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Pharmacological properties of faster-acting insulin aspart vs insulin aspart in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion: A randomized, double-blind, crossover trial.
Diabetes Obes Metab 2017; 19(2):208-215DO

Abstract

AIM

To evaluate the pharmacological characteristics of faster-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp) during continuous subcutaneous insulin infusion (CSII).

METHODS

In this randomized, double-blind, crossover trial, 48 men and women aged 18 to 64 years with type 1 diabetes mellitus (T1DM) received faster aspart and IAsp as a 0.15 U/kg bolus dose via CSII, on top of a basal rate (0.02 U/kg/h), in a glucose clamp setting (target 5.5 mmol/L).

RESULTS

After a CSII bolus dose, the pharmacokinetic/pharmacodynamic profiles for faster aspart were left-shifted compared with those for IAsp. For faster aspart vs IAsp, the early glucose-lowering effect (area under the curve for glucose infusion rate [GIR]0-30min) was approximately 2-fold higher (least squares means 24.9 vs 11.4 mg/kg; estimated ratio faster aspart/IAsp 2.18, 95% confidence interval [CI] [1.33; 5.04]; P = .002), onset of glucose-lowering effect (time to early 50% of maximum GIR) occurred 11.1 minutes earlier (41.1 vs 52.3 minutes; 95% CI faster aspart - IAsp [-15.4; -6.9]; P<.001), and offset of glucose-lowering effect (time to late 50% of maximum GIR) occurred 24.0 minutes earlier (214.7 vs 238.7 minutes; 95% CI [-38.9; -9.1]; P=.002). Likewise, significantly greater early exposure and significantly earlier onset and offset of exposure were observed for faster aspart vs IAsp. Faster aspart and IAsp were both well tolerated.

CONCLUSIONS

In patients with T1DM using CSII, faster aspart better mimics the endogenous prandial insulin secretion and action than does IAsp. Faster aspart therefore has the potential to provide clinical benefits over current rapid-acting insulins in the insulin pump setting.

Authors+Show Affiliations

Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany.Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany.Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany.Novo Nordisk A/S, Søborg, Denmark.Novo Nordisk A/S, Søborg, Denmark.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27709762

Citation

Heise, Tim, et al. "Pharmacological Properties of Faster-acting Insulin Aspart Vs Insulin Aspart in Patients With Type 1 Diabetes Receiving Continuous Subcutaneous Insulin Infusion: a Randomized, Double-blind, Crossover Trial." Diabetes, Obesity & Metabolism, vol. 19, no. 2, 2017, pp. 208-215.
Heise T, Zijlstra E, Nosek L, et al. Pharmacological properties of faster-acting insulin aspart vs insulin aspart in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion: A randomized, double-blind, crossover trial. Diabetes Obes Metab. 2017;19(2):208-215.
Heise, T., Zijlstra, E., Nosek, L., Rikte, T., & Haahr, H. (2017). Pharmacological properties of faster-acting insulin aspart vs insulin aspart in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion: A randomized, double-blind, crossover trial. Diabetes, Obesity & Metabolism, 19(2), pp. 208-215. doi:10.1111/dom.12803.
Heise T, et al. Pharmacological Properties of Faster-acting Insulin Aspart Vs Insulin Aspart in Patients With Type 1 Diabetes Receiving Continuous Subcutaneous Insulin Infusion: a Randomized, Double-blind, Crossover Trial. Diabetes Obes Metab. 2017;19(2):208-215. PubMed PMID: 27709762.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmacological properties of faster-acting insulin aspart vs insulin aspart in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion: A randomized, double-blind, crossover trial. AU - Heise,Tim, AU - Zijlstra,Eric, AU - Nosek,Leszek, AU - Rikte,Tord, AU - Haahr,Hanne, Y1 - 2016/11/14/ PY - 2016/07/06/received PY - 2016/09/24/revised PY - 2016/09/28/accepted PY - 2016/10/7/pubmed PY - 2017/11/2/medline PY - 2016/10/7/entrez KW - insulin pump therapy KW - pharmacodynamics KW - pharmacokinetics KW - type 1 diabetes SP - 208 EP - 215 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 19 IS - 2 N2 - AIM: To evaluate the pharmacological characteristics of faster-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp) during continuous subcutaneous insulin infusion (CSII). METHODS: In this randomized, double-blind, crossover trial, 48 men and women aged 18 to 64 years with type 1 diabetes mellitus (T1DM) received faster aspart and IAsp as a 0.15 U/kg bolus dose via CSII, on top of a basal rate (0.02 U/kg/h), in a glucose clamp setting (target 5.5 mmol/L). RESULTS: After a CSII bolus dose, the pharmacokinetic/pharmacodynamic profiles for faster aspart were left-shifted compared with those for IAsp. For faster aspart vs IAsp, the early glucose-lowering effect (area under the curve for glucose infusion rate [GIR]0-30min) was approximately 2-fold higher (least squares means 24.9 vs 11.4 mg/kg; estimated ratio faster aspart/IAsp 2.18, 95% confidence interval [CI] [1.33; 5.04]; P = .002), onset of glucose-lowering effect (time to early 50% of maximum GIR) occurred 11.1 minutes earlier (41.1 vs 52.3 minutes; 95% CI faster aspart - IAsp [-15.4; -6.9]; P<.001), and offset of glucose-lowering effect (time to late 50% of maximum GIR) occurred 24.0 minutes earlier (214.7 vs 238.7 minutes; 95% CI [-38.9; -9.1]; P=.002). Likewise, significantly greater early exposure and significantly earlier onset and offset of exposure were observed for faster aspart vs IAsp. Faster aspart and IAsp were both well tolerated. CONCLUSIONS: In patients with T1DM using CSII, faster aspart better mimics the endogenous prandial insulin secretion and action than does IAsp. Faster aspart therefore has the potential to provide clinical benefits over current rapid-acting insulins in the insulin pump setting. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/27709762/Pharmacological_properties_of_faster_acting_insulin_aspart_vs_insulin_aspart_in_patients_with_type_1_diabetes_receiving_continuous_subcutaneous_insulin_infusion:_A_randomized_double_blind_crossover_trial_ L2 - https://doi.org/10.1111/dom.12803 DB - PRIME DP - Unbound Medicine ER -