Comparison of the pharmacokinetics and pharmacodynamics of biphasic insulin aspart and insulin glargine in people with type 2 diabetes

Luzio, Stephen Denis; Dunseath, Gareth; Peter, Rajesh; Pauvaday, Vassen; Owens, David R.

doi:10.1007/s00125-006-0243-2

Cited by 58 publications

(54 citation statements)

References 15 publications

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“…1). This action profile is remarkably in line with previous reports (15)(16)(17) in which glargine PD was studied after morning injection. In contrast, with evening glargine the distribution of the metabolic effect was quite different.…”

Section: Discussionsupporting

confidence: 92%

“…Distribution of the metabolic effect may be quite different if the insulin to be studied is injected in the morning compared with the evening. Therefore, it would not be correct to assume that the greater metabolic activity of glargine, observed 6-8 h after morning dosing (15)(16)(17), is representative of the true action profile since in the current study this appears quite different when glargine is administered in the evening.…”

Section: Discussionmentioning

confidence: 73%

“…Yet, an indirect comparison of PK and PD between studies, where glargine was given in the evening (14) compared with the morning (15)(16)(17), suggests important differences in action profiles, although in such a comparison the contribution of circadian changes in insulin sensitivity should be taken into account (18,19).…”

mentioning

confidence: 99%

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Pharmacokinetics and Pharmacodynamics of Insulin Glargine Given in the Evening as Compared With in the Morning in Type 2 Diabetes

et al. 2014

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OBJECTIVETo compare pharmacokinetics (PK) and pharmacodynamics (PD) of insulin glargine in type 2 diabetes mellitus (T2DM) after evening versus morning administration. RESEARCH DESIGN AND METHODSTen T2DM insulin-treated persons were studied during 24-h euglycemic glucose clamp, after glargine injection (0.4 units/kg s.c.), either in the evening (2200 h) or the morning (1000 h). RESULTSThe 24-h glucose infusion rate area under the curve (AUC 0-24h ) was similar in the evening and morning studies (1,058 6 571 and 995 6 691 mg/kg 3 24 h, P = 0.503), but the first 12 h (AUC 0-12h ) was lower with evening versus morning glargine (357 6 244 vs. 593 6 374 mg/kg 3 12 h, P = 0.004), whereas the opposite occurred for the second 12 h (AUC 12-24h 700 6 396 vs. 403 6 343 mg/kg 3 24 h, P = 0.002). The glucose infusion rate differences were totally accounted for by different rates of endogenous glucose production, not utilization. Plasma insulin and C-peptide levels did not differ in evening versus morning studies. Plasma glucagon levels (AUC 0-24h 1,533 6 656 vs. 1,120 6 344 ng/L/h, P = 0.027) and lipolysis (free fatty acid AUC 0-24h 7.5 6 1.6 vs. 8.9 6 1.9 mmol/L/h, P = 0.005; b-OH-butyrate AUC 0-24h 6.8 6 4.7 vs. 17.0 6 11.9 mmol/L/h, P = 0.005; glycerol, P < 0.020) were overall more suppressed after evening versus morning glargine administration. CONCLUSIONSThe PD of insulin glargine differs depending on time of administration. With morning administration insulin activity is greater in the first 0-12 h, while with evening administration the activity is greater in the 12-24 h period following dosing. However, glargine PK and plasma C-peptide levels were similar, as well as glargine PD when analyzed by 24-h clock time independent of the time of administration. Thus, the results reflect the impact of circadian changes in insulin sensitivity in T2DM (lower in the night-early morning vs. afternoon hours) rather than glargine per se.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 73%

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Pharmacokinetics and Pharmacodynamics of Insulin Glargine Given in the Evening as Compared With in the Morning in Type 2 Diabetes

et al. 2014

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“…It has been demonstrated that timeaction profiles for insulin glargine obtained in studies using healthy volunteers 9 did not reflect that of a study population of patients with Type 1 diabetes mellitus. 22,25 Furthermore, extended duration of action of insulin in healthy volunteers may be observed due to continuous endogenous insulin secretion. 25 The use of a study population of patients diagnosed with Type 1 diabetes mellitus is recommended, as endogenous insulin secretion will not affect results obtained.…”

Section: Resultsmentioning

confidence: 99%

“…Results from glucose clamp studies performed in healthy volunteers, 9,30 patients diagnosed with Type 1 diabetes mellitus 7,8,21 and Type 2 diabetes mellitus 22,23 have been published. However, for each population a number of potentially confounding factors must be considered when interpreting the results.…”

Section: Study Populationmentioning

confidence: 99%

A practical guide to the interpretation of PK/PD profiles of longer-acting analogue insulins. Part one: The principles of glucose clamp studies

Greeff

Tonder

Naidu

et al. 2018

Journal of Endocrinology, Metabolism and Diabetes of South Afri

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Glucose clamp studies are used to determine pharmacokinetics (PK) and pharmacodynamics (PD) of analogue insulins. With the development of longer-acting basal analogue insulins, including glargine 300 (Gla-300) and insulin degludec (IDeg), results from numerous glucose clamp studies are readily available. However, interpreting PK/PD profiles in a scientifically sound manner can be a challenging feat. This is the first in a series of publications that will suggest practical tips for interpreting and comparing results from glucose clamp studies. Variations in the glucose clamp methodology, duration of clamp studies and glucose clamp targets influence the study design and results significantly. Selection of study populations, including healthy patients or patients with Type 1 or 2 diabetes mellitus, has important implications. The dose of study insulin should reflect that of the general treatment population, and ideally steady-state conditions should be used. During the study the plasma insulin concentration and glucose infusion rate describe the pharmacokinetics and pharmacodynamics of the study insulin. With these practical tips in mind, results of glucose clamp studies can be interpreted in a scientifically correct manner. The next article in this series will discuss the interpretation of PK/PD profiles using two newly developed longer-acting basal analogue insulins: Gla-300 and IDeg.

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Current literature in diabetes

2006

Diabetes Metabolism Res

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In order to keep subscribers up‐to‐date with the latest developments in their field, John Wiley & Sons are providing a current awareness service in each issue of the journal. The bibliography contains newly published material in the field of diabetes/metabolism. Each bibliography is divided into 26 sections: 1 Reviews & Symposia; 2 General; 3 Genetics; 4 Epidemiology; 5 Immunology; 6 Obesity; 7 Prediction and Prevention; 8 Intervention: a) General; b) Care; c) Drug Therapy; d)Economics; e) Gene therapy; f) Nursing; g) Nutrition; h) Surgery; i) Transplantation; 9 Pathology and Complications: a) General; b) Cardiovascular; c) Eye disease; d) Gestational and fetal; e) Neurological; f) Podiatrical; g) Renal; 10 Endocrinology & Metabolism; 11 Experimental Studies; 12 Diagnosis and Techniques. Within each section, articles are listed in alphabetical order with respect to author

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Comparison of the pharmacokinetics and pharmacodynamics of biphasic insulin aspart and insulin glargine in people with type 2 diabetes

Cited by 58 publications

References 15 publications

Pharmacokinetics and Pharmacodynamics of Insulin Glargine Given in the Evening as Compared With in the Morning in Type 2 Diabetes

Pharmacokinetics and Pharmacodynamics of Insulin Glargine Given in the Evening as Compared With in the Morning in Type 2 Diabetes

A practical guide to the interpretation of PK/PD profiles of longer-acting analogue insulins. Part one: The principles of glucose clamp studies

Current literature in diabetes

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