double-blind, double-dummy, active-controlled, parallel-group trial in which 1231 patients were randomized 2:2:1:1 to Ozempic® 0.5 mg/Januvia® placebo, Ozempic® 1 mg/Januvia® placebo, Januvia®/Ozempic® 0.5 mg placebo or Januvia®/Ozempic® 1.0 mg placebo, all in combination with metformin (94%) and/or TZD (6%). Subjects continued pre-trial background medication throughout the entire trial. The primary objective was to compare the effect of once weekly dosing of 2 dose levels of Ozempic® vs. Januvia® 100 mg once daily on glycemic control after 56 weeks of treatment.1

Demonstrated A1C reductions
At 56 weeks, patients on Ozempic® 0.5 mg once weekly saw a 1.3% reduction in A1C and those on Ozempic® 1 mg once weekly experienced a 1.5% reduction (both groups n=409, baseline 8.0; p<0.0001) compared with patients on Januvia® 100 mg who saw a 0.7% reduction (n=407, baseline 8.2). Both Ozempic® 0.5 mg and Ozempic® 1 mg showed statistically significant reductions versus Januvia®.1

Patients who achieved A1C of <7%
At 56 weeks, 66% of patients on Ozempic® 0.5 mg and 73% of patients on Ozempic® 1 mg once weekly achieved an A1C of <7.0%. 40% of patients on Januvia® 100 mg achieved an A1C of <7.0%.1

Demonstrated weight change
Patients on Ozempic® 0.5 mg once weekly demonstrated weight change of -4.2 kg (baseline 89.9 kg) while patients on Ozempic® 1 mg demonstrated weight change of -5.5 kg (baseline 89.2 kg). Patients on Januvia® 100 mg demonstrated weight change of -1.7 kg (baseline 89.3 kg).1 (Ozempic® is not indicated for weight loss).1

DEMONSTRATED CARDIOVASCULAR OUTCOMES

No increase in major adverse cardiovascular events
demonstrated with Ozempic® (estimated hazard ratio 0.74
[95% CI; 0.58-0.95]; actual risk reduction=2.3%)1

January 4, 2018

In one large study looking at cardiovascular safety with Ozempic®, there was no increased risk for time to first major adverse cardiovascular event (MACE; components of MACE are cardiovascular death, non-fatal stroke, and non-fatal myocardial infarction) versus placebo.1

The SUSTAIN 6 trial was a 104-week, double-blind trial in which 3,297 patients with type 2 diabetes and high risk of cardiovascular events were randomized to Ozempic® 0.5 mg once weekly, Ozempic® 1 mg once weekly, or placebo in addition to standard of care. The primary objective of the trial was to confirm that treatment with Ozempic® does not result in any unacceptable increase in cardiovascular risk as compared to placebo in adults with type 2 diabetes. This was done by demonstrating that the upper limit of the two-sided 95% confidence interval (CI) of the hazard ratio for Ozempic® versus placebo is less than 1.8 when comparing time to first occurrence of a major adverse cardiovascular event.

There was no increased risk for MACE observed with Ozempic®. The estimated hazard ratio of MACE associated with Ozempic® relative to placebo was 0.74 with a 95% CI of (0.58, 0.95).1

OZEMPIC® IS NOW AVAILABLE IN CANADA

A new once weekly GLP-1 RA
treatment option in type 2 diabetes

January 4, 2018

Ozempic® has launched in Canada, offering type 2 diabetes patients a new option.

Ozempic® is indicated for the once-weekly treatment of adult patients with type 2 diabetes mellitus to improve glycemic control, in combination with:1

  • diet and exercise in patients for whom metformin is inappropriate due to contraindication or intolerance
  • metformin, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate glycemic control
  • metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not achieve adequate glycemic control
  • basal insulin with metformin, when diet and exercise plus basal insulin with metformin do not achieve adequate glycemic control

Learn more about what Ozempic® can do for your patients in future articles.

Comparative clinical significance has not been established.
GLP-1=glucagon-like peptide-1; RA=receptor agonist; MET=metformin

Resources

The latest Ozempic® Product Monograph

Download

Patient Diary

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Patient Brochure

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Dosing Poster

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Pharmacist Announcement Letter

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