MedPath

Insulin aspart

Generic Name
Insulin aspart
Brand Names
Fiasp, Novolog, Novolog Mix, Novomix, Novorapid, Novorapid Penfill, Ryzodeg, Truvelog Mix 30, Kirsty (previously Kixelle), NovoRapid, Insulin aspart Sanofi, NovoMix
Drug Type
Biotech
Chemical Formula
-
CAS Number
116094-23-6
Unique Ingredient Identifier
D933668QVX
Background

Insulin aspart is a rapid-acting form of insulin used for the treatment of hyperglycemia caused by Type 1 and Type 2 Diabetes. Insulin is typically prescribed for the management of diabetes mellitus to mimic the activity of endogenously produced human insulin, a peptide hormone produced by beta cells of the pancreas that promotes glucose metabolism. Insulin is released from the pancreas following a meal to promote the uptake of glucose from the blood into internal organs and tissues such as the liver, fat cells, and skeletal muscle. Absorption of glucose into cells allows for its transformation into glycogen or fat for storage. Insulin also inhibits hepatic glucose production, enhances protein synthesis, and inhibits lipolysis and proteolysis among many other functions.

Insulin is an important treatment in the management of Type 1 Diabetes (T1D) which is caused by an autoimmune reaction that destroys the beta cells of the pancreas, resulting in the body not being able to produce or synthesize the insulin needed to manage circulating blood sugar levels. As a result, people with T1D rely primarily on exogenous forms of insulin, such as insulin aspart, to lower glucose levels in the blood. Insulin is also used in the treatment of Type 2 Diabetes (T2D), another form of diabetes mellitus that is a slowly progressing metabolic disorder caused by a combination of genetic and lifestyle factors that promote chronically elevated blood sugar levels. Without treatment or improvement in non-pharmacological measures such as diet and exercise to lower blood glucose, high blood sugar eventually causes cellular resistance to endogenous insulin, and in the long term, damage to pancreatic islet cells. Insulin is typically prescribed later in the course of T2D, after trying several oral medications such as Metformin, Gliclazide, or Sitagliptin have been tried, when sufficient damage has been caused to pancreatic cells that the body is no longer able to produce insulin on its own.

Marketed as the brand name product NovoRapid, insulin aspart begins to exert its effects within 15 minutes of subcutaneous administration, while peak levels occur 30 to 90 minutes after administration. Due to its duration of action of around 5 hours, NovoRapid is considered "bolus insulin" as it provides high levels of insulin in a short period of time to mimic the release of endogenous insulin from the pancreas after meals. Bolus insulin is often combined with once daily, long-acting "basal insulin" such as Insulin detemir, Insulin degludec, and Insulin glargine to provide low concentrations of background insulin that can keep blood sugar stable between meals or overnight. Use of basal and bolus insulin together is intended to mimic the pancreas' production of endogenous insulin, with a goal of avoiding any periods of hypoglycemia.

Insulin aspart is a recombinant, biosynthetic, fast-acting insulin analogue. Compared to human insulin, it has a single amino acid substitution at position B28 where proline is replaced with aspartic acid. This substitution decreases its propensity to form hexamers and gives it a higher rate of absorption following subcutaneous administration compared to native insulin. Insulin aspart is produced in a genetically modified strain of Saccharomyces cerevisiae (baker's yeast)

Without an adequate supply of insulin to promote absorption of glucose from the bloodstream, blood sugar levels can climb to dangerously high levels and can result in symptoms such as fatigue, headache, blurred vision, and increased thirst. If left untreated, the body starts to break down fat, instead of glucose, for energy which results in a build-up of ketone acids in the blood and a syndrome called ketoacidosis, which is a life-threatening medical emergency. In the long term, elevated blood sugar levels increase the risk of heart attack, stroke, and diabetic neuropathy.

Indication

Insulin aspart is indicated to improve glycemic control in adults and children with diabetes mellitus.

Associated Conditions
Diabetes Mellitus, Diabetic Ketoacidosis, Gestational Diabetes Mellitus (GDM), Hyperglycemia during critical illness
Associated Therapies
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The Study of Quadruple Therapy Intranasal Insulin, Zinc, Gabapentin, Ice Cube Stimulation for Post COVID-19 Smell and Taste Dysfunctions

Phase 1
Conditions
Taste Disorder, Secondary, Bitter
Taste Disorders
Taste Disorder, Secondary, Sweet
Smell Disorder
Smell Dysfunction
Interventions
First Posted Date
2021-11-03
Last Posted Date
2021-11-03
Lead Sponsor
Ministry of Health, Saudi Arabia
Target Recruit Count
22
Registration Number
NCT05104424

A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3)

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2021-08-19
Last Posted Date
2024-11-14
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
679
Registration Number
NCT05013229
Locations
🇺🇸

Endeavor Health, Skokie, Illinois, United States

🇺🇸

Andres Garcia-Zuniga, MD, P.A, Laredo, Texas, United States

🇫🇷

Centre de Recherche Clinique Portes Du Sud, Venissieux, France

and more 126 locations

A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Glargine, Both in Combination With Mealtime Insulin, in People With Type 2 Diabetes Who Use Daily Insulin and Mealtime Insulin (ONWARDS 4)

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2021-05-11
Last Posted Date
2024-05-29
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
582
Registration Number
NCT04880850
Locations
🇺🇸

UT Southwestern Med Cntr, Dallas, Texas, United States

🇯🇵

Noritake Clinic, Ushiku-shi, Ibaraki, Japan

🇺🇸

Amarillo Med Spec LLP, Amarillo, Texas, United States

and more 78 locations

A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6)

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 1
Interventions
First Posted Date
2021-04-19
Last Posted Date
2023-09-14
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
582
Registration Number
NCT04848480
Locations
🇯🇵

Yuri Ono Clinic, Sapporo-shi, Hokkaido, Japan

🇬🇧

Churchill Hospital, Oxford, United Kingdom

🇬🇧

Lister Hospital, Stevenage, United Kingdom

and more 94 locations

Fast-Acting Insulin Aspart and Insulin Pump Settings

Phase 4
Conditions
Type 1 Diabetes
Interventions
First Posted Date
2020-11-09
Last Posted Date
2021-02-16
Lead Sponsor
Kirsten Nørgaard
Target Recruit Count
40
Registration Number
NCT04620967
Locations
🇩🇰

Steno Diabetes Center Copenhagen, Gentofte, Denmark

Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Interventions
First Posted Date
2020-10-19
Last Posted Date
2024-03-20
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
331
Registration Number
NCT04588259
Locations
🇨🇳

Chongqing University Three Gorges Hospital, ChongQing, Chongqing, China

🇨🇳

Suzhou Municipal Hospital, Suzhou, Jiangsu, China

🇨🇳

Nanjing Jiangning Hospital, Nanjing, Jiangsu, China

and more 33 locations

Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With T2D

Phase 4
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2020-09-04
Last Posted Date
2024-07-29
Lead Sponsor
The Cleveland Clinic
Target Recruit Count
60
Registration Number
NCT04538352
Locations
🇺🇸

Cleveland Clinic, Cleveland, Ohio, United States

Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus

Phase 3
Completed
Conditions
Type 2 Diabetes Treated With Insulin
Interventions
First Posted Date
2020-07-07
Last Posted Date
2024-03-19
Lead Sponsor
Boston Medical Center
Target Recruit Count
137
Registration Number
NCT04460326
Locations
🇺🇸

Boston Medical Center, Boston, Massachusetts, United States

Basal Insulin Glycemic ControL With DEglugec vs Aspart Via Pump

Phase 4
Completed
Conditions
Type1 Diabetes Mellitus
Interventions
First Posted Date
2020-06-01
Last Posted Date
2021-02-24
Lead Sponsor
Mountain Diabetes and Endocrine Center
Target Recruit Count
59
Registration Number
NCT04409587
Locations
🇺🇸

Mountain Diabetes and Endocrine Center, Asheville, North Carolina, United States

A Study to Compare Pharmacokinetics and Pharmacodynamics of Insulin Aspart to NovoRapid® Penfill® in Healthy Subjects

Not Applicable
Completed
Conditions
Clamp Study
Interventions
First Posted Date
2019-12-03
Last Posted Date
2019-12-03
Lead Sponsor
Geropharm
Target Recruit Count
26
Registration Number
NCT04184466
Locations
🇷🇺

Endocrinology Research Centre, Moscow, Russian Federation

🇷🇺

Almazov National Medical Research Centre, Saint Petersburg,, Russian Federation

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