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
-

Substitution of First Phase Insulin Response in Patient With Type 2 Diabetes.

Phase 4
Conditions
Type 2 Diabetes
First Posted Date
2005-11-15
Last Posted Date
2005-11-15
Lead Sponsor
University Hospital, Gentofte, Copenhagen
Target Recruit Count
20
Registration Number
NCT00254085
Locations
🇩🇰

Gentofte University Hospital, Hellerup, Denmark

Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 1
First Posted Date
2005-09-16
Last Posted Date
2017-01-27
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
501
Registration Number
NCT00184665
Locations
🇹🇷

Novo Nordisk Investigational Site, Istanbul, Turkey

Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2005-09-16
Last Posted Date
2017-03-09
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
708
Registration Number
NCT00184600
Locations
🇬🇧

Novo Nordisk Investigational Site, Wirral, Merseyside, United Kingdom

Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes

Phase 1
Completed
Conditions
Diabetes
Delivery Systems
Diabetes Mellitus, Type 2
First Posted Date
2005-09-16
Last Posted Date
2016-10-17
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
22
Registration Number
NCT00184613
Locations
🇩🇰

Novo Nordisk Investigational Site, Århus C, Denmark

South Danish Diabetes Study: Evaluation of the Antidiabetic Treatment of Type 2 Diabetes Mellitus

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
First Posted Date
2005-07-21
Last Posted Date
2008-06-19
Lead Sponsor
Odense University Hospital
Target Recruit Count
400
Registration Number
NCT00121966
Locations
🇩🇰

Diabetes Research Center, Odense, Denmark

Comparison of Insulin Detemir Given Once or Twice Daily in Type 1 Diabetes

Phase 4
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 1
First Posted Date
2005-07-08
Last Posted Date
2017-06-02
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
520
Registration Number
NCT00117780
Locations
🇱🇺

Novo Nordisk Investigational Site, Luxembourg, Luxembourg

A Study of the Treatment of Type 2 Diabetes With an Insulin Infusion Pump

Phase 1
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Delivery Systems
First Posted Date
2005-06-27
Last Posted Date
2016-10-18
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
71
Registration Number
NCT00115973
Locations
🇺🇸

Novo Nordisk Investigational Site, San Antonio, Texas, United States

Comparison of Insulin Detemir With Insulin Glargine in Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes
First Posted Date
2005-03-23
Last Posted Date
2017-01-31
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
389
Registration Number
NCT00106366
Locations
🇵🇷

Novo Nordisk Investigational Site, Rio Piedras, Puerto Rico

Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 1
First Posted Date
2004-11-18
Last Posted Date
2016-12-22
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
299
Registration Number
NCT00097071
Locations
🇺🇸

Novo Nordisk Investigational Site, Milwaukee, Wisconsin, United States

Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
First Posted Date
2004-11-18
Last Posted Date
2017-01-27
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
324
Registration Number
NCT00097084
Locations
🇸🇪

Novo Nordisk Investigational Site, Ängelholm, Sweden

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