Victoza® is not indicated for weight loss.
Victoza® efficacy and safety for patients with type 2 diabetes
Consider a once-weekly GLP‑1 RA therapy
Ozempic® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction or nonfatal stroke) in adults with type 2 diabetes mellitus and established CVD.
See how once-weekly Ozempic® compared head-to-head vs Trulicity®
Studies in adults with type 2 diabetes
In a head-to-head study in adults with type 2 diabetes
Victoza® consistently outperformed Januvia®1
Primary endpoint: Mean change in A1C from baseline
Studied in adults with type 2 diabetes taking metformin.
aP<0.0001 vs Januvia®.
In a head-to-head study in adults with type 2 diabetes
Victoza® provided significant weight reduction vs Januvia®1
Secondary endpoint: Mean change in weight from baseline
Studied in adults with type 2 diabetes taking metformin.
Pratley (1860)1
Study-related adverse events
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%).
Study design
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 head-to-head study in adults with type 2 diabetes
Victoza® was unsurpassed in A1C reduction vs Trulicity®2
Primary endpoint: Mean change in A1C from baseline
Studied in adults with type 2 diabetes taking OADs. Upper limit of the 95% CI (-0.19; 0.07) was less than prespecified noninferiority margin of 0.4%.
bStudy sponsored by Eli Lilly and Company.
In a head-to-head study in adults with type 2 diabetes
Victoza® provided significant weight reduction vs Trulicity®2
Secondary endpoint: Mean change in weight from baseline
After 26 weeks
Victoza® vs Trulicity®b
Baseline weight:
206 to 208 lb
23% greater weight loss
Studied in adults with type 2 diabetes taking OADs.
bStudy sponsored by Eli Lilly and Company.
Victoza® is not indicated for weight loss.
AWARD-62
Study-related adverse events
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.
Study design
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.
In a head-to-head study in adults with type 2 diabetes
Victoza® demonstrated powerful A1C reductions after patients switched from Januvia®3
Primary endpoint: Mean change in A1C from baseline
Studied in adults with type 2 diabetes taking metformin.
aP<0.0001 vs Januvia®.
In a head-to-head study in adults with type 2 diabetes
Victoza® provided significant weight reduction after switching from Januvia®3
Secondary endpoint: Mean change in weight from baseline
After 26 weeks
Switch to Victoza® after Januvia®
Baseline weight:
196 to 201 lb
2X greater weight loss
Studied in adults with type 2 diabetes taking metformin.
Victoza® is not indicated for weight loss.
Bailey (LIRA-SWITCH)3
Study-related adverse events
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%).
Study design
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.
No dosage adjustment recommended for patients with renal impairment4
Mild
Moderate
Severe
There is limited experience with Victoza® in patients with end stage renal disease.
Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment.
Victoza® is not filtered by the kidneys5
In the LIRA-RENAL study, Victoza® showed no significant difference in renal function vs placebo as measured by eGFR, as a safety endpoint.6
Change from average baseline eGFR of 45 mL/min/1.73 m2:
-0.35 mL/min/1.73m2
with Victoza® 1.8 mg (P=0.36)
+0.37 mL/min/1.73m2
with placebo
For adult patients with type 2 diabetes and moderatec renal impairment
Victoza® provided significant A1C reductions and the additional benefit of weight loss over 26 weeks6
Primary endpoint: Average A1C reductions
Baseline A1C 8.0% to 8.1%
Secondary endpoint: Average weight loss
Baseline weight 206 lb to 201 lb
Victoza® is not indicated for weight loss.
cMild renal impairment=eGFR 60 to ≤89 mL/min/1.73m2; moderate renal impairment=eGFR 30-59 mL/min/1.73m2; severe renal impairment=eGFR <30 mL/min/1.73m2.
dP<0.0001.
Davies (LIRA-RENAL)6
Study-related adverse events
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 rate decreased (6.4% vs 5.1%), and headache (5.0% vs 2.9%).
Study design
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; up titration of insulin was allowed but not beyond the pre-trial dose.
Victoza® was superior in reducing A1C from baseline versus placebo at 26 weeks4
Average adjusted A1C reductionsa
Victoza® + MET ± basal insulin
From mean baseline A1C: 7.7% to 7.9%
Overall, the type, and severity of adverse reactions in adolescents and children aged 10 years and above were comparable to that observed in the adult population.
In pediatric patients 10 years of age and older, the risk of hypoglycemia was higher with Victoza® regardless of insulin and/or metformin use.
The change from baseline to end-of-treatment visit in A1C was analyzed using a pattern mixture model with multiple imputation. Missing observations (10.6% in the Victoza®, 14.5% in the placebo) were imputed from the placebo arm based on multiple (x10,000) imputations. The data for week 26 was then analyzed with an ANCOVA model containing treatment, sex, and age group as fixed effects and baseline value as covariate.
Study design
ELLIPSE7
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 10-17 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.
CKD=chronic kidney disease; DPP-4=dipeptidyl peptidase-4; eGFR=estimated glomerular filtration rate; GLP-1 RA=glucagon-like peptide-1 receptor agonist; OAD=oral antidiabetic drug.