A 26-week, open-label, active-comparator, 3-armed, parallel-group trial to compare the efficacy and safety of Victoza^® with sitagliptin for the treatment of type 2 diabetes in adults. Patients with type 2 diabetes inadequately controlled on metformin (N=665) were randomized to receive once-daily Victoza^® 1.2 mg (n=225), Victoza^® 1.8 mg (n=221), or sitagliptin 100 mg (n=219). The primary outcome was change in A1C.

In a 26-week, open-label study in adult patients (N=665) comparing Victoza^® 1.2 mg, Victoza^® 1.8 mg, and sitagliptin 100 mg, all in combination with metformin, the adverse reactions reported in ≥5% of patients treated with Victoza^® were nausea (23.9% vs 4.6%), headache (10.3% vs 10.0%), diarrhea (9.3% vs 4.6%), and vomiting (8.7% vs 4.1%).

A 26-week, randomized, open-label, parallel-group, multicenter (62 sites), multinational (9 countries), phase 3, noninferiority study. Patients were included based on the following criteria: adults with type 2 diabetes, treated with metformin, A1C of 7% to 10%, and a BMI of up to 45 kg/m². Patients (N=599) were randomized to receive once-weekly Trulicity^® 1.5 mg (n=299) or once-daily Victoza^® 1.8 mg (n=300). The primary endpoint was change in A1C. Study sponsored by Eli Lilly and Company.

The most common adverse events occurring in 5% or more of adult patients in the treatment groups combined (Victoza^® 1.8 mg vs dulaglutide 1.5 mg): nausea (18% vs 20%); diarrhea (12% vs 12%); vomiting (8% vs 7%); dyspepsia (6% vs 8%); constipation (6% vs 4%); nasopharyngitis (7% vs 8%); headache (8% vs 7%); back pain (5% vs 4%); decreased appetite (7% vs 5%); and minor hypoglycemia (6% vs 9%). No major hypoglycemia occurred.

A 26-week, randomized, parallel-group, double-blind, double-dummy, active-controlled study to compare efficacy and safety in patients switching from Januvia^® 100 mg to Victoza^® 1.8 mg with patients who stayed on Januvia^®. Adult patients with type 2 diabetes inadequately controlled on metformin (≥1500 mg/day) and Januvia^® (100 mg/day) for at least 90 days prior to screening (N=407) were randomized 1:1 to switch to once-daily Victoza^® 1.8 mg in addition to a Januvia^® placebo or continued Januvia^® 100 mg in addition to a Victoza^® placebo, both in combination with metformin. The primary endpoint was a change in A1C.

The adverse events most commonly reported in ≥5% of adult patients treated with Victoza^® 1.8 mg vs Januvia^® 100 mg, both in combination with metformin, were nausea (21.8% vs 7.8%), diarrhea (16.3% vs 9.3%), decreased appetite (8.9% vs 3.4%), vomiting (7.4% vs 4.9%), headache (6.4% vs 5.9%), nasopharyngitis (5.9% vs 3.4%), and increased lipase (5.5% vs 4.4%).

A 26-week, double-blind, placebo-controlled, parallel-group, randomized study in adult patients with type 2 diabetes and moderate renal impairment (eGFR 30-59 mL/min/1.73 m²). Patients were randomized to receive Victoza^® 1.8 mg (n=140) or placebo (n=139) in addition to existing oral antidiabetics and/or insulin therapy. The primary endpoint was change in A1C. The insulin dose was reduced by 20% at randomization for patients with baseline A1C ≤8% and fixed until liraglutide dose escalation was complete. Dose reduction of insulin and SU was allowed in case of hypoglycemia; uptitration of insulin was allowed but not beyond the pretrial dose.

Adverse reactions reported in ≥5% of patients and occurring more frequently with Victoza^® compared with placebo included nausea (21.4% vs 4.4%), vomiting (12.1% vs 2.2%), diarrhea (7.1% vs 2.9%), constipation (5.7% vs 1.5%), increased lipase (15.0% vs 8.8%), GFR decreased (6.4% vs 5.1%), and headache (5.0% vs 2.9%).

A 26-week, randomized, parallel-group, placebo-controlled trial with a 26-week double-blind period followed by a 26-week open-label extension. Eligible patients (N=135) between the ages of 10-17 years had A1C levels between 7%-11% if they were being treated with diet and exercise alone or between 6.5%-11% if they were being treated with metformin (with or without insulin) and had a body mass index (BMI) greater than the 85th percentile. Patients were randomized (1:1) to receive once-daily Victoza^® (n=66) or placebo (n=68) for 26 weeks in combination with metformin with or without basal insulin on a background of diet and exercise regimen.

The treatment (Victoza^® or placebo) was unblinded after the 26-week visit, and the trial was continued for an additional 26-week open-label extension. The basal insulin dose was decreased by 20% at randomization, and Victoza^® was initiated at 0.6 mg/day and was titrated to 1.2 mg and 1.8 mg over the course of 2-3 weeks based on tolerability and an average fasting plasma glucose goal of ≤110 mg/dL. The primary endpoint was change in A1C from baseline at 26 weeks.

A phase 3b, multicenter, international, randomized, double-blind, placebo-controlled study to assess the cardiovascular safety of Victoza^®. Adult patients with type 2 diabetes at high risk for cardiovascular events (N=9340) were randomized to receive once-daily Victoza^® (0.6 mg-1.8 mg once daily with all patients being titrated to 1.8 mg once daily) or placebo. The primary endpoint was the time from randomization to a composite outcome consisting of the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. The trial was prospectively designed and powered to assess whether Victoza^® was noninferior or superior to placebo when measuring effect on CV events. Patients received trial products in addition to standard of care treatments such as oral antidiabetic treatments, insulin, and antihypertensive, antiplatelet, and lipid-lowering therapies.