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

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; change in mean fasting plasma glucose (FPG) at Week 40; change in PPG increment (difference between the postprandial and preprandial glucose values across the 3 main meals from an 7-point self-measured plasma glucose (SMPG) profile 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 ER 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: 30-week, randomized, open-label, active-controlled, parallel-group, multinational, multicenter 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 (48%) or in combination with a sulfonylurea (51%) 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 (n=360). Patients assigned to insulin glargine had a baseline mean A1C of 8.1% and were started on a dose of 10 units once daily. Insulin glargine dose adjustments occurred throughout the trial period based on self-measured fasting plasma glucose before breakfast, targeting 71 to <100 mg/dL. In addition, investigators could titrate insulin glargine based on their discretion between study visits. Twenty-six percent 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 at Week 30; proportion of patients achieving A1C <7% at Week 30; change in mean fasting plasma glucose (FPG) at Week 30; change in PPG increment (difference between the postprandial and preprandial glucose values across the 3 main meals from an 8-point self-measured plasma glucose (SMPG) profile at Week 30).

Study design: 30-week, multinational, randomized, double-blind, parallel-group, placebo-controlled trial comparing the efficacy and safety of adding Ozempic^® 1 mg to SGLT-2i ± metformin/sulfonylurea vs placebo + SGLT-2i ± metformin/sulfonylurea. Patients were on SGLT-2i for an average of approximately 46 weeks at randomization.⁶

Patients: A total of 302 adult patients with type 2 diabetes inadequately controlled on SGLT-2i ± metformin/sulfonylurea were randomized to receive Ozempic^® 1 mg (n=151) once weekly or volume-matched placebo (n=151) as an add-on to SGLT-2i ± metformin/sulfonylurea.

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

Secondary endpoints: Mean change in body weight at Week 30; proportion of patients achieving A1C <7% at Week 30; change in mean fasting plasma glucose (FPG) at Week 30; change in PPG increment—defined as the difference between the postprandial glucose and preprandial glucose values across the 3 main meals from a 7-point SMPG (self-measured plasma glucose) profile.

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: 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: 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.