The Safety and Efficacy of Second-Generation Basal Insulin Analogues in Adults with Type 2 Diabetes at Risk of Hypoglycemia and Use in Other Special Populations: A Narrative Review

Cheng, Alice; Wong, Jencia; Freemantle, Nick; Acharya, Shamasunder; Ekinci, Elif I

doi:10.1007/s13300-020-00925-8

Cited by 19 publications

(20 citation statements)

References 91 publications

(250 reference statements)

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“…In summary, the sustained glycaemic benefits of Gla-300 in the older adult population, as well as its reduced risk of hypoglycaemia compared to first-generation basal insulin analogues, support its use in older adults with T2DM. In addition, the flexibility and convenience of a once-daily injection of Gla-300 is advantageous in this population who may rely on caretakers to administer insulin [ 38 ].…”

Section: Discussionmentioning

confidence: 99%

Impact of Age on the Effectiveness and Safety of Insulin Glargine 300 U/mL: Results from the REALI European Pooled Data Analysis

et al. 2021

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Introduction: Patients aged C 65 years continue to be underrepresented in clinical studies related to type 2 diabetes mellitus (T2DM). Accordingly, the REALI pooled analysis was performed to evaluate the effectiveness and safety of insulin glargine 300 U/mL (Gla-300) across different age subgroups, using data from 14 interventional and non-interventional studies. Methods: Pooled efficacy and safety data were collected from 8106 European patients with uncontrolled T2DM who were initiated on or switched to Gla-300 injected once daily for 24 weeks. Patients were categorised into five age subgroups: \ 50 (N = 727), 50-59 (N = 2030), 60-69 (N = 3054), 70-79 (N = 1847) and C 80 years (N = 448). Results: Mean baseline haemoglobin A1c (HbA1c) decreased linearly from the youngest (9.10%) to the oldest (8.46%) age subgroup. Following Gla-300 initiation, there were similar HbA1c reductions across age groups, with a least

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Section: Discussionmentioning

confidence: 99%

Impact of Age on the Effectiveness and Safety of Insulin Glargine 300 U/mL: Results from the REALI European Pooled Data Analysis

et al. 2021

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“…Overall, the findings of the REALI CKD pooled analysis, along with the data from the aforementioned post hoc analyses [ 8 , 9 ], support the use of Gla-300 in patients with renal impairment, given its sustained glycaemic control benefit and its overall low risk of hypoglycaemia in this challenging-to-treat population that is particularly vulnerable to hypoglycaemia. This vulnerability is due to multiple factors, including a reduced renal mass and therefore a reduced capacity for renal glucose release, especially when the eGFR falls below 45 mL/min/1.73 m 2 [ 4 , 7 , 21 ]. Hypoglycaemic events affect patients’ lives profoundly, as they are associated with psychological distress, cardiovascular morbidity, and a significantly increased risk of death within 1 day of a hypoglycaemic event [ 4 , 7 , 20 ].…”

Section: Discussionmentioning

confidence: 99%

Glycaemic Control with Insulin Glargine 300 U/mL in Individuals with Type 2 Diabetes and Chronic Kidney Disease: A REALI European Pooled Data Analysis

et al. 2021

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Introduction: Management of type 2 diabetes mellitus (T2DM) in patients with chronic kidney disease is complex. Using the REALI European pooled database, we determined the impact of baseline renal function on the effectiveness and safety of insulin glargine 300 U/mL (Gla-300) initiated in adults with inadequately controlled T2DM. Methods: Data from 1712 patients with available estimated glomerular filtration rate (eGFR) at baseline were pooled from six 24-week prospective studies. Patients who received once-daily subcutaneous injections of Gla-300 were classified into four renal function subgroups, according to baseline eGFR: C 90 (N = 599), 60-89 (N = 786), 45-59 (N = 219), and 15-44 mL/min/1.73 m 2 (N = 108). Results: Compared to those with baseline eGFR C 60 mL/min/1.73 m 2 , patients with lower eGFR values tended to be older, had a longer T2DM duration, and were more likely to present diabetic complications. After 24 weeks of Gla-300 therapy, the least-squares mean (95% confidence interval) decrease in haemoglobin A1c (HbA1c) from baseline (-1.14% [

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“…Sales of insulin degludec grew 1.8-fold in 2017 vs. 2016, rising to US$1.11 billion in 2017 ( 24 ). This increase has been supported by studies demonstrating the cost-effectiveness of degludec compared with other long-acting insulin analogues ( 25 – 28 ).…”

Section: Introductionmentioning

confidence: 89%

“…In addition, improving patient comfort and convenience ( 62 ). Published studies have shown that Gla-300 does improve glycaemic control alongside reducing the incidence of nocturnal hypoglycaemia vs. the 100 IU/ml formulation ( 25 , 62 – 65 ). However, some authors and health authorities are not convinced of the benefits of Gla-300 ( 66 ), and have restricted its prescribing vs. the 100 IU/ml formulation ( 67 ).…”

Section: Introductionmentioning

confidence: 99%

The Current Situation Regarding Long-Acting Insulin Analogues Including Biosimilars Among African, Asian, European, and South American Countries; Findings and Implications for the Future

Godman

Haque

Leong

et al. 2021

Front. Public Health

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Background: Diabetes mellitus rates continue to rise, which coupled with increasing costs of associated complications has appreciably increased global expenditure in recent years. The risk of complications are enhanced by poor glycaemic control including hypoglycaemia. Long-acting insulin analogues were developed to reduce hypoglycaemia and improve adherence. Their considerably higher costs though have impacted their funding and use. Biosimilars can help reduce medicine costs. However, their introduction has been affected by a number of factors. These include the originator company dropping its price as well as promoting patented higher strength 300 IU/ml insulin glargine. There can also be concerns with different devices between the manufacturers.Objective: To assess current utilisation rates for insulins, especially long-acting insulin analogues, and the rationale for patterns seen, across multiple countries to inform strategies to enhance future utilisation of long-acting insulin analogue biosimilars to benefit all key stakeholders.Our approach: Multiple approaches including assessing the utilisation, expenditure and prices of insulins, including biosimilar insulin glargine, across multiple continents and countries.Results: There was considerable variation in the use of long-acting insulin analogues as a percentage of all insulins prescribed and dispensed across countries and continents. This ranged from limited use of long-acting insulin analogues among African countries compared to routine funding and use across Europe in view of their perceived benefits. Increasing use was also seen among Asian countries including Bangladesh and India for similar reasons. However, concerns with costs and value limited their use across Africa, Brazil and Pakistan. There was though limited use of biosimilar insulin glargine 100 IU/ml compared with other recent biosimilars especially among European countries and Korea. This was principally driven by small price differences in reality between the originator and biosimilars coupled with increasing use of the patented 300 IU/ml formulation. A number of activities were identified to enhance future biosimilar use. These included only reimbursing biosimilar long-acting insulin analogues, introducing prescribing targets and increasing competition among manufacturers including stimulating local production.Conclusions: There are concerns with the availability and use of insulin glargine biosimilars despite lower costs. This can be addressed by multiple activities.

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The Safety and Efficacy of Second-Generation Basal Insulin Analogues in Adults with Type 2 Diabetes at Risk of Hypoglycemia and Use in Other Special Populations: A Narrative Review

Cited by 19 publications

References 91 publications

Impact of Age on the Effectiveness and Safety of Insulin Glargine 300 U/mL: Results from the REALI European Pooled Data Analysis

Impact of Age on the Effectiveness and Safety of Insulin Glargine 300 U/mL: Results from the REALI European Pooled Data Analysis

Glycaemic Control with Insulin Glargine 300 U/mL in Individuals with Type 2 Diabetes and Chronic Kidney Disease: A REALI European Pooled Data Analysis

The Current Situation Regarding Long-Acting Insulin Analogues Including Biosimilars Among African, Asian, European, and South American Countries; Findings and Implications for the Future

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