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B Hunt, M Mocarski, W J Valentine, J Langer
BACKGROUND AND AIMS: IDegLira, a fixed ratio combination of insulin degludec and glucagon-like peptide-1 receptor agonist liraglutide, utilizes the complementary mechanisms of action of these two agents to improve glycemic control with low risk of hypoglycemia and avoidance of weight gain. The aim of the present analysis was to assess the long-term cost-effectiveness of IDegLira vs liraglutide added to basal insulin, for patients with type 2 diabetes not achieving glycemic control on basal insulin in the US setting...
March 3, 2017: Journal of Medical Economics
Allen B King, Athena Philis-Tsimikas, Eric S Kilpatrick, Irene H Langbakke, Kamilla Begtrup, Tina Vilsbøll
BACKGROUND: Reducing glycemic fluctuation is important for optimal diabetes management. This post hoc analysis examined glycemic fluctuations and the proportion of subjects achieving recommended blood glucose targets with the fixed ratio combination of insulin degludec and liraglutide (IDegLira) compared to insulin degludec (IDeg) and liraglutide alone. METHODS: We analyzed nine-point self-monitored blood glucose (SMBG) profiles from two randomized trials involving IDegLira in patients with type 2 diabetes (T2D), and continuous glucose monitoring (CGM) data from a subset of patients in one of these trials to assess glycemic fluctuation and day-to-day variability...
March 10, 2017: Diabetes Technology & Therapeutics
Barnaby Hunt, Michelle Mocarski, William J Valentine, Jakob Langer
INTRODUCTION: Effective glycemic control can reduce the risk of complications and their related costs in type 2 diabetes mellitus (T2DM). However, many patients fail to reach glycemic targets, often because of adverse effects of treatment (including hypoglycemia or weight gain). The present analysis evaluated the short-term cost-effectiveness of IDegLira versus continued up-titration of insulin glargine U100 in patients with T2DM failing to achieve glycemic control on basal insulin in the US setting...
March 9, 2017: Advances in Therapy
Daniela Sofra
INTRODUCTION: The aim of the present study was to describe clinical outcomes in a real-world population of Swiss patients with long-standing, poorly controlled type 2 diabetes after switching to IDegLira [a combination of insulin degludec (IDeg) and liraglutide (Lira)]. METHODS: This was a prospective, open-label, single-center observational follow-up at the Cabinet Medical de Diabétologie, Lausanne, Switzerland, of 61 patients [HbA1c 9.2% (77 mmol/mol) and 56...
February 20, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Louise Vedtofte, Filip K Knop, Tina Vilsbøll
Type 2 diabetes (T2D) is a progressive disease with increasing prevalence in most countries. The majority of patients with T2D have inadequate glycaemic control, which increases the risk of diabetic complications later in life. New therapies with improved safety profiles are required to tackle the progressive nature of T2D. Areas covered: The efficacy and safety profile of IDegLira - a once-daily, fixed-ratio combination of insulin degludec and liraglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), for the treatment of T2D - has been extensively evaluated...
March 2017: Expert Opinion on Drug Safety
Stewart B Harris, Győző Kocsis, Rudolf Prager, Terry Ridge, Keval Chandarana, Natalie Halladin, Serge Jabbour
OBJECTIVE: To compare the safety and efficacy of a simpler titration algorithm for insulin degludec/liraglutide (IDegLira) with that used in previous DUAL trials in insulin-naïve patients with type 2 diabetes. RESEARCH DESIGN AND METHODS This 32-week, open-label, non-inferiority trial randomized adults with type 2 diabetes uncontrolled on metformin ± pioglitazone to receive IDegLira, titrated either once weekly based on the mean of two pre-breakfast plasma glucose (PG) readings (n = 210), or twice weekly based on the mean of three pre-breakfast PG readings (n = 210)...
January 26, 2017: Diabetes, Obesity & Metabolism
Åsa Ericsson, Adam Lundqvist
BACKGROUND: Patients with uncontrolled type 2 diabetes mellitus (T2DM) are a priority group for intensified therapy without weight gain and with low risk of hypoglycaemia. OBJECTIVE: This study evaluates the cost effectiveness of insulin degludec plus liraglutide (IDegLira, Xultophy(®)) compared with six potential intensification treatment options for patients with T2DM that is uncontrolled with basal insulin. METHODS: The Swedish Institute for Health Economics (IHE) Cohort Model of Type 2 Diabetes was used with Swedish input data, a 40-year time frame and a societal perspective...
April 2017: Applied Health Economics and Health Policy
M Psota, N Racekova, M Psenkova, T Vandebrouck, A Ramirez de Arellano
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Sultan Linjawi, Bruce W Bode, Louis B Chaykin, Jean-Pierre Courrèges, Yehuda Handelsman, Lucine M Lehmann, Abhishek Mishra, Richard W Simpson
INTRODUCTION: The progressive nature of type 2 diabetes necessitates treatment intensification. This often involves intensification with oral antidiabetic drugs (OADs) initially, followed by other agents, such as glucagon-like peptide-1 receptor agonists (GLP-1RAs), with the majority of patients eventually requiring insulin therapy. Therefore, this trial aimed to investigate the efficacy of IDegLira (combination of insulin degludec and liraglutide) in controlling glycemia in adults with type 2 diabetes who were inadequately controlled on a GLP-1RA and OADs...
February 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
H W Rodbard, B W Bode, S B Harris, L Rose, L Lehmann, H Jarlov, J Thurman
AIM: To investigate the safety and efficacy of insulin degludec/liraglutide (IDegLira), a novel combination product, as add-on therapy for people with Type 2 diabetes uncontrolled on sulphonylurea therapy. METHODS: In this 26-week, double-blind trial, adults with Type 2 diabetes [HbA1c 53-75 mmol/mol (7.0-9.0%)] were randomized to IDegLira (n = 289) or placebo (n = 146) as add-on to pre-trial sulphonylurea ± metformin, titrating to a fasting glycaemic target of 4...
February 2017: Diabetic Medicine: a Journal of the British Diabetic Association
Elizabeth Mary Lamos, Stephen N Davis
INTRODUCTION: Type 2 diabetes is a complex disease requiring individualized and often multi-faceted treatment plans. Balancing glycemic control with adverse medication side effects can be challenging. Combination therapy of basal insulin and GLP-1 receptor agonist therapy appears to provide a balance between glycemic efficacy, hypoglycemia and weight gain. AREAS COVERED: Available pharmacokinetic data, clinical trials and abstracts regarding fixed-ratio combination of insulin degludec and liraglutide were reviewed...
October 2016: Expert Opinion on Drug Metabolism & Toxicology
Melanie J Davies, Divina Glah, Barrie Chubb, Gerasimos Konidaris, Phil McEwan
OBJECTIVES: Once-daily insulin degludec/liraglutide (IDegLira) is the first basal insulin and glucagon like peptide-1 receptor agonist combined in one delivery device. Our aim was to investigate the cost effectiveness of IDegLira vs. basal insulin intensification therapies for patients with type 2 diabetes mellitus uncontrolled on basal insulin (glycosylated haemoglobin; HbA1c >7.5 %; 58 mmol/mol) in a UK setting. RESEARCH DESIGN AND METHODS: Baseline cohort and clinical parameters were sourced from a pooled analysis comparing IDegLira with basal insulin plus liraglutide and basal-bolus therapy, and from the DUAL™ V trial comparing IDegLira with up-titrated insulin glargine (IGlar; Lantus(®))...
September 2016: PharmacoEconomics
Stephen Cl Gough, Rajeev Jain, Vincent C Woo
The progressive nature of type 2 diabetes necessitates that treatment is intensified as the disease advances. Several studies have shown that basal insulin and glucagon-like peptide-1 receptor agonists (GLP-1RAs) can be used in combination to successfully improve glycemic control and this combination is increasingly being considered as an alternative to intensification with prandial insulin. Insulin degludec/liraglutide (IDegLira) is the first fixed-ratio combination of a basal insulin and a GLP-1RA in a single formulation...
January 2, 2016: Expert Review of Endocrinology & Metabolism
Tina Vilsbøll, Jiten Vora, Henrik Jarlov, Kajsa Kvist, Lawrence Blonde
BACKGROUND AND OBJECTIVES: The time-course when changes in glycemic control and body weight were first manifest in patients with type 2 diabetes mellitus (T2DM) treated with a combination of insulin degludec and liraglutide (IDegLira) was assessed, comparing IDegLira to its individual components. METHODS: Data from weeks 0-12 from two studies were analyzed, one comparing IDegLira to each component (DUAL I), and one comparing IDegLira to insulin degludec titrated to a maximum 50 units (DUAL II)...
April 2016: Clinical Drug Investigation
Eugene Hughes
In type 2 diabetes (T2D), treatment is optimised to minimise hyperglycaemia and the risk of microvascular complications. While there are a number of effective treatments, intensive treatment is associated with negative side effects such as increased hypoglycaemia and weight gain. With complementary modes of action, glucagon-like peptide-1 receptor agonists (GLP-1RAs) and a basal insulin in combination offer an alternative to basal-bolus therapy in T2D. This review describes the rationale behind this treatment combination and presents clinical data available for IDegLira, the first basal insulin (insulin degludec) and GLP-1RA (liraglutide) co-formulation available in one pen for a single injection daily...
June 2016: Primary Care Diabetes
Nick Freemantle, Muhammad Mamdani, Tina Vilsbøll, Jens Harald Kongsø, Kajsa Kvist, Stephen C Bain
INTRODUCTION: IDegLira is a once-daily combination of insulin degludec (IDeg) and liraglutide. Trials directly comparing IDegLira with alternative strategies for intensifying basal insulin are ongoing. While awaiting results, this analysis compared indirectly how different strategies affected glycated hemoglobin (HbA1c) and other outcomes. METHODS: A pooled analysis of five completed Novo Nordisk randomized clinical trials in patients with type 2 diabetes inadequately controlled on basal insulin was used to compare indirectly IDegLira (N = 199) with: addition of liraglutide to basal insulin (N = 225) [glucagon-like peptide-1 receptor agonist (GLP-1RA) add-on strategy]; basal-bolus (BB) insulin [insulin glargine (IGlar) + insulin aspart] (N = 56); or up-titration of IGlar (N = 329)...
December 2015: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
N Freemantle, I Lingvay, J H Kongsø, T J Abrahamsen, J B Bjorner
No abstract text is available yet for this article.
November 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Jens J Holst, John B Buse, Helena W Rodbard, Sultan Linjawi, Vincent C Woo, Trine Welløv Boesgaard, Kajsa Kvist, Stephen C Gough
OBJECTIVE: IDegLira is a novel, fixed-ratio combination of the long-acting basal insulin, insulin degludec, and the long-acting glucagon-like peptide-1 analog liraglutide. We studied the effect of IDegLira versus its components on postprandial glucose (PPG) in type 2 diabetes. METHODS: In this substudy, 260 (15.6%) of the original 1663 patients with inadequate glycemic control participating in a 26-week, open-label trial (DUAL I) were randomized 2:1:1 to once-daily IDegLira, insulin degludec or liraglutide...
October 6, 2015: Journal of Diabetes Science and Technology
H W Rodbard, J B Buse, V Woo, T Vilsbøll, I H Langbakke, K Kvist, S C L Gough
AIM: To evaluate, using post hoc analyses, whether the novel combination of a basal insulin, insulin degludec, and a glucagon-like peptide-1 receptor agonist, liraglutide (IDegLira), was consistently effective in patients with type 2 diabetes (T2D), regardless of the stage of T2D progression. METHODS: Using data from the DUAL I extension [insulin-naïve patients uncontrolled on oral antidiabetic drugs (OADs), n = 1660, 52 weeks] and DUAL II (patients uncontrolled on basal insulin plus OADs, n = 398, 26 weeks) randomized trials, the efficacy of IDegLira was investigated with regard to measures of disease progression stage including baseline glycated haemoglobin (HbA1c), disease duration and previous insulin dose...
January 2016: Diabetes, Obesity & Metabolism
Christoph Kapitza, Bruce Bode, Steen Hvass Ingwersen, Lisbeth Vestergård Jacobsen, Pernille Poulsen
Insulin degludec/liraglutide (IDegLira) is a novel fixed-ratio combination of the basal insulin insulin degludec (IDeg) and liraglutide, a glucagon-like peptide-1 analog. The pharmacokinetics (PK) and pharmacodynamics of IDegLira were assessed versus its components. A single-dose, randomized, 4-period crossover clinical pharmacology study in healthy subjects compared the bioavailability of IDegLira with its monocomponents. Dose proportionality, covariate effects on exposure, and exposure-response for change in glycated hemoglobin were analyzed based on data from a randomized treat-to-target phase 3 study in subjects with type 2 diabetes...
December 2015: Journal of Clinical Pharmacology
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