Comparison of Insulin Aspart With Buffered Regular Insulin and Insulin Lispro in Continuous Subcutaneous Insulin Infusion

Bode, Bruce W.; Weinstein, Richard L.; Bell, David; McGill, Janet B.; Nadeau, Daniel A.; Raskin, Philip; Davidson, Jaime A.; Henry, Robert R.; Huang, Won Chin; Reinhardt, Rickey R.

doi:10.2337/diacare.25.3.439

Cited by 134 publications

(115 citation statements)

References 25 publications

(14 reference statements)

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“…The rates of major nocturnal hypoglycemic episodes or episodes of plasma glucose Յ36 mg/dl were very low in this study for both treatment groups, consistent with observations from an earlier CSII study in adults (18). Most hypoglycemic events occurred during the daytime, more consistent with the impact of daytime exercise/activity or inaccurate bolus dosing than with improper basal rate.…”

Section: Safetysupporting

confidence: 88%

“…In this study, the incidence of hyperglycemia for both treatment groups was lower (aspart,11%; lispro 17%) than in previous adult studies of insulin aspart CSII (18,26). However, the lower rate of hyperglycemic episodes in this study may be due to the fact that investigators had to report hyperglycemia as an adverse event and not merely as any instance when plasma glucose is Ͼ300 mg/dl.…”

Section: Safetycontrasting

confidence: 70%

“…Furthermore, it is unclear whether there are any notable differences in efficacy, safety, or tolerability between rapid-acting insulin analogs administered via CSII in children and adolescents. Although several studies have compared insulin analog CSII versus MDI therapy and insulin aspart versus insulin lispro CSII in adults (18,19), this is the first large study conducted to date to evaluate and compare the safety and efficacy of two analogs in CSII (insulin aspart versus insulin lispro) in children and adolescents with type 1 diabetes.…”

mentioning

confidence: 99%

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A Randomized Trial Comparing Continuous Subcutaneous Insulin Infusion of Insulin Aspart Versus Insulin Lispro in Children and Adolescents With Type 1 Diabetes

Weinzimer

Ternand²,

Howard³

et al. 2008

Diabetes Care

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OBJECTIVE -The safety and efficacy of insulin aspart continuous subcutaneous insulin infusion (CSII) was compared with that of insulin lispro CSII in children and adolescents with type 1 diabetes.RESEARCH DESIGN AND METHODS -Children and adolescents aged 4 -18 years with diagnosed type 1 diabetes Ն1 year previously and treated with insulin analog in a CSII Ն3 months were randomly assigned 2:1 to 16 weeks of insulin aspart CSII (n ϭ 198) or insulin lispro CSII (n ϭ 100) in this open-label, parallel-group, multicenter study. Standard diabetes safety and efficacy parameters were assessed.RESULTS -Baseline demographics, subject characteristics, and diabetes history were similar between treatment groups. After 16 weeks of treatment, insulin aspart CSII was noninferior to insulin lispro CSII as measured by change in A1C from baseline (aspart, Ϫ0.15 Ϯ 0.05%; lispro, Ϫ0.05 Ϯ 0.07% [95% CI of the treatment difference Ϫ0.27 to 0.07]; P ϭ 0.241). No significant differences between treatment groups were observed in fasting plasma glucose, hyperglycemia, and rates of hypoglycemic episodes. At week 16, 59.7% of subjects in the aspart group and 43.8% of subjects in the lispro groups achieved age-specific American Diabetes Association A1C goals (Ͻ8.5% for subjects aged Ͻ6 years; Ͻ8% for subjects aged 6 -18 years) (P ϭ 0.040, corrected for baseline). Daily insulin dose (units per kilogram) was significantly lower at week 16 for subjects treated with aspart compared with those treated with lispro (0.86 Ϯ 0.237 vs. 0.94 Ϯ 0.233, P ϭ 0.018).CONCLUSIONS -Insulin aspart was as safe and effective as insulin lispro for use in a CSII in children and adolescents with type 1 diabetes. Diabetes Care 31:210-215, 2008

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Section: Safetysupporting

confidence: 88%

Section: Safetycontrasting

confidence: 70%

mentioning

confidence: 99%

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A Randomized Trial Comparing Continuous Subcutaneous Insulin Infusion of Insulin Aspart Versus Insulin Lispro in Children and Adolescents With Type 1 Diabetes

Weinzimer

Ternand²,

Howard³

et al. 2008

Diabetes Care

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“…We ultimately identified 27 randomised controlled trials that compared SAI analogues with regular insulin using either CSII or IIT as injection regimens. Of these, 22 studies were performed with type 1 diabetic patients [5,6,7,10,11,12,14,15,16,38,39,40,41,42,43,44,45,46,47,48,49,50] and five studies had a combined study population of type 1 and type 2 diabetic patients [8,51,52,53,54]. Table 1 summarises the characteristics of the trials included in our analysis.…”

Section: Resultsmentioning

confidence: 99%

Meta-analysis of short-acting insulin analogues in adult patients with type 1 diabetes: continuous subcutaneous insulin infusion versus injection therapy

Siebenhofer¹,

Plank²,

Berghold

et al. 2004

Diabetologia

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Aims/hypothesis. This study aimed to compare the effect of treatment with short-acting insulin (SAI) analogues versus structurally unchanged short-acting insulin (regular insulin) on glycaemic control and on the risk of hypoglycaemic episodes in type 1 diabetic patients using different insulin treatment strategies. Methods. We performed a meta-analysis of 27 randomised controlled trials that compared the effect of SAI analogues with regular insulin in patients with type 1 diabetes mellitus. The treatments were administered either via continuous subcutaneous insulin infusion (CSII) or by conventional intensified insulin therapy (IIT) with short-acting insulin injections before meals and basal insulin administered once or twice daily in most cases. Results. HbA 1 c levels were reported for 20 studies. For studies using CSII, the weighted mean difference between values obtained using SAI analogues and regular insulin was −0.19% (95% CI: −0.27 to − 0.12), whereas the corresponding value for injection studies was −0.08% (95% CI: −0.15 to −0.02). For the analysis of overall hypoglycaemia, we used the results from nine studies that reported the mean frequency of hypoglycaemic episodes per patient per month. For studies using CSII, the standardised mean difference between SAI analogues and regular insulin was −0.07 (95% CI: −0.43 to 0.28), whereas for IIT studies the corresponding value was −0.04 (95% CI: −0.24 to 0.16). Conclusions/interpretation. Taking into consideration the low quality of the trials included, we can conclude that use of a short-acting insulin analogue in CSII therapy provides a small, but statistically significant improvement in glycaemic control compared with regular insulin. An even smaller effect was obtained with the use of ITT. The rate of overall hypoglycaemic episodes was not significantly reduced with short-acting insulin analogues in either injection regimen.

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“…Such issues are also affected by the excipients used in formulations 34. Normally these issues will be covered by a comment in the label/summary of product characteristics to the effect that pump use is appropriate.…”

Section: Insulin Devices: Pens and Pumpsmentioning

confidence: 99%

Biosimilar insulins: guidance for data interpretation by clinicians and users

Heinemann¹,

Home

Hompesch

2015

Diabetes Obesity Metabolism

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Biosimilar insulins are approved copies of insulins outside patent protection. Advantages may include greater market competition and potential cost reduction, but clinicians and users lack a clear perspective on ‘biosimilarity’ for insulins. The manufacturing processes for biosimilar insulins are manufacturer‐specific and, although these are reviewed by regulators there are few public data available to allow independent assessment or review of issues such as intrinsic quality or batch‐to‐batch variation. Preclinical measures used to assess biosimilarity, such as tissue and cellular studies of metabolic activity, physico‐chemical stability and animal studies of pharmacodynamics, pharmacokinetics and immunogenicity may be insufficiently sensitive to differences, and are often not formally published. Pharmacokinetic and pharmacodynamic studies (glucose clamps) with humans, although core assessments, have problems of precision which are relevant for accurate insulin dosing. Studies that assess clinical efficacy and safety and device compatibility are limited by current outcome measures, such as glycated haemoblobin levels and hypoglycaemia, which are insensitive to differences between insulins. To address these issues, we suggest that all comparative data are put in the public domain, and that systematic clinical studies are performed to address batch‐to‐batch variability, delivery devices, interchangeability in practice and long‐term efficacy and safety. Despite these challenges biosimilar insulins are a welcome addition to diabetes therapy and, with a transparent approach, should provide useful benefit to insulin users.

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Comparison of Insulin Aspart With Buffered Regular Insulin and Insulin Lispro in Continuous Subcutaneous Insulin Infusion

Cited by 134 publications

References 25 publications

A Randomized Trial Comparing Continuous Subcutaneous Insulin Infusion of Insulin Aspart Versus Insulin Lispro in Children and Adolescents With Type 1 Diabetes

A Randomized Trial Comparing Continuous Subcutaneous Insulin Infusion of Insulin Aspart Versus Insulin Lispro in Children and Adolescents With Type 1 Diabetes

Meta-analysis of short-acting insulin analogues in adult patients with type 1 diabetes: continuous subcutaneous insulin infusion versus injection therapy

Biosimilar insulins: guidance for data interpretation by clinicians and users

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