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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]

Video abstract: View a video abstract for this article. Aims: This multicentre (N = 104), randomized controlled phase 4 study compared the efficacy and safety of insulin glargine 300 units/mL (Gla‐300) with insulin glargine 100 units/mL (Gla‐100) in patients with type 1 diabetes (T1D). Materials and methods: Patients were randomized 1:1 to self‐perform morning Gla‐300 or Gla‐100 injections daily for 16 weeks. The primary endpoint was percentage of time blood glucose remained in the target range (70–180 mg/dL) during Week 15/16, measured by blinded continuous glucose monitoring. Secondary endpoints included incidence and rate of nocturnal symptomatic hypoglycaemia (≤70 mg/dL), glycaemic variability parameters and safety assessments. Exploratory analyses were performed in patients with glycated haemoglobin (HbA1c) <7.5% at Week 16. Results: Overall, 638 patients with T1D were included (Gla‐300, n = 320; Gla‐100, n = 318). In the modified intent‐to‐treat (mITT) population, no differences between Gla‐300 and Gla‐100 were observed in time in range, in glycaemic variability, or in incidence or rates of nocturnal symptomatic hypoglycaemia. In exploratory analyses of patients with HbA1c <7.5% at Week 16, Gla‐300 recipients had greater improvement in time in range over 24 hours, during the day and at night compared with Gla‐100 recipients (P < 0.05), with small increases in overall hypoglycaemia. Conclusions: Time in range and glycaemic variability were similar for Gla‐300 and Gla‐100 recipients at the end of study in the mITT population of relatively well‐controlled patients with T1D. In patients with end‐of‐study HbA1c <7.5%, exploratory analyses suggested that Gla‐300 provided improvements in time in range compared with Gla‐100. [ABSTRACT FROM AUTHOR]

The outside back cover image is based on the Original Article A pragmatic randomized clinical trial of insulin glargine 300 U/mL versus first‐generation basal insulin analogues in insulin‐naïve adults with type 2 diabetes: 6‐month outcomes of ACHIEVE Control by Luigi F. Meneghini et al., https://doi.org/10.1111/dom.14152. [ABSTRACT FROM AUTHOR]