OZEMPIC Rx

Monotherapy Use of Ozempic in Patients with Type 2 Diabetes Mellitus 

• The efficacy of Ozempic as monotherapy was evaluated in a 30-week double-blind trial (NCT02054897) in 388 patients with type 2 diabetes who were inadequately controlled with diet and exercise. Patients were randomly assigned to Ozempic 0.5mg or 1mg once weekly or placebo.

• Ozempic 0.5mg and 1mg once weekly achieved a statistically significant reduction in HbA1c at week 30 vs placebo. Patients treated with Ozempic 0.5mg had a change in HbA1c of -1.4% at week 30 (difference from placebo, -1.2 [95% CI, -1.5, -0.9]; P <.0001); patients treated with Ozempic 1mg had a change in HbA1c of -1.6% at week 30 (difference from placebo, -1.4 [95% CI, -1.7, -1.1]; P <.0001).

• Ozempic 0.5mg and 1mg treatment arms also had greater mean changes in body weight from baseline to week 30 vs placebo (-3.8kg, -4.7kg vs -1.2kg, respectively).

Combination Therapy Use of Ozempic in Patients with Type 2 Diabetes Mellitus 

Combination with metformin and/or thiazolidinediones

• The efficacy of Ozempic was evaluated in a 56-week double-blind trial (NCT01930188) in 1231 patients with type 2 diabetes. Patients were randomly assigned to Ozempic 0.5mg or 1mg once weekly or sitagliptin 100mg once daily, plus metformin (94%) and/or thiazolidinediones (6%).

• Ozempic 0.5mg and 1mg once weekly achieved a statistically significant reduction in HbA1c compared with sitaglitin.

• Patients treated with Ozempic 0.5mg had a change in HbA1c of -1.3% at week 56 (difference from sitagliptin, -0.6 [95% CI, -0.7, -0.4]; P <.0001); patients treated with Ozempic 1mg had a change in HbA1c of  -1.5% at week 56 (difference from sitagliptin, -0.8 [95% CI, -0.9, -0.6]; P <.0001).

• Ozempic 0.5mg and 1mg treatment arms also had greater mean changes in body weight from baseline to week 56 vs sitagliptin (-4.2kg, -5.5kg vs -1.7kg, respectively).

Combination with metformin or metformin with sulfonylurea

• The efficacy of Ozempic was evaluated in a 56-week open-label trial (NCT01885208) in 813 patients with type 2 diabetes on metformin alone (49%), metformin with sulfonylurea (45%), or other (6%). Patients were randomly assigned to Ozempic 1mg once weekly or exenatide 2mg once weekly.

• Ozempic 1mg once weekly achieved a statistically significant reduction in HbA1c compared with exenatide.

• Patients treated with Ozempic 1mg had a change in HbA1c of  -1.4% at week 56 (difference from exenatide, -0.5 [95% CI, -0.7, -0.3]; P <.0001).

• Ozempic 1mg treatment arms also had greater mean changes in body weight from baseline to week 56 vs exenatide (-4.8kg vs -2.0kg, respectively).

Combination with metformin or metformin with sulfonylurea

• The efficacy of Ozempic was evaluated in a 30-week open-label trial (NCT02128932) in 1089 patients with type 2 diabetes. Patients were randomly assigned to Ozempic 0.5mg or 1mg once weekly or insulin glargine once daily, plus background therapy with metformin (48%), or metformin and sulfonylurea (51%).

• Ozempic 0.5mg and 1mg once weekly achieved a statistically significant reduction in HbA1c compared with insulin glargine.

• Patients treated with Ozempic 0.5mg had a change in HbA1c of -1.2% at week 30 (difference from insulin glargine, -0.3 [95% CI, -0.5, -0.1]; P <.0001); patients treated with Ozempic 1mg had a change in HbA1c of -1.5% at week 30 (difference from  insulin glargine, -0.6 [95% CI, -0.8, -0.4]; P <.0001).

• Ozempic 0.5mg and 1mg treatment arms also had greater mean changes in body weight from baseline to week 30 vs insulin glargine (-3.2kg, -4.7kg vs 0.9kg, respectively).

Combination with metformin or metformin with sulfonylurea

• The efficacy of Ozempic was evaluated in a 40-week double-blind trial (NCT03989232) in 961 patients with type 2 diabetes currently treated with metformin with or without sulfonylurea. Patients were randomly assigned to Ozempic 2mg or 1mg once weekly.

• Ozempic 2mg once weekly achieved a statistically significant reduction in HbA1c compared with Ozempic 1mg.

• Patients treated with Ozempic 2mg had a change in HbA1c of -2.1% at week 40 (difference from Ozempic 1mg, -0.2 [95% CI, -0.31, -0.04]; P <.01).

• The Ozempic 2mg arm also had greater mean changes in body weight from baseline to week 40 vs Ozempic 1mg (-6.4kg vs -5.6kg, respectively). This was not statistically significant.

Combination with basal insulin

• The efficacy of Ozempic was evaluated in a 30-week double-blind trial (NCT02305381) in 397 patients with type 2 diabetes who are inadequately controlled with basal insulin, with or without metformin. Patients were randomly assigned to Ozempic 0.5mg or 1mg once weekly, or placebo.

• Ozempic 0.5mg and 1mg once weekly achieved a statistically significant reduction in HbA1c at week 30 compared with placebo.

• Patients treated with Ozempic 0.5mg had a change in HbA1c of -1.3% at week 30 (difference from placebo, -1.1 [95% CI, -1.4, -0.8]; P <.0001); patients treated with Ozempic 1mg had a change in HbA1c of -1.7% at week 30 (difference from placebo, -1.6 [95% CI, -1.8, -1.3]; P <.0001).

• Ozempic 0.5mg and 1mg treatment arms also had greater mean changes in body weight from baseline to week 30 vs placebo (-3.5kg, -6.0kg vs -1.2kg, respectively).

Cardiovascular Outcomes Trial of Ozempic in Patients with Type 2 Diabetes Mellitus and Cardiovascular Disease 

• The approval was based on data from the 2-year, multicenter, double-blind, placebo-controlled SUSTAIN 6 trial that assessed the risk of MACE when adding Ozempic or placebo to standard of care in adults with diabetes and established CV disease (N=3297). 

• Patients were randomly assigned 1:1 to receive Ozempic 0.5mg or 1mg once weekly or placebo. The primary endpoint was the time to first occurrence of MACE, defined as CV death, nonfatal myocardial infarction, or nonfatal stroke.

• Treatment with Ozempic significantly reduced the risk of MACE occurrence by 26% vs placebo (estimated hazard ratio [HR] for time to first MACE, 0.74 [95% CI, 0.58-0.95]; P <.001); the primary composite endpoint occurred in 6.6% of the Ozempic group vs 8.9% of the placebo arm.