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Aims/Introduction: Treatment intensification is commonly delayed in people with type 2 diabetes, resulting in poor glycemic control for an unacceptable length of time and increased risk of complications. Materials and Methods: This retrospective study investigated clinical inertia in 33,320 Japanese adults with type 2 diabetes treated with oral antidiabetic drugs (OADs) between 2009 and 2018, using data from the Computerized Diabetes Care (CoDiC®) database. Results: The median time from first reported glycated hemoglobin (HbA1c) ≥7.0% (≥53 mmol/mol) to treatment intensification was considerably longer and HbA1c levels were higher the more OADs the patient was exposed to. For patients receiving three OADs, the median times from HbA1c ≥7.0% (53 mmol/mol) to intensification with OAD, glucagon‐like peptide‐1 receptor agonist or insulin were 8.1, 9.1 and 6.7 months, with a mean HbA1c level at the time of intensification of 8.4%, 8.9% and 9.3%, respectively. The cumulative incidence for time since the first reported HbA1c ≥7.0% (≥53 mmol/mol) to intensification confirmed the existence of clinical inertia, identifying patients whose treatment was not intensified despite poor glycemic control. HbA1c levels ≥7.0% (≥53 mmol/mol) after ≥6 months on one, two or three OADs were observed in 42%, 51% and 58% of patients, respectively, showing that approximately 50% of patients are above HbA1c target regardless of how many OADs they take. Conclusions: Real‐world data here show clinical inertia in Japanese adults with type 2 diabetes from early diabetes stages when they are receiving OADs, and illustrate a need for earlier, more effective OADs or injectable treatment intensification and better communication around the existence of clinical inertia. [ABSTRACT FROM AUTHOR]

Introduction: Reliable quality of life (QoL) measures and utility values are needed for patients with type 2 diabetes mellitus (T2DM) with a variety of comorbid conditions to help facilitate cost-effectiveness modeling. This study aimed to evaluate the Diabetes Treatment-Related Quality of Life (DTR-QOL) and EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaires in patients with T2DM with and without diabetes complications and comorbidities in Japan. Methods: This was an observational survey study involving 1000 patients with T2DM, at least 20 years old, receiving treatment at Nara University Hospital or Takamura Internal Medicine Clinic in Japan. Patients completed the DTR-QOL and EQ-5D-5L questionnaires and clinicians completed an accompanying case report form. The DTR-QOL and EQ-5D-5L are scored on a scale of 0–100 and 0–1, with 100 and 1 representing the best possible scores, respectively. Results: Out of 1000 recruited patients, 978 were included in the final analysis. Patients reported an average EQ-5D-5L value of 0.92 ± 0.11. Utility values corresponded to the degree of severity of health conditions while few differences were observed when stratified by the HbA1c 7% threshold, age, or BMI level, nor did the values correspond to the degree of clinical risk factors. Patients reported an average total DTR-QOL score of 79.26 ± 13.26. The DTR-QOL was sensitive to detect differences in patients with T2DM with a variety of complications and comorbidities, risk factors, and treatments. Conclusion: This is the largest study to report QOL values for patients with diabetes in Japan and the first to include a variety of comorbid diabetic conditions. These findings may be useful for cost-effectiveness modeling of patients with T2DM in Japan. [ABSTRACT FROM AUTHOR]

Introduction: The incidence and prevalence of type 2 diabetes mellitus (T2D) are increasing in Japan, and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are commonly used to treat the disease. The objective of this study was to use a discrete choice experiment (DCE) to characterize patient preferences for clinical treatment features of two GLP-1 RAs—dulaglutide 0.75 mg and semaglutide 0.50 mg—among patients with T2D in Japan. Methods: Adult patients with T2D in Japan were administered the DCE via a web-based survey. The DCE examined patient preferences for five treatment attributes (each described by two or three levels), including method of administration, HbA1c change, reduction in cardiovascular (CV) risk, weight change, and common side effects (i.e., nausea). Results were analyzed using multinomial and mixed logit models, and predicted choice probability was calculated to determine the overall probability that either dulaglutide or semaglutide DCE levels were preferred. One DCE choice task included a direct comparison of the dulaglutide 0.75 mg versus semaglutide 0.50 mg treatment profiles. Results: 190 subjects completed the survey; 29 were excluded after failing the predefined internal validity assessments. In the final analysis sample (N = 161), the attribute with the largest effect on the subjects' choices was reduction in CV risk, followed by HbA1c change and common side effects. Patients' predicted choice probability for the semaglutide profile was 78%, versus 22% for the dulaglutide profile. 28% of patients were "very willing" to initiate treatment with semaglutide's product profile, versus 6% for dulaglutide. Conclusion: In this study, reduction in CV risk and HbA1c change were the key drivers of GLP-1 RA medication preference in Japanese patients with T2D. Overall, the majority of the patients preferred a product with attribute levels reflecting the semaglutide 0.50 mg profile, with a known CV risk reduction benefit and superior HbA1c reduction. Funding: Novo Nordisk. [ABSTRACT FROM AUTHOR]

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.Methods: The cost per patient achieving treatment target (cost of control) was assessed for various single and composite endpoints for the entire trial population and in patients with baseline glycated hemoglobin (HbA1c) >8.0% and HbA1c >9.0%. The proportions of patients achieving treatment targets were analyzed using data obtained in the DUAL V study. Costs were accounted based on published wholesale acquisition costs.Results: When assessing the full trial population, IDegLira was associated with lower annual cost of control than continued up-titration of insulin glargine U100 for patients achieving HbA1c ≤6.5% without confirmed hypoglycemia (by $10,608), HbA1c ≤6.5% without weight gain (by $29,215), and HbA1c ≤6.5% without confirmed hypoglycemia and weight gain (by $57,351). A similar pattern was observed when multifactorial treatment targets were based on achieving a glycemic target of 7.0%. When only HbA1c was considered, IDegLira was associated with a lower cost per patient achieving HbA1c ≤6.5% (by $3306) but cost of control was equivalent for a target of HbA1c <7.0%. In patients with baseline HbA1c >8.0% and HbA1c >9.0%, IDegLira was associated with a lower cost of control for all treatment targets.Conclusion: The significantly greater clinical efficacy in terms of bringing patients to treatment targets identified in the DUAL V study results in lower cost of control values for IDegLira versus continued up-titration of insulin glargine U100 in the USA. This suggests IDegLira is a cost-effective treatment option in the USA.Funding: Novo Nordisk A/S and Novo Nordisk Inc. [ABSTRACT FROM AUTHOR]

Background: The effectiveness of a drug is signifi-cantly influenced by a patient's adherence to the re-quired regimen Objective: The goal of this retrospective database analysis was to determine the factors affecting adher-ence over a 12-month follow-up period in adults with type 2 diabetes mellitus (DM) initiating once-daily li- raglutide (1.8 mg) or twice-daily exenatide (10 μg). Methods: A patient-centric claims database was used, covering the period January 2009 to December 2011. Patients were included if they had ≥1 claim of once-daily liraglutide 1.8 mg or twice-daily exenatide 10 μxg from January to December 2010 (index date [ID]), >2 diagnoses of type 2 DM before ID, continu-ous enrollment for 12 months before and after ID, and age ≥18 years at ID. Patients were required to be glu-cagon-like peptide-1 receptor agonist treatment-naive in the 12 months preceding ID and have a second pre-scription for once-daily liraglutide 1.8 mg or twice-daily exenatide 10 ixg during the 12 months after ID. The medication possession ratio (MPR) was used as a continuous variable and to categorize patients as high-adherent (MPR >80%) or low-adherent (MPR <80%). Regression analyses were conducted to deter-mine the predictors for nonadherence in the type 2 DM population, with bivariate testing of the MPR catego-ries conducted initially to determine the predictors to be included in the final regression model. Results: A total of 3623 patients (once-daily liraglu-tide 1.8 mg, n = 2036; twice-daily exenatide 10 μg, n = 1587) were identified. Variables found to reduce adherence were younger age, female sex, Southern geo-graphic region, twice-daily exenatide treatment, and higher percentage of copayment from the claimant. Af-ter adjusting for confounding factors, patients receiv-ing once-daily liraglutide 1.8 mg were ~11% more adherent than patients receiving twice-daily exenatide 10 μg (95% CI, 7-14; P < 0.0001). The odds ratio for "poor" adherence (MPR <80%) with twice-daily ex-enatide 10 μg therapy compared with liraglutide 1.8 mg once-daily was 1.33 (95% CI, 1.16-1.53; P < 0.0001). Conclusions: This study found that adherence to once-daily liraglutide 1.8 mg treatment was superior to twice-daily exenatide 10 ig over a 12-month follow-up period. Nonadherence has important implications to the health care system, both in terms of clinical effectiveness and economic burden (eg, hospitalization, productivity losses). Using strategies to increase adherence is vital to reduce the future clinical and economic burden of diabetes. [ABSTRACT FROM AUTHOR]

Abstract: Background: The global clinical and economic burden of type 2 diabetes is substantial. Recently, clinical trials with glucagon-like peptide-1 (GLP-1) receptor agonists (liraglutide and exenatide) have shown a multifactorial clinical profile with the potential to address many of the clinical needs of patients and reduce the burden of disease. Objective: The goal of this study was to evaluate the long-term cost-effectiveness of once-daily liraglutide versus exenatide BID in patients with type 2 diabetes who failed to improve with metformin and/or sulfonylurea, based on the results of a previous clinical trial in 6 European countries (Switzerland, Denmark, Norway, Finland, the Netherlands, and Austria). Methods: A validated computer simulation model of diabetes was used to predict life expectancy, quality-adjusted life years (QALYs), and incidence of diabetes-related complications in patients receiving liraglutide (1.8 mg once daily) or exenatide (10 μg BID). Baseline cohort characteristics and treatment effects were derived from the Liraglutide Effect and Action in Diabetes 6 trial. Country-specific complication costs were taken from published sources. Simulations were run over 40 years from third-party payer perspectives. Future costs and clinical benefits were discounted at country-specific discount rates. Sensitivity analyses were performed. Results: Liraglutide was associated with improvements of 0.12 to 0.17 QALY and a reduced incidence of most diabetes-related complications versus exenatide in all settings. Evaluation of total direct medical costs (treatment plus complication costs) suggest that liraglutide was likely to cost between Euro (€) 1023 and €1866 more than exenatide over patients'' lifetimes, leading to incremental cost-effectiveness ratios per QALY gained versus exenatide of: Switzerland, CHF (Swiss francs) 10,950 (€6902); Denmark, Danish krone [kr] 88,160 (€11,805); Norway, Norwegian krone [kr], 111,916 (€13,546); Finland, €8459; the Netherlands, €8119; and Austria, €8516. Conclusions: Long-term projections indicated that liraglutide was associated with benefits in life expectancy, QALYs, and reduced complication rates versus exenatide. Liraglutide was cost-effective from a health care payer perspective in Switzerland, Denmark, Norway, Finland, the Netherlands, and Austria. Clinicaltrials.gov identifier: NCT 00518882. [Copyright &y& Elsevier]