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Victoza® efficacy and safety for patients with type 2 diabetes

Ozempic® (semaglutide) injection 0.5 mg or 1 mg

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

After 26 weeks

Victoza® vs Januvia®

Baseline A1C:
8.4% to 8.5%

Victoza® vs Januvia® A1C Reduction Clinical Trials
Victoza® vs Januvia® A1C Reduction Clinical Trials

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

After 26 weeks

Victoza® vs Januvia®

Baseline weight:
207 lb

Victoza® vs Januvia® Weight Reduction Clinical Trials
Victoza® vs Januvia® Weight Reduction Clinical Trials

Studied in adults with type 2 diabetes taking metformin.

Victoza® is not indicated for weight loss.

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

After 26 weeks

Victoza® vs Trulicity®b

Baseline A1C:
8.1%

A1C reduction chart: Victoza Vs Trulicity Chart
A1C reduction chart: Victoza Vs Trulicity Chart

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

Weight loss chart: Victoza® vs Trulicity®
Weight loss chart: Victoza® vs Trulicity®

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

After 26 weeks

Switch to Victoza® after Januvia®

Baseline A1C:
8.2% to 8.3%

Switch to Victoza® after Januvia® A1C chart
Switch to Victoza® after Januvia® A1C chart

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

Weight loss chart: Switch to Victoza® after Januvia®
Weight loss chart: Switch to Victoza® after Januvia®

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.

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No dosage adjustment recommended for patients with renal impairment4

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Mild

Check mark

Moderate

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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%

A1C reduction chart

Secondary endpoint: Average weight loss

Baseline weight 206 lb to 201 lb

Weight loss chart

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

secondary_msg

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%

A1C reduction chart
A1C reduction chart

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 concomitant antidiabetic therapies.

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.

Important Safety Information for Victoza® (liraglutide) injection

WARNING: RISK OF THYROID C-CELL TUMORS

  • Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.
  • Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Victoza® and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Victoza®.

Indication and Limitations of Use

Victoza® (liraglutide) injection 1.2 mg or 1.8 mg is indicated as an adjunct to diet and exercise to improve glycemic control in patients 10 years and older with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.

  • Victoza® should not be used in patients with type 1 diabetes mellitus or diabetic ketoacidosis.
  • Concurrent use with prandial insulin has not been studied.

Contraindications

  • Victoza® is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with Victoza®.

Warnings and Precautions

  • Risk of Thyroid C-cell Tumors: Patients should be referred to an endocrinologist for further evaluation if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging.
  • Pancreatitis: Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza® postmarketing. Observe patients carefully for signs and symptoms of pancreatitis (persistent severe abdominal pain, sometimes radiating to the back with or without vomiting). If pancreatitis is suspected, discontinue Victoza® promptly and if pancreatitis is confirmed, do not restart. Victoza® has been studied in a limited number of patients with a history of pancreatitis. It is unknown if patients with a history of pancreatitis are at a higher risk for development of pancreatitis on Victoza®.
  • Never Share a Victoza® Pen Between Patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens.
  • Hypoglycemia: When Victoza® is used with an insulin secretagogue (eg, a sulfonylurea) or insulin, serious hypoglycemia can occur. In pediatric patients 10 years of age and older, the risk of hypoglycemia was higher with Victoza® regardless of concomitant antidiabetic therapies.
  • Renal Impairment: Acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis, have been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment.
  • Hypersensitivity Reactions: Serious hypersensitivity reactions (eg, anaphylaxis and angioedema) have been reported post-marketing. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza®; treat promptly per standard of care, and monitor until signs and symptoms resolve. Do not use in patients with a previous hypersensitivity reaction to Victoza®. Anaphylaxis and angioedema have been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-receptor agonist because it is unknown whether such patients will be predisposed to these reactions with Victoza®.
  • Acute Gallbladder Disease: In the LEADER trial, 3.1% of Victoza® vs. 1.9% of placebo-treated patients reported an acute event of gallbladder disease, such as cholelithiasis or cholecystitis. The majority of events required hospitalization or cholecystectomy. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow up are indicated.

Adverse Reactions

  • The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are nausea, diarrhea, headache, vomiting, decreased appetite, dyspepsia, and constipation. Immunogenicity-related events, including urticaria, were more common among Victoza®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials.

Drug Interactions

  • Victoza® causes a delay of gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with Victoza®.
  • When initiating Victoza®, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia.

Use in Specific Populations

  • The safety and effectiveness of Victoza® have not been established in pediatric patients less than 10 years of age.
  • Victoza® slows gastric emptying. Victoza® has not been studied in patients with pre-existing gastroparesis.
  • Victoza® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Please click here for Victoza® Prescribing Information, including Boxed Warning.



Important Safety Information for Ozempic® (semaglutide) injection 0.5 mg or 1 mg

WARNING: RISK OF THYROID C-CELL TUMORS

  • In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Ozempic® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.
  • Ozempic® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Ozempic® and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Ozempic®.

Indication and Limitations of Use

Ozempic® (semaglutide) injection 0.5 mg or 1 mg 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 CV disease.

  • Ozempic® has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
  • Ozempic® is not a substitute for insulin. Ozempic® is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis.

Contraindications

  • Ozempic® is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with known hypersensitivity to semaglutide or to any of the product components.

Warnings and Precautions

  • Risk of Thyroid C-Cell Tumors: Patients should be referred to an endocrinologist for further evaluation if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging.
  • Pancreatitis: Acute and chronic pancreatitis have been reported in clinical studies. Observe patients carefully for signs and symptoms of pancreatitis (persistent severe abdominal pain, sometimes radiating to the back with or without vomiting). If pancreatitis is suspected, discontinue Ozempic® promptly, and if pancreatitis is confirmed, do not restart.
  • Diabetic Retinopathy Complications: In a 2-year trial involving patients with type 2 diabetes and high cardiovascular risk, more events of diabetic retinopathy complications occurred in patients treated with Ozempic® (3.0%) compared with placebo (1.8%). The absolute risk increase for diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline than among patients without a known history of diabetic retinopathy.
    Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. The effect of long-term glycemic control with semaglutide on diabetic retinopathy complications has not been studied. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.
  • Never Share an Ozempic® Pen Between Patients: Ozempic® pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens.
  • Hypoglycemia: The risk of hypoglycemia is increased when Ozempic® is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin.
  • Acute Kidney Injury: There have been postmarketing reports of acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis, in patients treated with GLP-1 receptor agonists. Some of these events have been 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. Monitor renal function when initiating or escalating doses of Ozempic® in patients reporting severe adverse gastrointestinal reactions.
  • Hypersensitivity: Serious hypersensitivity reactions (eg, anaphylaxis, angioedema) have been reported with GLP-1 receptor agonists. If hypersensitivity reactions occur, discontinue use of Ozempic®; treat promptly per standard of care, and monitor until signs and symptoms resolve. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist.

Adverse Reactions

  • The most common adverse reactions, reported in ≥5% of patients treated with Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation.

Drug Interactions

  • The risk of hypoglycemia may be lowered by a reduction in the dose of the secretagogue or insulin.
  • Ozempic® causes a delay of gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications, so caution should be exercised.

Use in Specific Populations

  • There are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Discontinue Ozempic® in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide.

Please click here for Ozempic® Prescribing Information, including Boxed Warning.



References:

  1. Pratley RE, Nauck M, Bailey T, et al; for the 1860-LIRA-DPP-4 Study Group. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet. 2010;375(9724):1447-1456.
  2. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384(9951):1349-1357.
  3. Bailey TS, Takács R, Tinahones FJ, et al. Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes (LIRA-SWITCH™): a randomized, double-blind, double-dummy, active-controlled 26-week trial. Diabetes Obes Metab. 2016; 18(12):1191-1198.
  4. Victoza [package insert]. Plainsboro, NJ: Novo Nordisk Inc; June 2019.
  5. Malm-Erjefält M, Bjørnsdottir I, Vanggaard J. Metabolism and excretion of the once-daily human glucagon-like peptide-1 analog liraglutide in healthy male subjects and its in vitro degradation by dipeptidyl peptidase IV and neutral endopeptidase. Drug Metab Dispos. 2010;38(11):1944-1953.
  6. Davies MJ, Bain SC, Atkin SL, et al. Efficacy and safety of liraglutide versus placebo as add-on to glucose-lowering therapy in patients with type 2 diabetes and moderate renal impairment (LIRA-RENAL): a randomized clinical trial. Diabetes Care. 2016;39(2):222-230.
  7. Tamborlane WV, Barrientos-Perez M, Fainberg U, et al. Liraglutide in children and adolescents with type 2 diabetes. N Engl J Med. 2019;381(7):637-646.