Dasiglucagon demonstrates reduced costs in the treatment of severe hypoglycemia in a budget impact model.

Approximately 7.3 million people with type 1 or type 2 diabetes (T1D/T2D) are treated with insulin, placing them at higher risk of severe hypoglycemia (SH). SH requires assistance of another individual and often necessitates the prompt administration of intravenous glucose, injectable glucagon, or both.

Congenital hyperinsulinism in infancy and childhood: challenges, unmet needs and the perspective of patients and families.

Background: Congenital hyperinsulinism (CHI) is the most common cause of persistent hypoglycemia in infants and children, and carries a considerable risk of neurological damage and developmental delays if diagnosis and treatment are delayed. Despite rapid advances in diagnosis and management, long-term developmental outcomes have not significantly improved in the past years. CHI remains a disease that is associated with significant morbidity, and psychosocial and financial burden for affected families, especially concerning the need for constant blood glucose monitoring throughout patients' lives.

A Comparative Study of Dasiglucagon Ready-to-Use Autoinjector and Glucagon Emergency Kit During Rescue from Simulated Severe Hypoglycemia.

Severe hypoglycemic episodes are life-threatening events demanding rapid administration of glucagon by a caregiver or bystander. The glucagon analog dasiglucagon is stable in aqueous formulation and therefore suitable for delivery in a ready-to-use autoinjector, potentially increasing speed and ease of use compared with standard glucagon emergency kits (GEKs). In an open label, randomized, crossover, comparative device handling study, trained caregivers and untrained bystanders administered the dasiglucagon autoinjector or Eli Lilly GEK to manikins in a simulated emergency hypoglycemia situation.

Strengthening pharma's contract with society: the value of trusted partnerships between pharma and healthcare facilitated by real-world data.

This White Paper is authored by 11 industry real-world evidence (RWE) experts, with support from IQVIA, as part of the 'RWE Leadership Forum': a group of industry leaders who come together as noncompetitive partners to understand and respond to internal or external RWD/E challenges and opportunities with a single expert voice. Herein we aim to clarify the rules of engagement between pharma and healthcare in order to establish trust-based partnerships, which will unlock unique value for society, including the medical community and the ultimate beneficiary, the patient.

Association of obesity with healthcare resource utilization and costs in a commercial population.

Objective: To examine the association of obesity with healthcare resource utilization (HRU) and costs among commercially insured individuals.

Methods: This retrospective observational cohort study used administrative claims from 1 January 2007 to 1 December 2013. The ICD-9-CM status codes (V85 hierarchy) from 2008 to 2012 classified body mass index (BMI) into the World Health Organizations' BMI categories.

Association of obesity with healthcare utilization and costs in a Medicare population.

Objectives: To examine the association of obesity with healthcare resource utilization and costs in a Medicare population.

Methods: This study was a retrospective cohort study using Humana Medicare Advantage (MA) claims data. Body mass index (BMI) was assessed using ICD-9-CM status codes (V85 hierarchy) that have been validated in the data source to classify patients into BMI categories: normal (N), overweight (Ow), obese class I (ObI), obese class II (ObII), and obese class III (ObIII).

Predictors of glycemic control and diabetes-related costs among type 2 diabetes patients initiating therapy with liraglutide in the United States.

Objective: Liraglutide has been shown to significantly improve glycemic control and reduce body weight while minimizing the risk of hypoglycemia in adult patients with type 2 diabetes (T2D). This study aimed to identify characteristics that predict clinical and economic outcomes associated with liraglutide therapy in clinical practice in the US.

Methods: Using the Truven Health MarketScan Laboratory Database, glycemic control (A1C <7%) and diabetes-related costs were evaluated in T2D patients initiating liraglutide between January 1, 2010 and June 30, 2012.

The Association Between Body Mass Index and Health and Economic Outcomes in the United States.

Objective: The objective of this study is to provide current estimates of the association between obesity and health outcomes and to examine these associations among subgroups of interest (pre-diabetes, type 2 diabetes [T2D], and neither pre-diabetes nor T2D) in the United States.

Methods: Data were analyzed from the 2013 US National Health and Wellness Survey (N = 71,530). Respondents were categorized by body mass index (BMI) class (normal, overweight, obese class I, obese class II, obese class III).

Reporting error in weight and its implications for bias in economic models.

Most research on the economic consequences of obesity uses data on self-reported weight, which contains reporting error that has the potential to bias coefficient estimates in economic models. The purpose of this paper is to measure the extent and characteristics of reporting error in weight, and to examine its impact on regression coefficients in models of the healthcare consequences of obesity. We analyze data from the National Health and Nutrition Examination Survey (NHANES) for 2003-2010, which includes both self-reports and measurements of weight and height.

Prevalence and healthcare costs of obesity-related comorbidities: evidence from an electronic medical records system in the United States.

Objective: This study estimated the economic burden of obesity-related comorbidities (ORCs) in the US, at both the person and population levels.

Methods: The Geisinger Health System provided electronic medical records and claims between January 2004 and May 2013 for a sample of 153,561 adults (50% males and 97% white). Adults with < 2 years of data, who were underweight (body mass index (BMI) < 18.

Impact of medication adherence and persistence on clinical and economic outcomes in patients with type 2 diabetes treated with liraglutide: a retrospective cohort study.

Introduction: Adherence to diabetes medication has been linked to improved glycemic levels and lower costs, but previous research on adherence has typically involved oral antidiabetic medication or insulin. This study examines how adherence and persistence to once-daily liraglutide impact glycemic control and economic outcomes in a real-world population of adult type 2 diabetes (T2D) patients.

Methods: A retrospective cohort study using administrative claims data from July 2009 through September 2013.

The Economic Burden of Obesity by Glycemic Stage in the United States.

Background: Electronic medical records and insurance claims data from the Geisinger Health System were examined to assess the real-world healthcare costs of being overweight or obese at different glycemic stages, including normal glycemia, pre-diabetes (PreD), and type 2 diabetes (T2D).

Methods: The medical history of the sample subjects was segmented into different glycemic stages via diagnosis codes, glycosylated hemoglobin A1c or fasting plasma glucose laboratory results, and use of antidiabetic drugs. Healthcare resource utilization captured by the claims and associated costs (in 2013 values) were examined for each glycemic stage.

Savings in Medical Expenditures Associated with Reductions in Body Mass Index Among US Adults with Obesity, by Diabetes Status.

Background: The prevalence of obesity has more than doubled in the USA in the past 30 years. Obesity is a significant risk factor for diabetes, cardiovascular disease, and other clinically significant co-morbidities. This paper estimates the medical care cost savings that can be achieved from a given amount of weight loss by people with different starting values of body mass index (BMI), for those with and without diabetes.

Variation in the risk of progression between glycemic stages across different levels of body mass index: evidence from a United States electronic health records system.

Objective: The purpose of this study was to assess how the risks of glycemic stage transitions observed in clinical practice vary with body mass index (BMI). These transitions included progression from euglycemia ('normal') to prediabetes (PreD) and from PreD to type 2 diabetes (T2D), as well as from normal directly to T2D, and reversions from PreD to normal.

Methods: We examined the Geisinger Health System electronic health records and insurance claims data, segmenting a subject's medical history into normal, PreD, and/or T2D glycemic stages via diagnosis codes, glycosylated hemoglobin A1c (HbA1c) or fasting plasma glucose lab results, and use of anti-diabetic drugs.

Real-world clinical and economic outcomes of liraglutide versus sitagliptin in patients with type 2 diabetes mellitus in the United States.

Introduction: The objective of this study was to compare the clinical effectiveness of liraglutide with sitagliptin and assess the associated economic outcomes in patients with type 2 diabetes mellitus (T2DM) treated in real-world practice in the United States (US).

Methods: This retrospective cohort study used a large US claims database to identify patients with T2DM who initiated liraglutide or sitagliptin between January 2010 and December 2012. Adults (≥18 years old) with persistent use of therapy for ≥3 months were included.

Clinical effectiveness of liraglutide across body mass index in patients with type 2 diabetes in the United States: a retrospective cohort study.

Introduction: Clinical trials have shown that liraglutide effectively lowers glycated hemoglobin A1c (A1C) levels in adult patients with type 2 diabetes (T2D). However, no studies have evaluated the effectiveness of liraglutide by body mass index (BMI) in the United States (US) in clinical practice. This study examined liraglutide's clinical effectiveness to lower A1C and body weight after 6 months in T2D patients stratified by baseline BMI.

The association of body mass index with the risk of type 2 diabetes: a case-control study nested in an electronic health records system in the United States.

Objectives: Obesity is a known risk factor for type 2 diabetes (T2D). We conducted a case-control study to assess the association between body mass index (BMI) and the risk of being diagnosed with T2D in the United States.

Methods: We selected adults (≥ 18 years old) who were diagnosed with T2D (defined by ICD-9-CM diagnosis codes or use of anti-diabetic medications) between January 2004 and October 2011 ("cases") from an electronic health records database provided by an integrated health system in the Middle Atlantic region.

Examining the ability to detect change using the TRIM-Diabetes and TRIM-Diabetes Device measures.

Purpose: Responsiveness is defined as the ability of an instrument to accurately detect change when it has occurred and is an essential psychometric property of a patient-reported outcomes (PRO) measure to understand and interpret study findings. This study examined the responsiveness of 2 Treatment Related Impact Measures (TRIMs): The TRIM-Diabetes (TRIM-D) and TRIM-Diabetes Device (TRIM-DD) as well as confirmed their measurement models in a randomized controlled trial (RCT) design.

Methods: The data were collected in a multi-center, randomized, open-label (2 × 12 week), cross-over study of two prefilled pens in subjects with type 1 or type 2 diabetes, age 18 or older.

Results of a model analysis of the cost-effectiveness of liraglutide versus exenatide added to metformin, glimepiride, or both for the treatment of type 2 diabetes in the United States.

Background: Nearly half of all US patients with type 2 diabetes mellitus (T2DM) are unable to maintain adequate glycosylated hemoglobin (HbA₁(c)) control (ie, <7.0%).

Objective: The aim of this work was to determine the long-term cost-effectiveness of incretin-based therapy with once-daily liraglutide (vs twice-daily exenatide) combined with metformin, glimepiride, or both for the treatment of T2DM.

A comparison of preferences for two GLP-1 products--liraglutide and exenatide--for the treatment of type 2 diabetes.

Objective: To use time trade-off (TTO) to compare patient preferences for profiles of two glucagon-like peptide (GLP-1) products for the treatment of type 2 diabetes (liraglutide and exenatide) that vary on four key attributes - efficacy (as measured by hemoglobin A(1C)), incidence of nausea, incidence of hypoglycemia, and dosing frequency (QD vs. BID) - and measure the contribution of those attributes to preferences.

Methods: A total of 382 people with T2DM were recruited to participate in an internet-based survey consisting of a series of health-related questions, a conjoint exercise and a set of time trade-off items.

Patient-reported outcomes in patients with type 2 diabetes treated with liraglutide or glimepiride, both as add-on to metformin.

Patient-reported outcomes for liraglutide or glimepiride on metformin were investigated. Patients' treatment satisfaction on liraglutide was higher than with metformin alone and comparable with glimepiride+metformin. Patients perceived lower frequency of hypoglycaemia than glimepiride+metformin and lower frequency of hyperglycaemia than metformin.

Development and validation of the Treatment Related Impact Measure of Weight (TRIM-Weight).

Background: The use of prescription anti-obesity medication (AOM) is becoming increasingly common as treatment options grow and become more accessible. However, AOM may not be without a wide range of potentially negative impacts on patient functioning and well being. The Treatment Related Impact Measure (TRIM-Weight) is an obesity treatment-specific patient reported outcomes (PRO) measure designed to assess the key impacts of prescription anti-obesity medication.

Costs of managing severe hypoglycaemia in three European countries.

Objectives: To assess the costs of severe hypoglycaemic events (SHEs) in diabetes patients in Germany, Spain and the UK.

Methods: Healthcare resource use was measured by surveying 639 patients aged ≥ 16 years, receiving insulin for type 1 (n=319) or type 2 diabetes (n=320), who experienced ≥ 1 SHE in the preceding year. Patients were grouped by location of SHE treatment: group 1, community (family/domestic); group 2, community (healthcare professional); group 3, hospital.

A simulation of the comparative long-term effectiveness of liraglutide and glimepiride monotherapies in patients with type 2 diabetes mellitus.

Study Objective: To project and compare long-term outcomes of morbidity and mortality, and costs of complications of type 2 diabetes mellitus from a randomized controlled trial of patients receiving liraglutide versus glimepiride monotherapy.

Design: Mathematic simulation using the validated Center for Outcomes Research (CORE) Diabetes Model, calibrated to baseline patient characteristics from a short-term, randomized, controlled trial of liraglutide and glimepiride monotherapies (Liraglutide Effect and Action in Diabetes [LEAD]-3 trial) and using data from long-term outcomes studies.

Setting: Simulated routine clinical practice.