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Background: This analysis assessed the cost‐effectiveness of insulin glargine 300 units/mL (Gla‐300) versus insulin glargine 100 units/mL (Gla‐100) in insulin‐naïve adults with type 2 diabetes (T2D) inadequately controlled with oral antidiabetic drugs (OADs). Methods: Costs and outcomes for Gla‐300 versus Gla‐100 from a US healthcare payer perspective were assessed using the BRAVO diabetes model. Baseline clinical data were derived from EDITION‐3, a 12‐month randomized controlled trial comparing Gla‐300 with Gla‐100 in insulin‐naïve adults with inadequately controlled T2D on OADs. Treatment costs were calculated based on doses observed in EDITION‐3 and 2020 US net prices, while costs for complications were based on published literature. Lifetime costs ($US) and quality‐adjusted life‐years (QALYs) were predicted and used to calculate incremental cost‐effectiveness ratio (ICER) estimates; extensive scenario and sensitivity analyses were conducted. Results: Lifetime medical costs were estimated to be $353,441 and $352,858 for individuals receiving Gla‐300 and Gla‐100 respectively; insulin costs were $52,613 and $50,818. Gla‐300 was associated with a gain of 8.97 QALYs and 21.12 life‐years, while Gla‐100 was associated with a gain of 8.89 QALYs and 21.07 life‐years. This resulted in an ICER of $7522/QALY gained for Gla‐300 versus Gla‐100. Thus, Gla‐300 was cost‐effective versus Gla‐100 based on a willingness‐to‐pay threshold of $50,000/QALY. Compared with Gla‐100, Gla‐300 provided a net monetary benefit of $3290. Scenario and sensitivity analyses confirmed the robustness of the base case. Conclusion: Gla‐300 may be a cost‐effective treatment option versus Gla‐100 over a lifetime horizon for insulin‐naïve people in the United States with T2D inadequately controlled on OADs. [ABSTRACT FROM AUTHOR]

Aims: A cost‐effectiveness analysis was conducted to compare insulin glargine 300 U/mL (Gla‐300) versus insulin degludec 100 U/mL (IDeg‐100) in insulin‐naïve adults with type 2 diabetes (T2D) sub‐optimally controlled with oral anti‐diabetic drugs (OADs). Methods: The BRAVO diabetes model was used to assess costs and outcomes for once‐daily Gla‐300 versus once‐daily IDeg‐100 from a US healthcare sector perspective. Baseline clinical data were based on BRIGHT, a 24‐week, non‐inferiority, randomised control trial comparing Gla‐300 and IDeg‐100 in adults with T2D sub‐optimally controlled with OADs (with or without glucagon‐like peptide‐1 receptor agonists). Treatment costs were based on doses observed in BRIGHT as well as net prices. Costs associated with complications were based on published literature. Lifetime costs (US$) and quality‐adjusted life‐years (QALYs) were predicted and used to calculate incremental cost‐effectiveness ratio estimates; extensive scenario and sensitivity analyses were conducted. Results: Overall lifetime medical costs were estimated to be $327,904 and $330,154 for people receiving Gla‐300 and IDeg‐100, respectively; insulin costs were $43,477 and $44,367, respectively. People receiving Gla‐300 gained 8.024 QALYs and 18.55 life‐years, while people receiving IDeg‐100 gained 7.997 QALYs and 18.52 life‐years. Because Gla‐300 was associated with a cost‐saving of $2250 and 0.027 additional QALYs, it was considered to be dominant compared with IDeg‐100. Results of the scenario and sensitivity analyses confirmed the robustness of the base case results. Conclusion: Gla‐300 was the dominant treatment option compared with IDeg‐100 based on the willingness‐to‐pay threshold of $50,000/QALY. Results remained robust against a wide range of alternative assumptions on key parameters. [ABSTRACT FROM AUTHOR]

People with type 2 diabetes receiving a second-generation basal insulin (BI) analog may be switched to a first-generation formulation for financial reasons or changes in health insurance. However, because second-generation BI analogs have more even pharmacokinetic profiles, longer durations of action (>24 vs. ≤24 hours), and more stable action profiles than first-generation BI analogs, such a change may result in suboptimal treatment persistence and/or adherence. This study compared treatment persistence, treatment adherence, rates of hypoglycemia, and health care resource utilization outcomes in people with type 2 diabetes who either continued treatment with the second-generation BI Gla-300 or switched to a first-generation BI. The study showed that continuing with Gla-300 was associated with a lower risk of discontinuing therapy, fewer emergency department visits, and lower hypoglycemia event rates than switching to a first-generation BI. [ABSTRACT FROM AUTHOR]

Aims: To provide real‐world data on the addition of basal insulin (BI) in people with type 2 diabetes mellitus (PWD2) suboptimally controlled with glucagon‐like peptide‐1 receptor agonist (GLP‐1RA) therapy. However, real‐world data on the addition of BI to GLP‐1RA therapy are limited. Materials and Methods: We used a US electronic medical record data source (IBM® Explorys®) that includes approximately 4 million PWD2 to assess the real‐world impact of adding the second‐generation BI analogue insulin glargine 300 U/mL (Gla‐300) to GLP‐1RA therapy. Insulin‐naïve PWD2 receiving GLP‐1RAs who also received Gla‐300 between March 1, 2015 and September 30, 2019 were identified; participants were required to have data for ≥12 months before, and ≥6 months after, addition of Gla‐300. Results: The mean (standard deviation [SD]) age of participants (N = 271) was 57.9 (10.8) years. Baseline glycated haemoglobin (HbA1c) was 9.16% and was significantly reduced (−0.97 [SD 1.60]%; P < 0.0001) after addition of Gla‐300; a significant increase in the proportion of PWD2 achieving HbA1c control was observed after addition of Gla‐300 (HbA1c <7.0%: 4.80% vs. 22.14%, P < 0.0001; HbA1c <8.0%: 19.56% vs. 51.29%, P < 0.0001). The incidence of overall (8.49% vs. 9.59%; P = 0.513) and inpatient/emergency department (ED)‐associated hypoglycaemia (0.37% vs. 0.74%; P = 1.000), as well as overall (0.33 vs. 0.46 per person per year [PPPY]; P = 0.170) and inpatient/ED‐associated hypoglycaemia events (0.01 vs. 0.04 PPPY; P = 0.466) were similar before and after addition of Gla‐300. Conclusions: In US real‐world clinical practice, adding Gla‐300 to GLP‐1RA significantly improved glycaemic control without significantly increasing hypoglycaemia in PWD2. Further research into the effect of adding Gla‐300 to GLP‐1RA therapy is warranted. [ABSTRACT FROM AUTHOR]

Aims: To compare the safety and efficacy of insulin glargine 300 U/mL (Gla-300) versus first-generation standard-of-care basal insulin analogues (SOC-BI; insulin glargine 100 U/mL or insulin detemir) at 6 months. Methods: In the 12-month, open-label, multicentre, randomized, pragmatic ACHIEVE Control trial, insulin-naïve adults with type 2 diabetes (T2D) and glycated haemoglobin (HbA1c) 64 to 97 mmol/mol (8.0%-11.0%) after ≥1 year of treatment with ≥2 diabetes medications were randomized to Gla-300 or SOC-BI. The composite primary endpoint, evaluated at 6 months, was the proportion of participants achieving individualized HbA1c targets per Healthcare Effectiveness Data and Information Set (HEDIS) criteria without documented symptomatic (blood glucose ≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia at any time of the day at 6 months. Results: Of 1651 and 1653 participants randomized to Gla-300 and SOC-BI, respectively, 31.3% and 27.9% achieved the composite primary endpoint at 6 months (odds ratio [OR] 1.19, 95% confidence interval [CI] 1.01-1.39; P = 0.03 for superiority); 78.4% and 75.3% had no documented symptomatic or severe hypoglycaemia (OR 1.19, 95% CI 1.01-1.41). Changes from baseline to month 6 in HbA1c, fasting plasma glucose, weight, and BI analogue dose were similar between groups. Conclusions: Among insulin-naïve adults with poorly controlled T2D, Gla-300 was associated with a statistically significantly higher proportion of participants achieving individualized HEDIS HbA1c targets without documented symptomatic or severe hypoglycaemia (vs SOC-BI) in a real-life population managed in a usual-care setting. The ACHIEVE Control study results add value to treatment decisions and options for patients, healthcare providers, payers and decision makers. [ABSTRACT FROM AUTHOR]

Aim: To report the effectiveness and safety of insulin glargine 300 U/mL (Gla-300) versus standard-of-care basal insulin analogues (SOC-BI) at 12 months in the ACHIEVE Control trial, which is a prospective pragmatic randomized real-life study in insulin-naïve adults with type 2 diabetes (T2D). Methods: A total of 3304 insulin-naïve adults with T2D and glycated haemoglobin (HbA1c) concentration of 64 to 97 mmol/mol (8.0% to 11.0%) after ≥1 year of treatment with two or more antihyperglycaemic agents were randomized to Gla-300 or SOC-BI. Key secondary endpoints included HbA1c target attainment without documented symptomatic (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia at 12 months. Results: At 12 months, 26.1% (Gla-300) and 23.7% (SOC-BI) of adults achieved HbA1c targets without documented symptomatic (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia (odds ratio [OR] 1.14, 95% confidence interval [CI] 0.97-1.35); 33.0% and 29.5%, respectively, achieved HbA1c targets without documented symptomatic (<3.0 mmol/L [<54 mg/dL]) or severe hypoglycaemia (OR 1.19, 95% CI 1.02-1.38). The OR for HbA1c target achievement was 1.15 (95% CI 0.99-1.34), and favoured Gla-300 versus SOC-BI for absence of documented symptomatic or severe hypoglycaemia at 12 months for both ≤3.9 mmol/L (≤70 mg/dL; OR 1.21, 95% CI 1.05-1.40) and < 3.0 mmol/L (<54 mg/dL; OR 1.26, 95% CI 1.07-1.48). Conclusion: Gla-300 tended to be associated with lower hypoglycaemia risk than SOC-BI in real-world clinical practice during the 12-month follow-up. [ABSTRACT FROM AUTHOR]

Aims: To better understand outcomes in people with type 2 diabetes at high risk of hypoglycemia, we conducted post hoc analyses in subgroups of participants from the real-world ACHIEVE Control study (NCT02451137) with ≥1 hypoglycemia risk factor.Methods: Insulin-naive adults with type 2 diabetes and A1c ≥8% were randomized 1:1 to insulin glargine 300 U/mL (Gla-300) or standard-of-care basal insulin (SOC-BI). Participants had documented history of ≥1 risk factors for hypoglycemia: chronic kidney disease, cardiovascular disease, dementia or blindness, age ≥65 years, or history of hypoglycemia. Outcomes included individualized A1c target attainment without documented symptomatic hypoglycemia (blood glucose [BG] ≤3.9 mmol/L or <3.0 mmol/L) or severe hypoglycemia, A1c target attainment, and absence of documented symptomatic or severe hypoglycemia at 6 and 12 months.Results: Within subgroups, odds ratios generally showed trends favoring Gla-300 versus SOC-BI, particularly for hypoglycemia avoidance in participants ≥65 years of age (BG ≤3.9 mmol/L; odds ratio, 1.52; 95% confidence interval, 1.14-2.03) and those with chronic kidney disease (BG ≤3.9 mmol/L; odds ratio, 2.28; 95% confidence interval, 1.26-4.12). Results were consistent with the overall population.Conclusions: These data suggest potential benefit of Gla-300 versus SOC-BI for avoiding hypoglycemia in participants with ≥1 hypoglycemia risk factor. [ABSTRACT FROM AUTHOR]