New data in adults with obesity or who are overweight with comorbidities losing at least 5% body weight with Saxenda® showed improvement in blood glucose, CV risk factors and quality of life outcomes
SAN DIEGO, CA, USA I March 8, 2015 I Yesterday, new data from the phase 3a SCALET Obesity and Prediabetes trial were presented at The Endocrine Society’s 97th Annual Meeting (ENDO), showing that adults with obesity or who are overweight with comorbidities who had lost ?5% of their body weight at 56 weeks (ie weight loss responders), demonstrated greater improvements across a range of efficacy outcomes with Saxenda® (liraglutide 3 mg) treatment in combination with a reduced-calorie diet and increased physical activity, compared with those that had a weight loss of
In the SCALET Obesity and Prediabetes trial, 63.2% of adults achieved a clinically meaningful body weight reduction of at least 5% with Saxenda® compared with 27.1% on placebo (p
In addition to weight loss, improvements across a number of secondary endpoints were also observed in the responder population (Saxenda® and placebo). A greater improvement was seen in fasting plasma glucose (FPG) in Saxenda® responders compared with placebo responders (-8.3 vs -2.8 mg/dl, respectively) as well as non-responders (-5.0 vs +1.1 mg/dl, respectively). In addition, treatment with Saxenda® was associated with a greater reduction in systolic blood pressure (SBP) compared with placebo in both responders (-5.5 vs -3.4 mm Hg, respectively) and non-responders (-2.0 vs. -0.8 mm Hg, respectively). Improvements in physical health scores (as measured by the SF-36 questionnaire) were seen with Saxenda® and placebo responders (+4.3 vs +4.1 points, respectively) compared with non-responders (+2.1 vs +1.3 points, respectively).1
“These are important findings as they show that for adults with obesity or who are overweight with comorbidities, losing 5% to 10% of their body weight can help improve comorbidities, including fasting plasma glucose and blood pressure,” said Dr Patrick O’Neil, Professor of Psychiatry and Behavioral Sciences at the Medical University of South Carolina and SCALET clinical trial investigator. “Those who responded, losing 5% or more of their body weight, not only saw improvements in cardiometabolic risk factors but also in quality of life outcomes, compared with those who did not respond, for both liraglutide and placebo treatment.”
Across the SCALET clinical development programme, Saxenda® (liraglutide 3 mg) was generally well tolerated. The most common side effects observed were related to the gastrointestinal system. In the SCALET Obesity and Prediabetes trial, rates of adverse events were similar in both responders and non-responders. The number of adverse events leading to trial withdrawal was lower in responders compared with non-responders.1
About obesity
Obesity is a disease that requires chronic management. – It is associated with serious comorbidities including type 2 diabetes, heart disease, obstructive sleep apnoea (OSA), certain types of cancer and a decreased life expectancy. – The risk of morbidity and mortality increases with the severity of obesity.8, It is a complex and multifactorial disease that is influenced by genetic, physiological, environmental and psychological factors.
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. , In 2011-2012 in the US, approximately 35% of adults, or nearly 80 million adults, live with obesity.
About Saxenda®
Saxenda® is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake.2 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 SCALET (Satiety and Clinical Adiposity?Liraglutide Evidence in Nondiabetic and Diabetic people) phase 3 clinical trial programme, which involved more than 5,000 study participants who have obesity (BMI ?30 kg/m2) or who are overweight (BMI ?27 kg/m2) with comorbidities.2
Saxenda® was approved by the FDA on 23 December 2014, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI ?30 kg/m2) or who are overweight (BMI ?27 kg/m2) with at least one weight-related comorbidity.
Saxenda® received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 22 January 2015. In accordance with the EMA Centralised Procedure, a decision whether to grant marketing authorisation is taken by the European Commission within approximately 2 to 3 months.14
About SCALET Obesity and Prediabetes
The SCALET Obesity and Prediabetes trial is a randomised, double-blind, placebo-controlled, multinational trial in non-diabetic adults with obesity and non-diabetic adults who are overweight with comorbidities. There were 3,731 participants randomised to treatment with Saxenda® (liraglutide 3 mg) or placebo in combination with reduced-calorie diet and increased physical activity.2 In addition, participants were further stratified to 56 weeks or 160 weeks of treatment based on prediabetes status at baseline screening.14
The objectives of this trial were to demonstrate clinically meaningful weight loss at 56 weeks, as well as to investigate the long-term potential efficacy of Saxenda® to delay the onset of type 2 diabetes in participants with prediabetes at baseline screening.
It is the largest of the phase 3a trials in the SCALET clinical development programme, which encompassed more than 5,000 adults with obesity or adults who are overweight with comorbidities.14
About Novo Nordisk
Headquartered in Denmark, Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Novo Nordisk employs approximately 41,500 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
Novo Nordisk is a healthcare company and a world leader in diabetes care.
In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society.
SOURCE: Novo Nordisk
Post Views: 124
New data in adults with obesity or who are overweight with comorbidities losing at least 5% body weight with Saxenda® showed improvement in blood glucose, CV risk factors and quality of life outcomes
SAN DIEGO, CA, USA I March 8, 2015 I Yesterday, new data from the phase 3a SCALET Obesity and Prediabetes trial were presented at The Endocrine Society’s 97th Annual Meeting (ENDO), showing that adults with obesity or who are overweight with comorbidities who had lost ?5% of their body weight at 56 weeks (ie weight loss responders), demonstrated greater improvements across a range of efficacy outcomes with Saxenda® (liraglutide 3 mg) treatment in combination with a reduced-calorie diet and increased physical activity, compared with those that had a weight loss of
In the SCALET Obesity and Prediabetes trial, 63.2% of adults achieved a clinically meaningful body weight reduction of at least 5% with Saxenda® compared with 27.1% on placebo (p
In addition to weight loss, improvements across a number of secondary endpoints were also observed in the responder population (Saxenda® and placebo). A greater improvement was seen in fasting plasma glucose (FPG) in Saxenda® responders compared with placebo responders (-8.3 vs -2.8 mg/dl, respectively) as well as non-responders (-5.0 vs +1.1 mg/dl, respectively). In addition, treatment with Saxenda® was associated with a greater reduction in systolic blood pressure (SBP) compared with placebo in both responders (-5.5 vs -3.4 mm Hg, respectively) and non-responders (-2.0 vs. -0.8 mm Hg, respectively). Improvements in physical health scores (as measured by the SF-36 questionnaire) were seen with Saxenda® and placebo responders (+4.3 vs +4.1 points, respectively) compared with non-responders (+2.1 vs +1.3 points, respectively).1
“These are important findings as they show that for adults with obesity or who are overweight with comorbidities, losing 5% to 10% of their body weight can help improve comorbidities, including fasting plasma glucose and blood pressure,” said Dr Patrick O’Neil, Professor of Psychiatry and Behavioral Sciences at the Medical University of South Carolina and SCALET clinical trial investigator. “Those who responded, losing 5% or more of their body weight, not only saw improvements in cardiometabolic risk factors but also in quality of life outcomes, compared with those who did not respond, for both liraglutide and placebo treatment.”
Across the SCALET clinical development programme, Saxenda® (liraglutide 3 mg) was generally well tolerated. The most common side effects observed were related to the gastrointestinal system. In the SCALET Obesity and Prediabetes trial, rates of adverse events were similar in both responders and non-responders. The number of adverse events leading to trial withdrawal was lower in responders compared with non-responders.1
About obesity
Obesity is a disease that requires chronic management. – It is associated with serious comorbidities including type 2 diabetes, heart disease, obstructive sleep apnoea (OSA), certain types of cancer and a decreased life expectancy. – The risk of morbidity and mortality increases with the severity of obesity.8, It is a complex and multifactorial disease that is influenced by genetic, physiological, environmental and psychological factors.
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. , In 2011-2012 in the US, approximately 35% of adults, or nearly 80 million adults, live with obesity.
About Saxenda®
Saxenda® is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake.2 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 SCALET (Satiety and Clinical Adiposity?Liraglutide Evidence in Nondiabetic and Diabetic people) phase 3 clinical trial programme, which involved more than 5,000 study participants who have obesity (BMI ?30 kg/m2) or who are overweight (BMI ?27 kg/m2) with comorbidities.2
Saxenda® was approved by the FDA on 23 December 2014, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI ?30 kg/m2) or who are overweight (BMI ?27 kg/m2) with at least one weight-related comorbidity.
Saxenda® received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 22 January 2015. In accordance with the EMA Centralised Procedure, a decision whether to grant marketing authorisation is taken by the European Commission within approximately 2 to 3 months.14
About SCALET Obesity and Prediabetes
The SCALET Obesity and Prediabetes trial is a randomised, double-blind, placebo-controlled, multinational trial in non-diabetic adults with obesity and non-diabetic adults who are overweight with comorbidities. There were 3,731 participants randomised to treatment with Saxenda® (liraglutide 3 mg) or placebo in combination with reduced-calorie diet and increased physical activity.2 In addition, participants were further stratified to 56 weeks or 160 weeks of treatment based on prediabetes status at baseline screening.14
The objectives of this trial were to demonstrate clinically meaningful weight loss at 56 weeks, as well as to investigate the long-term potential efficacy of Saxenda® to delay the onset of type 2 diabetes in participants with prediabetes at baseline screening.
It is the largest of the phase 3a trials in the SCALET clinical development programme, which encompassed more than 5,000 adults with obesity or adults who are overweight with comorbidities.14
About Novo Nordisk
Headquartered in Denmark, Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Novo Nordisk employs approximately 41,500 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
Novo Nordisk is a healthcare company and a world leader in diabetes care.
In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society.
SOURCE: Novo Nordisk
Post Views: 124
