BOSTON, April 4, 2016 /PRNewswire/ -- Today, new data from the three-year part of the phase 3a SCALE™ (Satiety and Clinical Adiposity – Liraglutide Evidence) Obesity and Pre-diabetes trial were presented at the Endocrine Society's 98th Annual Meeting and Expo (ENDO 2016). The three-year part of the trial (n=2,254 adults with obesity or who were overweight with comorbidities and had pre-diabetes at baseline) data demonstrated that 160 weeks of treatment with Saxenda® (n=1,505) in combination with a reduced-calorie diet and increased physical activity resulted in significant improvements in cardiometabolic risk factors (such as blood pressure and cholesterol) compared with placebo (reduced-calorie diet and increased physical activity alone) (n=749).1
At week 160, individuals treated with Saxenda® had lost more weight (6.1%) than those treated with placebo (1.9%) (estimated treatment difference [ETD] -4.3% [95% CI, -4.9; -3.7], P<0.0001).1 In addition, treatment with Saxenda® achieved results beyond weight loss, including improvements in some cardiometabolic risk factors such as blood pressure and cholesterol. At week 160, participants randomized to treatment with Saxenda® experienced a greater reduction in systolic blood pressure compared with placebo (ETD -2.8 mmHg [-3.8; -1.8], P<0.0001). Those treated with Saxenda® also experienced greater improvements in triglycerides (ETD -6% [-9; -3], P=0.0003) and total cholesterol levels (ETD -2% [-3; 0], P=0.03) compared with placebo. Additionally, people treated with Saxenda® showed a greater reduction in mean waist circumference (ETD -3.5 cm/-1.4 in [-4.2 cm/-1.7 in; -2.8 cm/-1.1 in]).
"We know that weight loss of as little as 5% to 10% in people with obesity can have an impact on cardiometabolic risk factors," said Dr. Ken Fujioka, Scripps Clinic, San Diego, California, and a SCALE™ clinical trial investigator. "This is currently the longest weight-management trial with Saxenda® (liraglutide [rDNA origin] injection), and the observed improvements in blood pressure, lipids, and waist circumference at three years are encouraging."
In addition, the three-year part of the SCALE™ Obesity and Pre-diabetes trial met its primary endpoint, demonstrating that continued treatment over three years with Saxenda®, in combination with a reduced-calorie diet and increased physical activity, delayed the onset of type 2 diabetes compared with placebo.1
Aligned with previous trials, during treatment with Saxenda®, mean pulse rate was increased (ETD +2 beats/min [+1.2; +2.7], P<0.0001).1 Saxenda® was generally well tolerated, and observed side effects were in line with previous trials. Over 160 weeks, reports of serious adverse events were higher in those treated with Saxenda® compared with placebo (15.1% vs 12.9%). Rates of gallbladder-related adverse events and confirmed acute pancreatitis were more frequent in those treated 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). The frequency of adjudicated major adverse cardiovascular events was low, and comparable in those treated with Saxenda® and placebo (0.19 vs 0.20 events/100 PYO).1
About SCALE™ Obesity and Pre-diabetes
SCALE™ is a randomized, double-blind, placebo-controlled, multinational trial in adults without diabetes who have 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 a reduced-calorie diet and increased physical activity.2 Participants were further stratified to 56 weeks or 160 weeks of treatment based on pre-diabetes status at baseline screening.3
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.3
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.3
Indications and Usage
What is Saxenda® (liraglutide [rDNA origin] injection)?
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.
Please click here for Prescribing Information.
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.2
Saxenda® (liraglutide [rDNA origin] injection) 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).2,3
As of February 2016, Saxenda® injection has been commercially launched in the United States, Canada, and Denmark. It has also been approved in the European Union, Mexico, and Australia. Please refer to local labels for more information.
About obesity
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to health care systems.4,5 In 2011–2012 in the United States, approximately 35% of adults, or nearly 79 million adults, lived with obesity.6,7
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 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.
Please see Important Safety Information throughout.
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References
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© 2016 Novo Nordisk All rights reserved. USA16SAM00693 April 2016
SOURCE Novo Nordisk Inc.