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
-

Special Survey of Production of Insulin Aspart Specific Antibody

First Posted Date
2011-12-07
Last Posted Date
2016-03-04
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
204
Registration Number
NCT01487369

Safety and Efficacy Study of Insulin Lispro Versus Insulin Aspart in Participants With Type 2 Diabetes on Insulin Pump Therapy

First Posted Date
2011-11-18
Last Posted Date
2014-03-20
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
122
Registration Number
NCT01474538
Locations
🇺🇸

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Salt Lake City, Utah, United States

A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes

First Posted Date
2011-11-10
Last Posted Date
2015-02-23
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
40
Registration Number
NCT01469143

Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes

First Posted Date
2011-11-08
Last Posted Date
2017-02-23
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
26
Registration Number
NCT01467141
Locations
🇩🇪

Novo Nordisk Investigational Site, Osnabrück, Germany

Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-11-03
Last Posted Date
2016-10-28
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
24
Registration Number
NCT01464099
Locations
🇺🇸

Novo Nordisk Investigational Site, Chula Vista, California, United States

Human Insulin Analogs: Evaluation of Inflammatory mRNA Expression of Macrophages and Endothelial Function of Short-acting Insulin - HERMES Pilot Study

First Posted Date
2011-08-16
Last Posted Date
2012-03-05
Lead Sponsor
ikfe-CRO GmbH
Target Recruit Count
12
Registration Number
NCT01417897
Locations
🇩🇪

ife GmbH, Clinic, Mainz, Rhineland-Palatinate, Germany

Investigation of the Impact of Different Application Volumes of Insulin Aspart in Subjects With Type 1 Diabetes

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-07-21
Last Posted Date
2012-04-20
Lead Sponsor
Medical University of Graz
Target Recruit Count
12
Registration Number
NCT01399346
Locations
🇦🇹

Medical University of Graz, Graz, Austria

Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin

First Posted Date
2011-07-06
Last Posted Date
2017-03-06
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
413
Registration Number
NCT01388361
Locations
🇪🇸

Novo Nordisk Investigational Site, Sevilla, Spain

Carbohydrate Consumption as a Factor in Aspart Dosing

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2011-04-12
Last Posted Date
2023-05-01
Lead Sponsor
Rush University Medical Center
Target Recruit Count
14
Registration Number
NCT01333514
Locations
🇺🇸

Rush University Medical Center, Chicago, Illinois, United States

A Trial Investigating the Pharmacokinetic Properties of NN1218 in Subjects With Diabetes Mellitus, Type 1

First Posted Date
2011-02-15
Last Posted Date
2015-02-23
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
40
Registration Number
NCT01296438
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