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
-

The Copenhagen Insulin and Metformin Therapy Trial

First Posted Date
2008-04-14
Last Posted Date
2014-02-04
Lead Sponsor
Steno Diabetes Center Copenhagen
Target Recruit Count
415
Registration Number
NCT00657943
Locations
🇩🇰

Rigshospitalet, Copenhagen, Denmark

🇩🇰

Bispebjerg Hospital, Copenhagen, Denmark

🇩🇰

Frederiksberg Hospital, Frederiksberg, Denmark

and more 6 locations

A Study to Evaluate the Effect of Nasal Insulin on Postprandial Glycemic Control in Type 2 Diabetic Patients

First Posted Date
2008-02-27
Last Posted Date
2008-05-20
Lead Sponsor
Nastech Pharmaceutical Company, Inc.
Target Recruit Count
18
Registration Number
NCT00624767
Locations
🇺🇸

Diabetes and Glandular Disease Research Associates, San Antonio, Texas, United States

Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689

First Posted Date
2008-02-25
Last Posted Date
2016-11-28
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
146
Registration Number
NCT00623194
Locations
🇬🇧

Novo Nordisk Investigational Site, Norfolk, United Kingdom

Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes

First Posted Date
2008-02-11
Last Posted Date
2017-03-03
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
178
Registration Number
NCT00612040
Locations
🇸🇪

Novo Nordisk Investigational Site, Umeå, Sweden

Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus

First Posted Date
2008-02-05
Last Posted Date
2010-08-31
Lead Sponsor
Sanofi
Target Recruit Count
289
Registration Number
NCT00607087
Locations
🇬🇧

Sanofi-Aventis Administrative Office, Guildford Surrey, United Kingdom

Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2008-01-30
Last Posted Date
2017-06-27
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
719
Registration Number
NCT00605020
Locations
🇨🇭

Novo Nordisk Investigational Site, Zürich, Switzerland

Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2008-01-30
Last Posted Date
2017-03-01
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
241
Registration Number
NCT00604656
Locations
🇵🇱

Novo Nordisk Investigational Site, Wroclaw, Poland

Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2008-01-25
Last Posted Date
2017-01-06
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
394
Registration Number
NCT00600626
Locations
🇬🇧

Novo Nordisk Investigational Site, York, United Kingdom

Human Insulin NPH and Insulin Aspart in Type 1 Diabetes

Phase 4
Completed
Conditions
First Posted Date
2008-01-18
Last Posted Date
2016-12-22
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
91
Registration Number
NCT00597233
Locations
🇦🇷

Novo Nordisk Investigational Site, Junin, Argentina

Efficacy and Safety of Insulin Detemir in Type 1 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2008-01-16
Last Posted Date
2017-02-24
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
114
Registration Number
NCT00595374
Locations
🇳🇱

Novo Nordisk Investigational Site, Zwolle, Netherlands

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