A New Insulin Immunoassay Specific for the Rapid-Acting Insulin Analog, Insulin Aspart, Suitable for Bioavailability, Bioequivalence, and Pharmacokinetic Studies

Andersen, Lennart; Jørgensen, P. N.; Jensen, Lisbeth Bjerring; Walsh, Declan

doi:10.1016/s0009-9120(00)00183-1

Cited by 62 publications

(44 citation statements)

References 9 publications

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“…The insulin assay measures human insulin (endogenous insulin and NPH insulin) but not insulin aspart. Insulin aspart was measured with a modification of the method described by Andersen et al [24]. Total insulin concentrations in the aspart group were calculated as the sum of human insulin and insulin aspart [25].…”

Section: Different Insulin Regimens and Postprandial Arterial Wall Dymentioning

confidence: 99%

Effects of Mealtime Insulin Aspart and Bedtime NPH Insulin on Postprandial Inflammation and Endothelial Cell Function in Patients with Type 2 Diabetes

Bladbjerg

Henriksen

Akram

et al. 2011

Basic &Amp; Clinical Pharmacology &Amp; Toxicology

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Acute hyperglycaemia exerts deleterious effects on the arterial wall. We suggested that rapid-acting insulin has a beneficial postprandial effect on endothelial dysfunction and inflammation compared with intermediate-acting insulin because of its ability to lower postprandial hyperglycaemia. This was tested in a parallel, controlled study on well-controlled patients with type 2 diabetes randomly assigned to bedtime Neutral Protamine Hagedorn (NPH) insulin (n = 41) or mealtime insulin aspart (n = 37). They were served standard diabetic meals for breakfast (8.00) and lunch (12.00). Blood samples were collected at 7.40 (fasting), 9.30, 11.30, 13.30 and 15.30 and analysed for glucose, insulin, lipids, intercellular adhesion molecules (ICAM), C-reactive protein (CRP), von Willebrand factor (vWF) and fibrinogen. The postprandial glucose response differed significantly between insulin regimens with a postprandial increase on NPH insulin and a decrease on insulin aspart. There was a minor but significant postprandial decrease in ICAM, CRP and vWF on both insulin regimens and a decrease in fibrinogen on NPH insulin. No insulin group differences were observed in postprandial responses for ICAM, CRP, vWF and fibrinogen. The rapid-acting insulin analogue aspart and the intermediate-acting insulin NPH had different effects on postprandial glucose response but similar postprandial effects on markers of inflammation and endothelial dysfunction.Type 2 diabetes is associated with increased risk of cardiovascular disease [1]. There is a strong relationship between postprandial hyperglycaemia and the risk of cardiovascular disease in epidemiological studies where postprandial hyperglycaemia is more important than fasting blood glucose or HbA1c as predictors [2][3][4][5]. However, this concept has recently been challenged [6,7] and is still highly debated [8,9].Experimental data indicate that acute hyperglycaemia can exert deleterious effects on the arterial wall measured as flow-mediated vasodilatation [10][11][12]. In line with this, the link between acute hyperglycaemia and inflammation and endothelial cell dysfunction has been investigated, showing an acute increase in interleukin 6 (IL-6) and tumour necrosis factor alfa (TNFa) [ [21] or by the antioxidant glutathione [13,14]. In these studies, the hypoglycaemic agent was compared with placebo, and different treatment regimens have not been compared. It is assumed that pharmacological agents directed towards postprandial hyperglycaemia will be more effective in reducing postprandial inflammation and endothelial cell dysfunction than treatment directed towards fasting hyperglycaemia.The aim of this short-term study in well-controlled patients with type 2 diabetes was to compare the acute effect of two different insulin treatment regimens on postprandial inflammation and endothelial cell function evaluated by biochemical markers. We suggested that the rapid-acting insulin analogue insulin aspart, directed towards postprandial hyperglycaemia, has a beneficial postprandi...

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Section: Different Insulin Regimens and Postprandial Arterial Wall Dymentioning

confidence: 99%

Effects of Mealtime Insulin Aspart and Bedtime NPH Insulin on Postprandial Inflammation and Endothelial Cell Function in Patients with Type 2 Diabetes

Bladbjerg

Henriksen

Akram

et al. 2011

Basic &Amp; Clinical Pharmacology &Amp; Toxicology

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“…Peptides Monoclonal antibodies to human insulin (HUI-081) and insulin aspart (X14-6F34) and insulin aspart standards were kindly provided by L Andersen (Department of Immunochemistry, Novo Nordisk A/S) (14). HUI-081 was employed as coating antibody (3 mg/l).…”

Section: Free and Total Insulin Aspart Measurements In Serummentioning

confidence: 99%

“…Accordingly, after lyophilisation, buffers C and D (300 ml/sample) were added for free and total insulin aspart determinations respectively. Afterward, insulin aspart was measured by a sandwich assay as described by Andersen et al (14), except that the detecting antibody was europium labelled (timeresolved immunofluorometric assay (TR-IMFA)).…”

Section: Gel Separation Proceduresmentioning

confidence: 99%

Impact of insulin antibodies on insulin aspart pharmacokinetics and pharmacodynamics after 12-week treatment with multiple daily injections of biphasic insulin aspart 30 in patients with type 1 diabetes

Jw¹,

Frystyk²,

Lauritzen³

et al. 2005

eur j endocrinol

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Objective: This study aimed to evaluate the impact of insulin antibodies on insulin aspart pharmacokinetics and pharmacodynamics after 12-week multiple daily injections of biphasic insulin aspart 30 (30% fast-acting and 70% protamine-crystallised insulin aspart, BIAsp30) in patients with type 1 diabetes. Methods: Twenty-three patients (8 women, 15 men) aged 44.8 (20.6-62.5) years (median and range) with diabetes duration of 19.5 (1.6 -44.6) years and haemoglobin (Hb)A 1C of 9.2% (8.1-12.3%) participated in the study, which consisted of 12-week treatment with multiple injections of BIAsp30. At the end of the treatment period, all patients attended two 24-h profile days 1 week apart for pharmacokinetic and pharmacodynamic assessments. HbA 1C and insulin antibodies were also determined. Results: Patients were stratified into two groups depending on whether the level of insulin binding to insulin antibodies was below or above 75% (moderate vs high (%, median and range): 62 (15 -74) vs 80 (75 -89)). High levels of insulin antibodies resulted in about threefold increase in AUC (0 -24 h) (the area under the concentration-time curve during 24 h) for total insulin aspart (analysis of variance, P , 0.05). The differences in free insulin aspart pharmacokinetics, insulin pharmacodynamics and HbA 1C were not statistically significant between patients with different levels of insulin antibodies. Total daily insulin dosage was significantly lower in patients with high than moderate levels of insulin antibodies. Conclusions: In type 1 diabetic patients, high levels of circulating insulin antibodies result in elevated total, but not free, insulin aspart profiles. Consistent with the finding of similar insulin pharmacodynamics, the long-term glycaemic control is not significantly different between patients with different levels of insulin antibodies. 153 907-913 European Journal of Endocrinology

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“…This assay is appropriate for measurements of IAsp at physiological concentrations (0-1,000 pmol/l) without crossreactivity with HI. The total coefficient of variation for this assay is 14.7% [7] and the detection limit is 5.3 pmol/l; levels below this value were set to zero. Insulin assays measured total insulin.…”

Section: Methodsmentioning

confidence: 99%

Evaluation of insulin antibodies and placental transfer of insulin aspart in pregnant women with type 1 diabetes mellitus

et al. 2008

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A New Insulin Immunoassay Specific for the Rapid-Acting Insulin Analog, Insulin Aspart, Suitable for Bioavailability, Bioequivalence, and Pharmacokinetic Studies

Cited by 62 publications

References 9 publications

Effects of Mealtime Insulin Aspart and Bedtime NPH Insulin on Postprandial Inflammation and Endothelial Cell Function in Patients with Type 2 Diabetes

Effects of Mealtime Insulin Aspart and Bedtime NPH Insulin on Postprandial Inflammation and Endothelial Cell Function in Patients with Type 2 Diabetes

Impact of insulin antibodies on insulin aspart pharmacokinetics and pharmacodynamics after 12-week treatment with multiple daily injections of biphasic insulin aspart 30 in patients with type 1 diabetes

Evaluation of insulin antibodies and placental transfer of insulin aspart in pregnant women with type 1 diabetes mellitus

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