Novo Nordisk A/S Release: Victoza (liraglutide [rDNA origin] injection) Provided Superior Hba1c Reductions In Adults With Type 2 Diabetes Compared To Continued Sitagliptin Treatment
BOSTON, April 2, 2016 /PRNewswire/ -- Findings from a clinical trial comparing Victoza® (liraglutide [rDNA origin] injection) and sitagliptin (100 mg), both in combination with metformin, demonstrated that switching from sitagliptin to Victoza® provided superior HbA1c reductions vs continuing with sitagliptin treatment in adults with type 2 diabetes. Results from the LIRA-SWITCH trial were presented at the Endocrine Society's 98th Annual Meeting and Expo (ENDO 2016) in Boston, Massachusetts.1
The 26-week LIRA-SWITCH trial assessed the efficacy and safety of Victoza® as an add-on to metformin in 407 adults with type 2 diabetes who switched from sitagliptin.1 Of the 407 adults uncontrolled on sitagliptin (HbA1c 7.59.5%) at week 26, those who switched to Victoza® (n=203) achieved a superior reduction in HbA1c vs those who continued their sitagliptin treatment (n=204) (1.14% vs 0.54%; estimated treatment difference [ETD] 0.61%, 95% confidence interval [CI]: 0.82 to 0.40, P<0.0001).1
Additionally, adults who switched to Victoza® experienced significantly greater body weight reductions vs those who continued with their sitagliptin dose (3.31 kg/7.29 lb vs 1.64 kg/3.62 lb; ETD 1.67 kg/3.68 lb, 95% CI: 2.34 to 0.99, P<0.0001).1
"The LIRA-SWITCH trial results provide valuable insight that adults uncontrolled on sitagliptin may achieve a superior reduction with liraglutide 1.8 mg vs continuing on sitagliptin treatment," said Dr Maximo Maislos, Atherosclerosis and Metabolism Unit, Soroka UMC, Ben-Gurion University FOHS, Beer Sheva-Israel, and investigator of the LIRA-SWITCH trial. "These findings are valuable as there is limited clinical evidence to guide treatment strategy when people with type 2 diabetes are uncontrolled on second-line therapy."
The trial demonstrated that more adults with type 2 diabetes treated with Victoza® vs sitagliptin achieved HbA1c targets <7% (50.6% vs 26.9% OR: 3.36 95%; CI: 2.08 to 5.42 P<0.0001) and 6.5% (29.5% vs 9.9%; OR: 5.44; 95% CI: 2.82 to 10.47, P<0.0001 for both).1 Furthermore, adults treated with Victoza® demonstrated significantly greater reductions in fasting plasma glucose vs those treated with sitagliptin (33.09 mg/dL vs 13.19 mg/dL; P<0.0001)1
Adverse events were more common in the Victoza® group vs the sitagliptin group (68.8% vs. 56.9%), with gastrointestinal side effects more frequent with Victoza®: nausea (21.8% vs 7.8%) and diarrhea (16.3% vs 9.3%).1 There were no reports of severe hypoglycemia and no reports of confirmed nocturnal hypoglycemia in either treatment arm.1
About the LIRA-SWITCH Trial
The 26-week trial was a randomized, double-blind, double-dummy, active-controlled trial involving 407 adults with type 2 diabetes not achieving adequate glycemic control on sitagliptin as add-on to metformin.1 Trial participants were previously treated with stable doses of sitagliptin (100 mg daily) and metformin (1500 mg daily or maximum tolerated dose 1000 mg daily) for 90 days.1 Participants were randomized 1:1 to switch to Victoza® 1.8 mg or continue sitagliptin 100 mg, both in combination with metformin.1
Indications and Usage
What is Victoza® (liraglutide [rDNA origin] injection)?
Victoza® is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes, and should be used along with diet and exercise.
- Victoza® is not recommended as the first choice of medicine for treating diabetes.
- It is not known if Victoza® can be used in people who have had pancreatitis.
- Victoza® is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
- It is not known if Victoza® can be used with mealtime insulin.
- It is not known if Victoza® is safe and effective for use in children.
Important Safety Information
What is the most important information I should know about Victoza®?
Victoza® may cause serious side effects, including:
- Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, Victoza® and medicines that work like Victoza® caused thyroid tumors, including thyroid cancer. It is not known if Victoza® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Please see additional Important Safety Information on next page.
Who should not use Victoza® (liraglutide [rDNA origin] injection)?
Do not use Victoza® if:
- you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- you are allergic to liraglutide or any of the ingredients in Victoza®.
What should I tell my health care provider before using Victoza®?
Before using Victoza®, tell your health care provider if you:
- have or have had problems with your pancreas, kidneys, or liver.
- have any other medical conditions or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
- are pregnant or breastfeeding or plan to become pregnant or breastfeed.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.
How should I use Victoza®?
- Do not mix insulin and Victoza® together in the same injection.
- You may give an injection of Victoza® and insulin in the same body area (such as your stomach area), but not right next to each other.
- Do not share your Victoza® pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
What are the possible side effects of Victoza®?
Victoza® may cause serious side effects, including:
- inflammation of your pancreas(pancreatitis). Stop using Victoza® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
- low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Victoza® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.
- kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse.
- seriousallergic reactions. Stop using Victoza® and get medical help right away if you have any symptoms of a serious allergic reaction including itching, rash, or difficulty breathing.
The most common side effects of Victoza® may include headache, nausea, diarrhea, vomiting, and anti-liraglutide antibodies in your blood.
Please [click here for/see accompanying] Prescribing Information.
About Victoza® (liraglutide [rDNA origin] injection)
Victoza® is a human glucagon-like peptide-1 (GLP-1) analog that was approved by the U.S. Food and Drug Administration on January 25, 2010, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
As of March 2015, Victoza® has been commercially launched in 75 countries, including the United States, Canada, Japan, United Kingdom, Germany, France, Italy, Denmark, Hungary, Russia, India, Brazil, Mexico, Argentina, Malaysia and China.
About Diabetes
In the United States, more than 29 million people are affected by diabetes.2 Type 2 diabetes accounts for 90 to 95 percent of all diabetes cases.3 Diabetes is emerging as one of the most serious health problems of our time; the number of Americans with diabetes has almost quadrupled over the past 30 years.3
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people with other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has more than 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.
References
- Bailey T, Takács R, Tinahones F, et al. Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes: a randomized, double-blind, double-dummy, active-controlled 26-week trial. Abstract number 689. Endocrine Society's 98th Annual Meeting (ENDO), Boston, MA, USA; April 1-4 2016.
- Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2014. http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf. Accessed January 19, 2016.
- Centers for Disease Control and Prevention. Number (in Millions) of Civilian, Noninstitutionalized Adults with Diagnosed Diabetes, United States, 19802014. http://www.cdc.gov/diabetes/statistics/prev/national/figpersons.htm. Accessed January 19, 2016.
Victoza® is a registered trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2016 Novo Nordisk All rights reserved. USA16VIM01753 April 2016
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