insulin aspart

Insulin aspart is indicated to improve glycemic control in people with diabetes.

The onset of action is approximately fifteen minutes, the peak action is reached in 45–90 minutes, and the duration is 3–5 hours.

The safety of insulin aspart in people with diabetes is no different from that of regular insulin. The side effects that are commonly associated with insulin therapy include: allergic reactions, injection site irritation, rashes, and hypoglycemia. The most common side effect is hypoglycemia. Long-term use of insulin, including insulin aspart, can cause lipodystrophy at the site of repeated injections or infusion. To reduce the risk of lipodystrophy, rotate the injection sites within the same region. Weight gain can also occur with the use of insulin aspart and it has been attributed to anabolic effects of insulin and a decrease in glucosuria. Use of insulin aspart has also been associated with sodium retention and edema.{{Cite web |date=2025-02-17 |title=FDA Approves First Insulin Aspart Biosimilar |url=https://www.centerforbiosimilars.com/view/fda-approves-first-insulin-aspart-biosimilar |access-date=2025-02-19 |website=Center for Biosimilars |language=en}}

Insulin aspart can be used in an insulin pump and insulin pen for subcutaneous injection. Additionally, it can be used with an injection port such as the I-port.{{cite web|url=https://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a605013.html |title=Aspart insulin (rDNA origin) injection |access-date=8 June 2007 |archive-url=https://web.archive.org/web/20070610074313/http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a605013.html |archive-date=10 June 2007 |url-status=dead }}

Insulin aspart has a more rapid onset, and a shorter duration of activity than normal human insulin.{{cite web |url=https://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4254b_13_04_KP%20InsulinAspartFDAlabel102005.pdf |title=Novolog: insulin aspart |website=Food and Drug Administration |access-date=16 December 2019 |archive-date=17 May 2017 |archive-url=https://web.archive.org/web/20170517041656/https://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4254b_13_04_KP%20InsulinAspartFDAlabel102005.pdf |url-status=live }} Insulin aspart can also be used with external insulin pumps.

File:NovoLog- insulin aspart injection.pdf

Novolog Mix 70/30 is a product which contains 30% insulin aspart and 70% insulin aspart protamine. The insulin aspart protamine portion is a crystalline form of insulin aspart, which delays the action of the insulin, giving it a prolonged absorption profile after injection. The combination of the fast-acting form and the long-acting form allows the patient to receive fewer injections over the course of the day.{{cite web | work = Rx List | title = NovoLog Mix 70/30 | date = 6 August 2008 | url = http://www.rxlist.com/novolog-mix-70-30-drug.htm | archive-url = https://web.archive.org/web/20090420190334/http://www.rxlist.com/novolog-mix-70-30-drug.htm | archive-date = 20 April 2009 }}

Novolog Mix is marketed to be used with the Novo Nordisk Flexpen. The onset of action is less than 30 minutes, the peak action is reached in 1–4 hours, and the duration is less than 24 hours.{{cite book | vauthors = Beals JM, DeFelippis MR, Kovach PM | chapter = Insulin | veditors = Crommelin DJ, Sindelar RD, Meibohm B | date = 2008 | title = Pharmaceutical Biotechnology: Fundamentals and Applications. | location = New York, NY | publisher = Informa Healthcare USA, Inc. | page = 265–280 (270) | isbn = 978-1-4200-4437-9 }} NovoLog Mix is marketed in some countries as NovoMix 30.{{cite web | title=NovoMix 30 FlexPen 100 units/ml - Summary of Product Characteristics (SmPC) | website=(emc) | date=27 March 2019 | url=https://www.medicines.org.uk/emc/product/1600/smpc | access-date=12 April 2020 | archive-date=13 April 2020 | archive-url=https://web.archive.org/web/20200413050707/https://www.medicines.org.uk/emc/product/1600/smpc | url-status=live }}{{cite web | title=NovoMix EPAR | website=European Medicines Agency (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/novomix | access-date=12 April 2020 | archive-date=13 April 2020 | archive-url=https://web.archive.org/web/20200413050741/https://www.ema.europa.eu/en/medicines/human/EPAR/novomix | url-status=live }}

NovoRapid is produced in Saccharomyces cerevisiae by recombinant DNA technology.{{cite web | title=NovoRapid 100 units/ml in a vial - Summary of Product Characteristics (SmPC) | website=(emc) | date=25 May 2018 | url=https://www.medicines.org.uk/emc/product/7919/smpc | access-date=9 September 2020 | archive-date=16 January 2021 | archive-url=https://web.archive.org/web/20210116143931/https://www.medicines.org.uk/emc/product/7919/smpc | url-status=live }}

A faster acting version of aspart insulin, known as fast-aspart (Fiasp) insulin, is associated with more efficient control of post-prandial rise in blood glucose, without increasing the risks of hypoglycemia and glycemic variability.{{cite journal | vauthors = Dutta D, Mohindra R, Mahajan K, Sharma M | title = Performance of Fast-Acting Aspart Insulin as Compared to Aspart Insulin in Insulin Pump for Managing Type 1 Diabetes Mellitus: A Meta-Analysis | journal = Diabetes & Metabolism Journal | volume = 47 | issue = 1 | pages = 72–81 | date = January 2023 | pmid = 35746893 | pmc = 9925142 | doi = 10.4093/dmj.2022.0035 }}{{cite journal | vauthors = Evans M, Ceriello A, Danne T, De Block C, DeVries JH, Lind M, Mathieu C, Nørgaard K, Renard E, Wilmot EG | title = Use of fast-acting insulin aspart in insulin pump therapy in clinical practice | journal = Diabetes, Obesity & Metabolism | volume = 21 | issue = 9 | pages = 2039–2047 | date = September 2019 | pmid = 31144428 | pmc = 6773364 | doi = 10.1111/dom.13798 }}{{cite journal | vauthors = Evans M, Wilkinson M, Giannpolou A | title = Fast-Acting Insulin Aspart: The Rationale for a New Mealtime Insulin | journal = Diabetes Therapy | volume = 10 | issue = 5 | pages = 1793–1800 | date = October 2019 | pmid = 31485918 | pmc = 6778592 | doi = 10.1007/s13300-019-00685-0 }}

In December 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Kixelle, intended for the treatment of diabetes.{{cite web | title=Kixelle: Pending EC decision | website=European Medicines Agency (EMA) | date=10 December 2020 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/kixelle | access-date=12 December 2020 | archive-date=12 December 2020 | archive-url=https://web.archive.org/web/20201212165133/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/kixelle | url-status=live }} The applicant for this medicinal product is Mylan IRE Healthcare Limited. Kixelle was approved for medical use in the European Union in February 2021.{{cite web | title=Kixelle EPAR | website=European Medicines Agency (EMA) | date=9 December 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/kixelle | access-date=16 March 2021 | archive-date=29 June 2021 | archive-url=https://web.archive.org/web/20210629235515/https://www.ema.europa.eu/en/medicines/human/EPAR/kixelle | url-status=live }} Kixelle was renamed to Kirsty.{{cite web | title=Kirsty EPAR | website=European Medicines Agency (EMA) | date=9 December 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/kirsty-previously-kixelle | access-date=14 September 2021 | archive-date=15 September 2021 | archive-url=https://web.archive.org/web/20210915064025/https://www.ema.europa.eu/en/medicines/human/EPAR/kirsty-previously-kixelle | url-status=live }}

Trurapi was approved for medical use in Canada in October 2020.{{cite web | title=Summary Basis of Decision (SBD) for Trurapi | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00515&lang=en | access-date=29 May 2022 | archive-date=30 May 2022 | archive-url=https://web.archive.org/web/20220530050752/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00515&lang=en | url-status=live }}

Truvelog and Truvelog Solostar were approved for medical use in Australia in October 2020.{{cite web | title=Truvelog | website=Therapeutic Goods Administration (TGA) | date=23 October 2020 | url=https://www.tga.gov.au/apm-summary/truvelog | access-date=12 June 2021 | archive-date=13 June 2021 | archive-url=https://web.archive.org/web/20210613062838/https://www.tga.gov.au/apm-summary/truvelog | url-status=live }}{{cite web | title=Truvelog Solostar ARTG | website=Therapeutic Goods Administration (TGA) | url=https://tga-search.clients.funnelback.com/s/search.html?collection=tga-artg&profile=record&meta_i=325474 | access-date=12 June 2021 | archive-date=13 June 2021 | archive-url=https://web.archive.org/web/20210613062838/https://tga-search.clients.funnelback.com/s/search.html?collection=tga-artg&profile=record&meta_i=325474 | url-status=live }}

In October 2021, Kirsty was approved for medical use in Canada.{{cite web | title=Summary Basis of Decision (SBD) for Kirsty | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00570&lang=en | access-date=29 May 2022 | archive-date=29 May 2022 | archive-url=https://web.archive.org/web/20220529194843/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00570&lang=en | url-status=live }}

In February 2022, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Truvelog Mix 30, intended for the treatment of diabetes. The applicant for this medicinal product is sanofi-aventis groupe.{{cite web | title=Truvelog Mix 30: Pending EC decision | website=European Medicines Agency | date=24 February 2022 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/truvelog-mix-30 | access-date=27 February 2022 | archive-date=27 February 2022 | archive-url=https://web.archive.org/web/20220227042953/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/truvelog-mix-30 | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. It was approved for medical use in the European Union in April 2022.{{cite web | title=Truvelog Mix 30 EPAR | website=European Medicines Agency | date=23 February 2022 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/truvelog-mix-30 | access-date=16 June 2022 | archive-date=17 June 2022 | archive-url=https://web.archive.org/web/20220617060422/https://www.ema.europa.eu/en/medicines/human/EPAR/truvelog-mix-30 | url-status=live }}{{cite web | title=Truvelog Mix 30 Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1639.htm | access-date=3 March 2023}}

In February 2025, insulin aspart-szjj, sold under the brand names Merilog and Merilog Solostar, is a biosimilar to Novolog that was approved for medical use in the United States in February 2025. It is the first biosimilar to Novolog approved by the US Food and Drug Administration (FDA).{{cite press release | title=FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes | website=U.S. Food and Drug Administration (FDA) | date=14 February 2025 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-rapid-acting-insulin-biosimilar-product-treatment-diabetes | access-date=16 February 2025}} {{PD-notice}} The FDA granted approval of Merilog to Sanofi-Aventis. Merilog is the third insulin biosimilar product approved by the FDA and it joins the two long-acting insulin biosimilar products approved by the FDA in 2021.

{{As of|2018}}, there is a lack of compelling evidence to conclude superiority of insulin aspart over human insulin in type 2 diabetes.{{cite journal | vauthors = Fullerton B, Siebenhofer A, Jeitler K, Horvath K, Semlitsch T, Berghold A, Gerlach FM | title = Short-acting insulin analogues versus regular human insulin for adult, non-pregnant persons with type 2 diabetes mellitus | journal = The Cochrane Database of Systematic Reviews | volume = 12 | issue = 12 | pages = CD013228 | date = December 2018 | pmid = 30556900 | pmc = 6517032 | doi = 10.1002/14651858.CD013228 }} It is thus unclear why the shifting of people from human insulin to insulin aspart has occurred.{{cite journal | vauthors = Cohen D, Carter P | title = How small changes led to big profits for insulin manufacturers | journal = BMJ | volume = 341 | pages = c7139 | date = December 2010 | pmid = 21159773 | doi = 10.1136/bmj.c7139 | s2cid = 30709912 }} In type 1 diabetes it appears to result in slightly better blood sugar control.{{cite journal | vauthors = Fullerton B, Siebenhofer A, Jeitler K, Horvath K, Semlitsch T, Berghold A, Plank J, Pieber TR, Gerlach FM | title = Short-acting insulin analogues versus regular human insulin for adults with type 1 diabetes mellitus | journal = The Cochrane Database of Systematic Reviews | volume = 2016 | issue = 6 | pages = CD012161 | date = June 2016 | pmid = 27362975 | pmc = 6597145 | doi = 10.1002/14651858.CD012161 }}

Insulin aspart was approved for medical use in the United States in 2000.

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