Consider once-weekly Ozempic^® for your adult patients with type 2 diabetes

Study design: 56-week, randomized, double-blind, double-dummy, active-controlled, parallel-group, multinational, multicenter trial to compare the efficacy and safety of Ozempic^® vs sitagliptin.

Patients: A total of 1231 adult patients with type 2 diabetes inadequately controlled on metformin and/or thiazolidinediones were randomized to receive once-weekly Ozempic^® 0.5 mg (n=409), once-weekly Ozempic^® 1 mg (n=409), or once-daily sitagliptin 100 mg (n=407), all in combination with metformin (94%) and/or thiazolidinediones (6%). 

Primary endpoint: Mean change in A1C from baseline at Week 56.

Secondary endpoints: Mean change in body weight from baseline at Week 56; proportion of patients achieving A1C <7% at Week 56.

Study design: 40-week, multinational, multicenter, randomized, open-label, 4-armed, pair-wise, active-controlled, parallel-group trial to compare the efficacy and safety of Ozempic^® vs dulaglutide.

Patients: A total of 1201 adult patients with type 2 diabetes inadequately controlled on metformin were randomized to receive Ozempic^® 0.5 mg (n=301), Ozempic^® 1 mg (n=300), dulaglutide 0.75 mg (n=299), or dulaglutide 1.5 mg (n=299) once weekly.

Primary endpoint: Mean change in A1C from baseline at Week 40.

Secondary endpoints: Mean change in body weight from baseline at Week 40; proportion of patients achieving A1C <7% at Week 40.

Study design: 56-week, randomized, open-label, active-controlled, parallel-group, multinational, multicenter trial to compare the efficacy and safety of Ozempic^® vs exenatide ER.

Patients: A total of 813 patients with type 2 diabetes on metformin alone (49%), metformin with sulfonylurea (45%), or others (6%) were randomized to receive once-weekly Ozempic^® 1 mg (n=404) or exenatide 2 mg (n=405). All treatment arms were in combination with metformin or metformin and sulfonylurea. 

Primary endpoint: Mean change in A1C from baseline at Week 56.

Secondary endpoints: Mean change in body weight from baseline at Week 56; proportion of patients achieving A1C <7% at Week 56.

Study design: 2-year, randomized, multinational, double-blind, placebo-controlled, parallel-group CV safety trial that was designed to access noninferiority of Ozempic^® vs standard of care by excluding the preapproval noninferiority margin of 1.8.

Patients: A total of 3297 adult patients with type 2 diabetes and high risk of CV events were randomized based on evidence of CV disease, insulin treatment, and renal impairment to once-weekly Ozempic^® 0.5 mg (n=826), once-weekly Ozempic^® 1 mg (n=822), or placebo (n=1649) in addition to standard of care treatments such as oral antidiabetic treatments, insulin, antihypertensives, diuretics, lipid-lowering therapies, and antithrombotic medications at investigator discretion.

Primary component endpoint: Time from randomization to first occurrence of a major adverse cardiovascular event (MACE) defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.

Study design: 30-week, randomized, double-blind, placebo-controlled, parallel-group, multinational, multicenter trial to evaluate the efficacy and safety of Ozempic^® vs placebo.

Patients: A total of 388 adult patients with type 2 diabetes inadequately controlled with diet and exercise were randomized to receive once-weekly Ozempic^® 0.5 mg (n=128), once-weekly Ozempic^® 1 mg (n=130), or placebo (n=129).

Primary endpoint: Mean change in A1C from baseline at Week 30.

Secondary endpoints: Mean change in body weight from baseline at Week 30; proportion of patients achieving A1C <7% at Week 30.

Ozempic^® is not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise.

Study design: 30-week, randomized, open-label, active-controlled, parallel-group, multinational, multicenter, treat-to-target trial to compare the efficacy and safety of Ozempic^® vs insulin glargine U-100.

Patients: A total of 1089 insulin-naïve adult patients with type 2 diabetes inadequately controlled on metformin alone or in combination with a sulfonylurea were randomized to receive once-weekly Ozempic^® 0.5 mg (n=362), once-weekly Ozempic^® 1 mg (n=360), or once-daily insulin glargine U-100 with a starting dose of 10 units (n=360). Only 26% of patients had been titrated to goal by the primary endpoint at Week 30, at which time the mean daily insulin dose was 29 units per day.

Primary endpoint: Mean change in A1C from baseline at Week 30.

Secondary endpoints: Mean change in body weight from baseline at Week 30; proportion of patients achieving A1C <7% at Week 30.

Study design: 30-week, randomized, double-blind, placebo-controlled, parallel-group, multinational, multicenter trial to compare the efficacy and safety of Ozempic^® in combination with basal insulin vs placebo.

Patients: A total of 397 adult patients inadequately controlled on basal insulin with or without metformin were randomized to once-weekly Ozempic^® 0.5 mg (n=132), Ozempic^® 1 mg (n=131), or placebo (n=133). Randomization was stratified according to A1C at screening. Patients with A1C ≤8% at screening reduced the insulin dose by 20% at start of trial to reduce the risk of hypoglycemia.

Primary endpoint: Mean change in A1C from baseline at Week 30.

Secondary endpoints: Mean change in body weight from baseline at Week 30; proportion of patients achieving A1C <7% at Week 30.