Initiation of iGlarLixi Versus Basal-Bolus Insulin in Adults With Type 2 Diabetes Advancing From Basal Insulin Therapy: The SoliComplex Real-World Study.

Background: When type 2 diabetes is suboptimally controlled with basal insulin, prandial insulin injections are commonly added (i.e., a basal-bolus insulin regimen), which can increase treatment burden and hypoglycemia risk. The once-daily injectable iGlarLixi is an alternative treatment. Methods: This retrospective analysis of the U.S. Optum Clinformatics database compared outcomes in adults (≥18 years of age) with type 2 diabetes who previously received basal insulin and were newly initiated on iGlarLixi or basal-bolus insulin therapy. Cohorts were propensity score-matched in a 1:1 ratio on baseline characteristics, and imbalances were adjusted in multivariate analyses. Subgroup analyses were performed for people ≥65 years of age and those with a baseline A1C ≥9%. The primary end point was persistence with therapy at 12 months in the overall population. Secondary end points were treatment adherence, health care resource utilization (HCRU), costs, any hypoglycemia, and A1C change at 12 months. Results: Cohorts each comprised 1,070 participants. Treatment persistence at 12 months was statistically significantly higher for iGlarLixi versus basal-bolus insulin therapy (43.7 vs. 22.3%, hazard ratio 0.51, 95% CI 0.46-0.57, adjusted P <0.001). Adherence was numerically higher for iGlarLixi, and hypoglycemia events, HCRU, and costs were numerically lower for iGlarLixi. A1C reduction from baseline was slightly greater for basal-bolus insulin. Results for both subgroups (≥65 years of age and baseline A1C ≥9%) were similar to those of the overall population. Conclusion: In this observational study, initiation of once-daily iGlarLixi versus basal-bolus insulin was associated with higher persistence, lower hypoglycemia, and similar A1C reduction without increasing HCRU or costs regardless of age or A1C. iGlarLixi could be an alternative to basal-bolus insulin, particularly for older adults with type 2 diabetes who require treatment simplification with lower hypoglycemia risk.

iGlarLixi versus premixed insulin initiation in adults with type 2 diabetes advancing from basal insulin therapy: The SoliComplex real-world study.

AIM: To compare outcomes in adults with type 2 diabetes (T2D) suboptimally controlled with basal insulin who initiated treatment with iGlarLixi or premixed insulin. METHODS: This retrospective real-world analysis was conducted using data from adults (age ≥ 18 years) with T2D in the US Optum Clinformatics database who had previously received basal insulin and newly initiated iGlarLixi or premixed insulin. Cohorts were propensity-score matched on baseline characteristics using a greedy nearest neighbour-matching algorithm, and outcomes were assessed at 12 months. Subgroup analyses were performed for those aged 65 years or older and those with a baseline HbA1c of 9% or higher. The primary endpoint was treatment persistence in the overall population. Secondary endpoints were treatment adherence, healthcare resource utilization (HRU), costs, hypoglycaemia events and change in HbA1c from baseline. RESULTS: Each cohort comprised 834 participants. In the overall population, treatment persistence at 12 months was statistically significantly higher for iGlarLixi versus premixed insulin: 42.5% versus 39.1%; hazard ratio 0.88; 95% confidence interval 0.778-0.998; P = .0465. Adherence and HbA1c reduction were similar between groups, whereas hypoglycaemia events, HRU and costs were numerically lower for iGlarLixi. Outcomes in both the age 65 years or older subgroup and in those with an HbA1c of 9% or higher were consistent with those for the overall population. CONCLUSIONS: In this observational study in people with T2D suboptimally controlled on basal insulin, once-daily iGlarLixi was an effective treatment alternative to premixed insulin with significantly higher treatment persistence, similar adherence and HbA1c reduction, and numerically lower hypoglycaemia events, HRU and costs, regardless of age or baseline HbA1c.

Improved patient-reported outcomes with iGlarLixi versus premix BIAsp 30 in people with type 2 diabetes in the SoliMix trial.

AIM: To assess patient-reported outcomes (PROs) in the SoliMix trial, which compared the efficacy and safety of iGlarLixi versus BIAsp 30 in people with type 2 diabetes (T2D). MATERIALS AND METHODS: SoliMix (EudraCT: 2017-003370-13), a 26-week, open-label study, randomized (1:1) 887 adults with T2D and HbA1c ≥7.5%-≤10.0% (≥58-≤86 mmol/mol) on basal insulin plus oral antihyperglycaemic drugs (OADs) to once-daily iGlarLixi or twice-daily premix insulin, BIAsp 30. PROs were assessed using the Treatment-Related Impact Measure Diabetes (TRIM-D) and Global Treatment Effectiveness Evaluation (GTEE) questionnaires. RESULTS: Over 26 weeks, iGlarLixi showed greater improvement from baseline versus BIAsp 30 in total TRIM-D score (least squares mean difference [95% confidence interval]: 5.08 [3.69, 6.47]; effect size: 0.32) and in each TRIM-D domain, with the greatest differences seen in diabetes management (8.47 [6.11, 10.84]) and treatment burden (6.95 [4.83, 9.07]). GTEE scores showed a greater proportion of participants and physicians rated a complete or marked improvement of diabetes control with iGlarLixi (80.5%, 82.8%) versus BIAsp 30 (63.3%, 65.1%) at week 26. Post hoc analyses showed that after adjusting for HbA1c, body weight and hypoglycaemia outcomes, iGlarLixi continued to show greater improvements in TRIM-D total scores versus BIAsp 30. CONCLUSIONS: In addition to better glycaemic control, weight benefit and less hypoglycaemia, once-daily iGlarLixi provided improved diabetes management, treatment burden and perceived effectiveness versus twice-daily premix BIAsp 30, further supporting iGlarLixi as an advanced treatment option in people with suboptimally controlled T2D on basal insulin plus OADs.

Cost-Effectiveness of iGlarLixi Versus Premix BIAsp 30 in People with Type 2 Diabetes Suboptimally Controlled by Basal Insulin in the US.

INTRODUCTION: Many people with type 2 diabetes mellitus (T2DM) experience suboptimal glycemic control and require therapy advancement. This cost-effectiveness analysis was conducted to compare iGlarLixi (insulin glargine 100 U/mL plus lixisenatide) versus BIAsp 30 (biphasic insulin aspart 30) in people with T2DM suboptimally controlled with basal insulin. METHODS: The IQVIA Core Diabetes Model was used to estimate lifetime costs and outcomes for people with T2DM from a US healthcare payer perspective. Initial clinical data were based on the phase 3 randomized, open-label, active-controlled SoliMix clinical study, which compared the efficacy and safety of once-daily iGlarLixi with twice-daily BIAsp 30. Lifetime costs (US$) and quality-adjusted life-years (QALYs) were predicted, and the incremental cost-effectiveness ratio (ICER) for iGlarLixi versus BIAsp 30 was estimated; the willingness-to-pay threshold was considered to be $50,000. A subgroup analysis considered people with T2DM aged ≥ 65 years. RESULTS: Estimated QALYs gained were slightly higher with iGlarLixi compared with BIAsp 30 (9.3 vs. 9.2), with lower costs for iGlarLixi ($117,854 vs. $120,109); the ICER for iGlarLixi was therefore considered dominant over BIAsp 30 in the base case. Key drivers for cost savings were the higher dose and twice-daily administration for BIAsp 30 versus once-daily administration for iGlarLixi. The robustness of the base-case results was confirmed by sensitivity and scenario analyses. Results were similar in a subgroup of people with T2DM aged ≥ 65 years. CONCLUSION: In people with T2DM with suboptimal glycemic control on basal insulin, iGlarLixi confers improved QALYs and reduced costs compared with BIAsp 30.

Cost-Effectiveness of iGlarLixi Versus Premix BIAsp 30 in Patients with Type 2 Diabetes Suboptimally Controlled by Basal Insulin in the UK.

INTRODUCTION: iGlarLixi is indicated as an adjunct to diet and exercise in addition to metformin (with or without sodium-glucose cotransporter-2 inhibitors) to improve glycemic control in adults with insufficiently controlled type 2 diabetes (T2D). A cost-effectiveness analysis was conducted to compare iGlarLixi with premix biphasic insulin aspart 30 (BIAsp 30) in people with T2D suboptimally controlled with basal insulin (BI). METHODS: The IQVIA CORE Diabetes Model was used to estimate lifetime costs and outcomes for people with T2D from a UK health care perspective at a willingness-to-pay threshold of £20,000. Initial clinical data were based on the phase 3 randomized, open-label, active-controlled SoliMix clinical trial which compared the efficacy and safety of once-daily iGlarLixi with that of twice-daily BIAsp 30. Costs associated with management and complications and utilities values were derived from published sources. Lifetime costs (in £GBP) and quality-adjusted life-years (QALYs) were predicted; extensive scenario and sensitivity analyses were conducted. RESULTS: Estimated QALYs gained were slightly higher with iGlarLixi (8.9 vs. 8.8) compared with premix BIAsp 30, at a higher cost (£23,204 vs. £21,961). The base case incremental cost-effectiveness ratio (ICER) per QALY was £13,598. Treatment acquisition was the main driver of cost differences (iGlarLixi, £11,750; premix BIAsp 30, £10,395). Costs associated with management and complications were generally similar between comparators. CONCLUSION: iGlarLixi provides improved QALY outcomes at an acceptable cost compared with premix BIAsp 30, with an ICER below the threshold generally considered acceptable by UK authorities. In people with T2D, iGlarLixi is a simple, cost-effective option for advancing therapy of BI, with fewer daily injections than premix BIAsp 30.

Characterization of uncontrolled, severe asthma patients with type 2 inflammation (T2): results from a physician survey across countries from Latin American, Eurasian Middle East regions and China.

OBJECTIVE: The 2019 GINA guidance incorporates the presence of T2 inflammation in severe asthma patients to determine eligibility for add-on biologic therapy, though little data exists to characterize this population. The objective of this manuscript is to conduct a descriptive analysis to characterize patients with severe asthma in emerging countries based on disease severity, patient exacerbation history, and T2 phenotype. METHODS: A cross-sectional survey of physicians treating asthma patients ages 12 years and older was conducted in eight countries. Physicians characterized their severe asthma patients and reported data from their patients' medical charts. Medical chart data was selected from the physicians' six most recent asthma patients taking prescription medication. RESULTS: A total of 550 physicians completed the survey and filled out 3,300 patient record forms. A total of 876 patients have been characterized with uncontrolled severe asthma. Of the 420 patients with available EOS lab data, 40% are indicated with T2 inflammation (EOS ≥150/µL). Ninety-one percent of all patients with available IgE lab data (n = 498) had IgE 30 - 1500 IU/mL indicating allergy-driven asthma. Finally, chronic OCS use (as reported by physicians) was reported in 11% of patients. CONCLUSION: This research revealed that 65% of patients had at least one of three T2 inflammation comorbidities assessed: allergic rhinitis, chronic rhinosinusitis with nasal polyps, and atopic dermatitis. Discrepancies were observed between patients' treatment regimens and GINA step reported, suggesting there may be room to improve understanding of asthma severity as defined per GINA guidelines as well as asthma control assessment in clinical practice.

Cost-Effectiveness of iGlarLixi in People with Type 2 Diabetes Mellitus Suboptimally Controlled on Basal Insulin Plus Metformin in the UK.

INTRODUCTION: A cost-effectiveness analysis was conducted comparing a fixed-ratio combination (FRC) of insulin glargine 100 units/mL plus lixisenatide (iGlarLixi) versus the FRC of insulin degludec plus liraglutide (iDegLira) and the free-combination comparators insulin glargine plus dulaglutide (iGlar plus Dula) and basal insulin plus liraglutide (BI plus Lira). METHODS: The IQVIA Core Diabetes Model was used to estimate lifetime costs and outcomes for a cohort of patients with type 2 diabetes mellitus (T2DM) from the UK healthcare perspective. Initial clinical data for iGlarLixi were based on the randomized, controlled LixiLan-L trial and the relative treatment effects for comparators were based on an indirect treatment comparison using data from the AWARD-9 (iGlar plus Dula), LIRA ADD2 BASAL (BI plus Lira), and DUAL V (iDegLira) trials. Costs were derived from publicly available sources. Lifetime costs (in British Pound Sterling [£]) and quality-adjusted life-years (QALYs) were predicted; net monetary benefit (NMB) for iGlarLixi versus comparators was derived using a willingness-to-pay threshold of £20,000. Extensive scenario and sensitivity analyses were conducted. RESULTS: Estimated costs were lowest with iGlarLixi (£31,295) compared with iGlar plus Dula (£38,790), iDegLira (£40,179), and BI plus Lira (£42,467). Total QALYs gained were identical with iGlarLixi and iDegLira (8.438), and comparable with iGlar plus Dula (8.439) and BI plus Lira (8.466). NMB for iGlarLixi was positive versus all comparators (£10,603.86 vs. BI plus Lira; £7,466.24 vs. iGlar plus Dula; £8.874.11 vs. iDegLira). CONCLUSION: In patients with T2DM with suboptimal glycemic control on basal insulin, iGlarLixi provides very similar outcomes and substantial cost savings, compared with other fixed and free combinations of insulins plus glucagon-like peptide-1 receptor agonists.

Cost-Effectiveness of iGlarLixi Versus iDegLira in Type 2 Diabetes Mellitus Inadequately Controlled by GLP-1 Receptor Agonists and Oral Antihyperglycemic Therapy.

INTRODUCTION: The fixed-ratio combinations (FRCs) of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) and basal insulin, insulin glargine 100 U/mL plus lixisenatide (iGlarLixi), and insulin degludec plus liraglutide (iDegLira), have demonstrated safety and efficacy in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on GLP-1 RAs. However, a comparative cost-effectiveness analysis between these FRCs from a UK Health Service perspective has not been conducted. METHODS: The IQVIA Core Diabetes Model was used to estimate lifetime costs and outcomes in patients with T2DM receiving iGlarLixi (based on the LixiLan-G trial) versus iDegLira (based on relative treatment effects from an indirect treatment comparison using data from DUAL III). Utilities, medical costs, and costs of diabetes-related complications were derived from literature. Model outputs included costs and quality-adjusted life years (QALYs). Incremental cost-effectiveness ratios were calculated with a local willingness-to-pay threshold of £20,000 per QALY. Extensive scenario, one-way sensitivity, and probabilistic sensitivity analyses were conducted to evaluate the robustness of the model. RESULTS: iGlarLixi was less costly (iGlarLixi, £30,011; iDegLira, £40,742), owing to lower acquisition costs, and similar in terms of QALYs gained (iGlarLixi, 8.437; iDegLira, 8.422). Extensive scenario and sensitivity analyses supported the base case findings. CONCLUSION: In patients with T2DM and inadequate glycemic control despite GLP-1 RAs, use of iGlarLixi was associated with substantial cost savings and comparable utility outcomes. iGlarLixi can be considered as cost-effective versus iDegLira from the UK Health Service perspective.

Evaluating glycaemic control in patients poorly controlled on oral antidiabetic drugs in real-world setting: Results from assessing the Appropriate Timing of Type 2 diAbetes INtensification (ATTAIN).

INTRODUCTION: Many patients with type 2 diabetes mellitus (DM) fail to achieve glycaemic control despite recommended treatment strategies to reduce glycated haemoglobin (HbA1c). This real-world retrospective cohort study compared HbA1c change and treatment patterns between those intensifying and not intensifying therapy with oral antidiabetic drugs (OADs). MATERIALS AND METHODS: Patients suboptimally controlled on OADs (>58 mmol/mol [>7.5%] or >64 mmol/mol [>8.0%] for high risk, index 1) were included from IQVIA Medical Research Data. Intensifiers within 12 months of index 1 were matched (1:1) to nonintensifiers. Primary outcomes were HbA1c change and proportion of participants achieving HbA1c targets 6 and 12 months post-index 2 (date of intensification [intensifiers] or pseudodate [nonintensifiers]). Therapy adherence was also assessed. RESULTS: A total of 10 832 participants (5539 intensifiers and 5293 nonintensifiers) were included. Mean HbA1c decrease from baseline to 6 months was -1.13% (intensifiers) vs -0.75% (nonintensifiers), with no substantial further change at 12 months. Cox proportional hazards (PH) analysis suggested a nearly 20% greater chance of target achievement at 6 months for intensifiers vs nonintensifiers (hazard ratio [HR]: 0.79 [95% confidence interval [CI]: 0.73-0.86]), which was similar at 12 months (HR: 0.80 [95% CI: 0.74-0.86]). Intensifiers tended towards greater adherence to baseline therapy (90% [standard deviation (SD): 14.9] vs nonintensifiers 87% [SD: 16.0]), which decreased following intensification. CONCLUSIONS: Significant reductions in HbA1c were evident at 6 months and were greater in intensifiers vs nonintensifiers. Little additional clinical benefit was seen 12 months postintensification. Despite good treatment adherence, many participants failed to achieve target HbA1c; actions beyond improved adherence are needed to improve suboptimal HbA1c.

The Use of Computer Simulation Modeling to Estimate Complications in Patients with Type 2 Diabetes Mellitus: Comparative Validation of the Cornerstone Diabetes Simulation Model.

OBJECTIVE: The objective of this study was to assess the validity of the Cornerstone Diabetes Simulation (CDS), a Microsoft Excel®-based patient-level simulation for type 2 diabetes mellitus based on risk equations from the revised United Kingdom Prospective Diabetes Study Outcomes Model (UKPDS-OM2, also known as UKPDS 82). METHODS: Three levels of validation were conducted. Internal validation was assessed through independent review and model stress-testing. External validation was addressed by populating the CDS with baseline characteristics and treatment effects from three major diabetes clinical trials used in the Fifth Mount Hood Diabetes Challenge (MH5) for computer simulation models. Cross-validation of predicted outcomes was tested versus eight models that participated in the MH5. Simulated results were compared with observed clinical outcomes via the coefficient of determination (R2) for both the absolute risk of each clinical outcome and the difference in absolute risk between control and intervention arm in each trial. We ensured transparency of all model inputs and assumptions in reporting. RESULTS: The CDS could be used to predict 18 of 39 single and composite endpoints across the three trials. The model obtained an R2 of 0.637 for predicted versus observed absolute risks, and an R2 of 0.442 for predicted versus observed risk differences between control and intervention. Among the other eight models, only one obtained a higher R2 value under both definitions, albeit based on only four predicted endpoints. CONCLUSIONS: The CDS provides good predictions of diabetes-related complications when compared to observed trial outcomes and previously validated models. The model has value as a validated tool in cost-effectiveness evaluations.

Evaluating Glycemic Control in Patients with Type 2 Diabetes Suboptimally Controlled on Basal Insulin: UK ATTAIN Real-World Study.

INTRODUCTION: This retrospective, observational cohort study evaluated the effect of therapy intensification on change in glycated hemoglobin (HbA1c) at 6 and 12 months post intensification in patients with type 2 diabetes (T2D) suboptimally controlled on basal insulin (BI) (i.e., HbA1c ≥ 7.5% [≥ 58 mmol/mol]). METHODS: Patients with T2D with suboptimal glycemic control using BI were identified from The Health Improvement Network (THIN) database. Patients who underwent therapy intensification (intensifiers) within 12 months of index 1 (the date of the first incidence of suboptimally controlled HbA1c) were matched (1:1) to patients who did not intensify therapy (non-intensifiers). Index 2 was the date of therapy intensification for intensifiers, or a pseudo date for non-intensifiers that resulted in the same duration from index 1 to index 2 as their matched intensifier patient. Primary outcomes were HbA1c change and proportion of patients achieving the HbA1c target at 6 and 12 months post index 2. RESULTS: A total of 1342 patients (n = 646 intensifiers; n = 696 non-intensifiers) were included in the analysis. At post index 2, mean HbA1c change was substantially greater at 6 months for intensifiers than for non-intensifiers (- 0.81% vs. - 0.35%), with no additional benefit at 12 months (- 0.81% vs. - 0.49%, respectively). Compared with non-intensifiers, a greater proportion of intensifiers achieved target HbA1c at 6 months (25.1% vs. 18.8%) and at 12 months (33.4% vs. 28.2%). CONCLUSIONS: Many real-world patients with T2D suboptimally controlled with BI do not have their therapy intensified. The results of this study suggest that in this patient population, therapy intensification achieves significant reductions in HbA1c at 6 months post intensification, with little additional clinical benefit at 12 months. This suggests that, for patients who fail to achieve their glycemic targets at 6 months, since no meaningful additional clinical benefit is observed at 12 months when continuing the same therapy, further therapy intensification or change should be promptly considered. FUNDING: This study and the Rapid Service Fees were funded by Sanofi. TRIAL REGISTRATION: 17THIN068.

Clinical implications of prolonged hyperglycaemia before basal insulin initiation in type 2 diabetes patients: An electronic medical record database analysis.

AIMS: To assess the effect of duration of hyperglycaemia before basal insulin (BI) initiation on clinical outcomes in type 2 diabetes (T2D). MATERIALS AND METHODS: Patients with T2D who initiated BI during 2009-2013, had continuous enrolment for ≥2 years preceding and ≥1 year following BI initiation ("index date"), and had ≥1 glycated haemoglobin (A1C) measure not at target (ie, ≥7.0%) within 6 months preindex date were included in the study. Patients were stratified by preindex-date duration of A1C ≥7.0%. Longitudinal A1C, weight, BMI, and diabetes medication were compared between cohorts for up to 15-month follow-up. RESULTS: Of 37 053 patients who initiated BI, 40.7%, 15.3%, 16.0%, and 28.0%, respectively, had uncontrolled A1C for <6, 6-<12, 12-<18 and 18-24 months preindex date. Baseline characteristics were similar between cohorts. Baseline A1C values were similar across cohorts (9.2%-9.6%). Mean follow-up A1C values were higher with longer preindex-date duration of uncontrolled A1C (8.0 ± 1.7%, 8.2 ± 1.6%, 8.5 ± 1.7%, and 8.6 ± 1.7% for <6, 6-<12, 12-<18, and 18-24 months); attainment of A1C <7.0% worsened with increasing preindex-date duration of A1C ≥7.0% (29.6%, 20.0%, 14.6%, and 11.5% for <6, 6-<12, 12-<18, and 18-24 months). CONCLUSIONS: These data suggest that longer duration of uncontrolled A1C before BI initiation increases the risk of not reaching glycaemic targets. However, target attainment was poor in all cohorts, highlighting inadequate glycaemic control as an important unmet need in US patients with T2D.

Lack of Treatment Persistence and Treatment Nonadherence as Barriers to Glycaemic Control in Patients with Type 2 Diabetes.

Treatment persistence (continuing to take medication for the prescribed period) and treatment adherence (complying with the prescription in terms of drug schedules and dosage) are both important when treating chronic diseases such as type 2 diabetes (T2D). They can be indicators of patient satisfaction with treatment. In T2D, the achievement of optimal outcomes requires both persistence with and adherence to prescribed therapy. Poor persistence with and adherence to T2D medication can have profound consequences for the patient, including non-achievement of glycaemic goals and an increased risk of long-term complications and mortality. Therefore, poor treatment persistence and adherence may also have economic consequences, including increased healthcare resource utilization and healthcare costs. Treatment persistence and adherence are affected by several factors, including the mode of administration, administration frequency/regimen complexity, and patient expectations. The aims of this review are as follows: to provide an overview of persistence with and adherence to different antidiabetes therapies for patients with T2D in the real-world setting; examine factors contributing to poor treatment persistence and adherence; and assess available data on the impact of poor treatment persistence and/or adherence on clinical and economic outcomes. Numerous potential targets for improving treatment persistence and/or adherence are identified, including developing less complex treatment regimens with lower pill burdens or less frequent injections, improving the convenience of drug-delivery systems, such as the use of insulin pen devices rather than the conventional vial and syringe, and developing therapies with an improved safety profile to alleviate patient fears of adverse effects, such as weight gain and risk of hypoglycaemia.Funding: Sanofi.

Treatment Intensification in Type 2 Diabetes: A Real-World Study of 2-OAD Regimens, GLP-1 RAs, or Basal Insulin.

INTRODUCTION: Treatment guidelines recommend a stepwise approach to glycemia management in patients with type 2 diabetes (T2D), but this may result in uncontrolled glycated hemoglobin A1c (HbA1c) between steps. This retrospective analysis compared clinical and economic outcomes among patients with uncontrolled T2D initiating two oral antidiabetes drugs (OADs), glucagon-like peptide-1 receptor agonists (GLP-1 RAs), or basal insulin in a real-world setting. METHODS: Adults with T2D on OAD monotherapy were identified in the MarketScan claims database (2007-2014). Those initiating two OADs (simultaneously or sequentially), GLP-1 RAs, or basal insulin were selected (date of initiation was termed the 'index date'); patients were required to have HbA1c > 7.0% in the 6 months pre-index date. HbA1c was compared from 6 months pre- to 1-year post-index. Annual all-cause healthcare utilization and costs were reported over the 1-year follow-up period. RESULTS: Data for 6054 patients were analyzed (2-OAD, n = 4442; GLP-1 RA, n = 361; basal insulin, n = 1251). Baseline HbA1c was high in all cohorts, but highest in the basal-insulin cohort. Treatment initiation resulted in reductions in HbA1c in all cohorts, which was generally maintained throughout the follow-up period. Average HbA1c reductions from the 6 months pre- to 1 year post-index date were -1.2% for GLP-1 RA, -1.6% for OADs, and -1.8% for basal insulin. HbA1c < 7.0% at 1 year occurred in 32.6%, 47.5%, and 41.1% of patients, respectively. Annual healthcare costs (mean [SD]) were lowest for OAD (US$10,074 [$22,276]) followed by GLP-1 RA (US$14,052 [$23,829]) and basal insulin (US$18,813 [$37,332]). CONCLUSION: Despite robust HbA1c lowering following treatment initiation, many patients did not achieve HbA1c < 7.0%. Basal insulin, generally prescribed for patients with high baseline HbA1c, was associated with a large reduction in HbA1c and with higher costs. Therapy intensification at an appropriate time could lead to clinical and economic benefits and should be investigated further. FUNDING: Sanofi U.S., Inc.

Impact of delaying treatment intensification with a glucagon-like peptide-1 receptor agonist in patients with type 2 diabetes uncontrolled on basal insulin: A longitudinal study of a US administrative claims database.

AIM: To evaluate the effect of delaying treatment intensification with a glucagon-like peptide-1 receptor agonist (GLP-1 RA) on clinical and economic outcomes in patients with type 2 diabetes (T2D). METHODS: We conducted a retrospective observational claims study using IMPACT (Impact National Managed Care Benchmark Database) in adult patients with T2D who initiated basal insulin between January 1, 2005 and December 31, 2012, with or without OADs, who remained uncontrolled (glycated haemoglobin [HbA1c] ≥7.0%). Patients were categorized into 3 groups: early, delayed, and no intensification with a GLP-1 RA. We evaluated changes from baseline to follow-up at 12 months for HbA1c level, rate of hypoglycaemic events, and healthcare costs, and we assessed the association between baseline patient characteristics and subsequent treatment intensification. RESULTS: A total of 139 patients (9.0% of 1552 eligible patients) met criteria for inclusion in the early intensification group, 588 patients (37.9%) met criteria for inclusion in the delayed intensification group, and 825 patients (53.2%) met criteria for inclusion in the no intensification group. Mean baseline HbA1c values were 9.16%, 9.07%, and 9.34%, respectively. At follow-up, delayed intensification was associated with significantly smaller decreases in HbA1c from baseline (-0.68%) compared with early intensification (-1.01%). Rates of overall hypoglycaemia were numerically greater in the delayed intensification group than in the early intensification group (0.26 vs 0.06 events/patient-years of exposure, respectively). Change in semi-annual total healthcare costs was greater in the no intensification group (+5266 USD) compared with the early intensification group (-560 USD) and the delayed intensification group (+1943 USD). CONCLUSIONS: Timely addition of a GLP-1 RA to therapy for patients with T2D who were not adequately controlled with basal insulin is associated with better clinical and economic outcomes.

Evaluating drug cost per responder and number needed to treat associated with lixisenatide on top of glargine when compared to rapid-acting insulin intensification regimens on top of glargine, in patients with type 2 diabetes in the UK, Italy, and Spain.

OBJECTIVES: This study investigated the cost per responder and number needed to treat (NNT) in type 2 diabetes mellitus (T2DM) patients for lixisenatide compared to insulin intensification regimens using composite endpoints in the UK, Italy, and Spain. METHODS: Efficacy and safety outcomes were obtained from GetGoal Duo-2, a 26-week phase 3 trial comparing lixisenatide vs insulin glulisine (IG) once daily (QD) and three times daily (TID). Response at week 26 was extrapolated to 52 weeks, assuming a maintained treatment effect, based on long-term evidence in other T2DM populations. Responders were defined using composite end-points, based on an HbA1c threshold and/or no weight gain and/or no hypoglycemia. The HbA1c threshold was varied in sensitivity analyses. Annual treatment costs were estimated in euros (1 GBP = 1.26 EUR), including drug acquisition and resource use costs. Cost per responder was computed by dividing annual treatment costs per patient by the proportion of responders. RESULTS: Lixisenatide was associated with the lowest cost per responder for all composite end-points that included a weight-related component. For the main composite end-point of HbA1c ≤7.5% AND no weight gain AND no symptomatic hypoglycemia, cost per responder results were: UK: 6,867€, 8,746€, and 12,410€; Italy: 7,057€, 9,160€, and 12,844€; Spain: 8,370€, 11,365€, and 17,038€, for lixisenatide, IG QD, and TID, respectively. The NNT analysis showed that, for every 6.85 and 5.86 patients treated with lixisenatide, there was approximately one additional responder compared to IG QD and TID, respectively. LIMITATIONS: A limitation of the clinical inputs is the lack of 52-week trial data from GetGoal Duo-2, which led to the assumption of a maintained treatment effect from week 26 to 52. CONCLUSIONS: This analysis suggests lixisenatide is an efficient economic resource allocation in the UK, Italy, and Spain.