LOS ANGELES, Nov. 4, 2015 /PRNewswire/ -- Today, new data from the phase 3a SCALE™ (Satiety and Clinical Adiposity: Liraglutide Evidence in Non-Diabetic and Diabetic adults) Obesity and Pre-diabetes three-year trial extension were presented at ObesityWeek 2015, the 3rd annual combined congress of the American Society for Metabolic and Bariatric Surgery and The Obesity Society. The extension part of the trial (n=2,254 adults with obesity or who were overweight with comorbidities and had pre-diabetes at baseline), demonstrated that treatment with Saxenda® in combination with a reduced-calorie diet and increased physical activity resulted in significant and sustained weight loss over the three-year span, compared with placebo (reduced-calorie diet and increased physical activity alone).1
At week 160, those randomized to treatment with Saxenda® (n=1,505) achieved an average body weight loss of 6.1% from baseline, compared with 1.9% for placebo treatment (n=749; P<0.0001); 49.6% of adults treated with Saxenda® achieved ≥5% weight loss, compared to 23.7% of adults on placebo (P<0.0001).1,2 In addition, 24.8% lost more than 10% of their body weight when treated with Saxenda® compared to 9.9% with placebo (P<0.0001). Moreover, 52.6% of adults who were treated with Saxenda® completed the 160-week extension trial vs. 45% of those in the placebo group.1
In addition, the extension met its primary end point, demonstrating that ongoing treatment with Saxenda® in combination with reduced-calorie diet and increased physical activity delayed the onset of type 2 diabetes, compared with placebo.1
"Losing and maintaining weight loss can be very challenging for adults with obesity or who are overweight," said Professor Carel le Roux, University College Dublin, Ireland, and SCALE™ clinical trial investigator. "These data are very important as they demonstrated the clinical value of Saxenda® over a period of three years."
Withdrawal rates due to adverse events were 13.3% with Saxenda® (liraglutide [rDNA origin] injection) compared with 6.2% with placebo. Serious adverse events were reported by 15.1% in the Saxenda® group and 12.9% with placebo. The incidence of gallbladder-related and confirmed pancreatitis events were more frequent with Saxenda® (2.9 events per 100 patient years of observation [PYO] and 0.29/100 PYO, respectively) vs. placebo (1.2/100 PYO and 0.13/100 PYO, respectively).1
Indications and Usage
What is Saxenda®?
Saxenda® is an injectable prescription medicine that may help some adults with excess weight (body mass index [BMI] ≥27) who also have weight-related medical problems or obesity (BMI ≥30), lose weight and keep the weight off. Saxenda® should be used with a reduced-calorie meal plan and increased physical activity.
Important Safety Information
What is the most important information I should know about Saxenda®?
Serious side effects may happen in people who take Saxenda®, including:
1. Possible thyroid tumors, including cancer. During the drug testing process, the medicine in Saxenda® caused rats and mice to develop tumors of the thyroid gland. Some of these tumors were cancers. It is not known if Saxenda® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid cancer in people. If medullary thyroid cancer occurs, it may lead to death if not detected and treated early. If you develop tumors or cancer of the thyroid, your thyroid may have to be surgically removed.
2. Inflammation of the pancreas (pancreatitis), which may be severe and lead to death.
Who should not use Saxenda®?
Do not use Saxenda® if:
What should I tell my health care professional before using Saxenda®?
Before taking Saxenda®, tell your health care professional if you:
Tell your health care professional about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Saxenda® slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Saxenda® may affect the way some medicines work and some other medicines may affect the way Saxenda® works. Tell your health care professional if you take diabetes medicines, especially sulfonylurea medicines or insulin.
Know the medicines you take. Keep a list of them with you to show your health care professional and pharmacist each time you get a new medicine.
How should I use Saxenda®?
What are the possible side effects of Saxenda®?
Saxenda® may cause serious side effects, including:
Common side effects of Saxenda® include nausea, diarrhea, constipation, low blood sugar (hypoglycemia), vomiting, headache, decreased appetite, upset stomach, tiredness, dizziness, stomach pain, and changes in enzyme (lipase) levels in your blood. Nausea is most common when first starting Saxenda®, but decreases over time in most people as their body gets used to the medicine. Tell your health care professional if you have any side effect that bothers you or that does not go away.
About obesity
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to health care systems.3,4 In 2011–2012 in the US, approximately 35% of adults, or nearly 79 million adults, live with obesity.5,6
About Saxenda®
Saxenda® is a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake. Like human GLP-1, Saxenda® regulates appetite and lowers body weight through decreased food intake. As with other GLP-1 receptor agonists, liraglutide stimulates insulin secretion and reduces glucagon secretion in a glucose-dependent manner. These effects can lead to a reduction of blood glucose. Saxenda® was evaluated in the SCALE™ (Satiety and Clinical Adiposity−Liraglutide Evidence in Non-diabetic and Diabetic adults) phase 3 clinical trial program.7
Saxenda® was approved by the FDA on December 23, 2014, as an adjunct to a reduced- calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI of ≥30 kg/m2) or who are overweight (BMI of ≥27 kg/m2) in the presence of at least one weight-related comorbid condition (e.g. hypertension, dyslipidemia, type 2 diabetes).2,7
Saxenda® (liraglutide [rDNA origin] injection) was approved by Health Canada on February 26, 2015, and was granted European marketing authorization on March 23, 2015, by the European Commission (EC). It was also approved in Mexico on September 30, 2015.2 Please refer to the local labels for more information.
Guidance is given in all labels that treatment with Saxenda® should be discontinued if a specific threshold of weight loss has not been achieved after a certain period of time.
About SCALE™ Obesity and Pre-diabetes
The SCALE™ Obesity and Pre-diabetes trial is a randomized, double-blind, placebo-controlled, multinational trial in adults without diabetes with obesity and adults without diabetes who are overweight with weight-related comorbidities. There were 3,731 participants randomized to treatment with Saxenda® or placebo in combination with reduced-calorie diet and increased physical activity.7 In addition, participants were further stratified to 56 weeks or 160 weeks of treatment based on pre-diabetes status at baseline screening.2
The objectives of this trial were to demonstrate the safety and efficacy of Saxenda® compared with placebo, as well as to investigate the long-term potential efficacy of Saxenda® to delay the onset of type 2 diabetes in participants with pre-diabetes at baseline screening.2
It is the largest of the phase 3a trials in the SCALE™ clinical development program, which encompassed more than 5,000 adults with obesity or adults who are overweight with weight-related comorbidities.2
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. Headquartered in Denmark, Novo Nordisk employs approximately 39,700 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk-us.com or follow us on Twitter.
Further information
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Katrine Sperling |
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Asa Josefsson |
+45 3079 7708 |
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Sharon Corbitt (US) |
+1 609 578 9974 |
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Investors: |
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Peter Hugreffe Ankersen |
+45 3075 9085 |
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Melanie Raouzeos |
+45 3075 3479 |
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Daniel Bohsen |
+45 3079 6376 |
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Frank Daniel Mersebach (US) |
+1 609 235 8567 |
References
1 Le Roux C, Astrup A, Fujioka K, et al. Reduction in the risk of developing type 2 diabetes (T2D) with liraglutide 3.0 mg in people with prediabetes from the SCALE Obesity and Prediabetes randomized, double-blind, placebo-controlled trial. Poster presented at: The 32nd ASMBS Annual Meeting, the 33rd Annual Scientific Meeting of The Obesity Society, & the 3rd Annual ObesityWeek Event. November 2-6, 2015;Los Angeles, CA. | |
2 Data on file. Novo Nordisk Inc; Plainsboro, NJ. | |
3 World Health Organization. Fact sheet no. 311: obesity and overweight. http://www.who.int/mediacentre/factsheets/fs311/en/. Updated January 2015. Accessed August 11, 2015. | |
4 Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Economics. 2012;31(1):219-230. | |
5 Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014;311(8):806-814. | |
6 Centers for Disease Control and Prevention. Adult obesity facts. http://www.cdc.gov/obesity/data/adult.html. Updated September 21, 2015. Accessed October 26, 2015. | |
7 Saxenda [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2015. |
Saxenda® and Victoza® are registered trademarks and SCALE™ is a trademark of Novo Nordisk A/S. |
Novo Nordisk is a registered trademark of Novo Nordisk A/S. |
© 2015 Novo Nordisk All rights reserved. 1015-00028704-1 November 2015 |
SOURCE Novo Nordisk Inc.