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A Comparison of Pharmacokinetic and Pharmacodynamic Properties Between Faster-Acting Insulin Aspart and Insulin Aspart in Elderly Subjects with Type 1 Diabetes Mellitus.
Drugs Aging 2017; 34(1):29-38DA

Abstract

BACKGROUND

Due to population aging, an increasing number of elderly patients with diabetes use insulin. It is therefore important to investigate the characteristics of new insulins in this population. Faster-acting insulin aspart (faster aspart) is insulin aspart (IAsp) in a new formulation with faster absorption. This study investigated the pharmacological properties of faster aspart in elderly subjects with type 1 diabetes mellitus (T1DM).

METHODS

In a randomised, double-blind, two-period crossover trial, 30 elderly (≥65 years) and 37 younger adults (18-35 years) with T1DM received single subcutaneous faster aspart or IAsp dosing (0.2 U/kg) and underwent an euglycaemic clamp (target 5.5 mmol/L) for up to 12 h.

RESULTS

The pharmacokinetic and pharmacodynamic time profiles were left-shifted for faster aspart versus IAsp. In each age group, onset of appearance occurred approximately twice as fast (~3 min earlier) and early exposure (area under the concentration-time curve [AUC] for serum IAsp from time zero to 30 min [AUCIAsp,0-30 min]) was greater (by 86% in elderly and 67% in younger adults) for faster aspart than for IAsp. Likewise, onset of action occurred 10 min faster in the elderly and 9 min faster in younger adults, and early glucose-lowering effect (AUC for the glucose infusion rate [GIR] from time zero to 30 min [AUCGIR,0-30 min]) was greater (by 109%) for faster aspart than for IAsp in both age groups. Total exposure (AUCIAsp,0-t) and the maximum concentration (C max) for faster aspart were greater (by 30 and 28%, respectively) in elderly than in younger adults. No age group differences were seen for the total (AUCGIR,0-t) or maximum (GIRmax) glucose-lowering effect.

CONCLUSION

This study demonstrated that the ultra-fast pharmacological properties of faster aspart are similar in elderly subjects and younger adults with T1DM. ClinicalTrials.gov Identifier: NCT02003677.

Authors+Show Affiliations

Profil Institut für Stoffwechselforschung GmbH, Hellersbergstraβe 9, 41460, Neuss, Germany. tim.heise@profil.com.Profil Institut für Stoffwechselforschung GmbH, Hellersbergstraβe 9, 41460, Neuss, Germany.Profil Institut für Stoffwechselforschung GmbH, Hellersbergstraβe 9, 41460, Neuss, Germany.Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27873152

Citation

Heise, Tim, et al. "A Comparison of Pharmacokinetic and Pharmacodynamic Properties Between Faster-Acting Insulin Aspart and Insulin Aspart in Elderly Subjects With Type 1 Diabetes Mellitus." Drugs & Aging, vol. 34, no. 1, 2017, pp. 29-38.
Heise T, Hövelmann U, Zijlstra E, et al. A Comparison of Pharmacokinetic and Pharmacodynamic Properties Between Faster-Acting Insulin Aspart and Insulin Aspart in Elderly Subjects with Type 1 Diabetes Mellitus. Drugs Aging. 2017;34(1):29-38.
Heise, T., Hövelmann, U., Zijlstra, E., Stender-Petersen, K., Jacobsen, J. B., & Haahr, H. (2017). A Comparison of Pharmacokinetic and Pharmacodynamic Properties Between Faster-Acting Insulin Aspart and Insulin Aspart in Elderly Subjects with Type 1 Diabetes Mellitus. Drugs & Aging, 34(1), pp. 29-38. doi:10.1007/s40266-016-0418-6.
Heise T, et al. A Comparison of Pharmacokinetic and Pharmacodynamic Properties Between Faster-Acting Insulin Aspart and Insulin Aspart in Elderly Subjects With Type 1 Diabetes Mellitus. Drugs Aging. 2017;34(1):29-38. PubMed PMID: 27873152.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Comparison of Pharmacokinetic and Pharmacodynamic Properties Between Faster-Acting Insulin Aspart and Insulin Aspart in Elderly Subjects with Type 1 Diabetes Mellitus. AU - Heise,Tim, AU - Hövelmann,Ulrike, AU - Zijlstra,Eric, AU - Stender-Petersen,Kirstine, AU - Jacobsen,Jacob Bonde, AU - Haahr,Hanne, PY - 2016/11/23/pubmed PY - 2017/8/22/medline PY - 2016/11/23/entrez SP - 29 EP - 38 JF - Drugs & aging JO - Drugs Aging VL - 34 IS - 1 N2 - BACKGROUND: Due to population aging, an increasing number of elderly patients with diabetes use insulin. It is therefore important to investigate the characteristics of new insulins in this population. Faster-acting insulin aspart (faster aspart) is insulin aspart (IAsp) in a new formulation with faster absorption. This study investigated the pharmacological properties of faster aspart in elderly subjects with type 1 diabetes mellitus (T1DM). METHODS: In a randomised, double-blind, two-period crossover trial, 30 elderly (≥65 years) and 37 younger adults (18-35 years) with T1DM received single subcutaneous faster aspart or IAsp dosing (0.2 U/kg) and underwent an euglycaemic clamp (target 5.5 mmol/L) for up to 12 h. RESULTS: The pharmacokinetic and pharmacodynamic time profiles were left-shifted for faster aspart versus IAsp. In each age group, onset of appearance occurred approximately twice as fast (~3 min earlier) and early exposure (area under the concentration-time curve [AUC] for serum IAsp from time zero to 30 min [AUCIAsp,0-30 min]) was greater (by 86% in elderly and 67% in younger adults) for faster aspart than for IAsp. Likewise, onset of action occurred 10 min faster in the elderly and 9 min faster in younger adults, and early glucose-lowering effect (AUC for the glucose infusion rate [GIR] from time zero to 30 min [AUCGIR,0-30 min]) was greater (by 109%) for faster aspart than for IAsp in both age groups. Total exposure (AUCIAsp,0-t) and the maximum concentration (C max) for faster aspart were greater (by 30 and 28%, respectively) in elderly than in younger adults. No age group differences were seen for the total (AUCGIR,0-t) or maximum (GIRmax) glucose-lowering effect. CONCLUSION: This study demonstrated that the ultra-fast pharmacological properties of faster aspart are similar in elderly subjects and younger adults with T1DM. ClinicalTrials.gov Identifier: NCT02003677. SN - 1179-1969 UR - https://www.unboundmedicine.com/medline/citation/27873152/A_Comparison_of_Pharmacokinetic_and_Pharmacodynamic_Properties_Between_Faster_Acting_Insulin_Aspart_and_Insulin_Aspart_in_Elderly_Subjects_with_Type_1_Diabetes_Mellitus_ L2 - https://dx.doi.org/10.1007/s40266-016-0418-6 DB - PRIME DP - Unbound Medicine ER -