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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
-

Efficacy of Pramlintide on Prevention of Weight Gain Early Onset of Type 1 Diabetes

Phase 4
Withdrawn
Conditions
Type 1 Diabetes
Interventions
Drug: Pramlintide
Drug: Glargine
Drug: Aspart
Drug: Lispro
First Posted Date
2007-07-25
Last Posted Date
2019-01-08
Lead Sponsor
University of Texas Southwestern Medical Center
Registration Number
NCT00505882
Locations
🇺🇸

UT Southwestern at Dallas, Dallas, Texas, United States

Comparison of Insulin Detemir Versus Insulin NPH on Weight Change in Overweight and Obese With Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
First Posted Date
2007-07-20
Last Posted Date
2023-11-02
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
277
Registration Number
NCT00504673

Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia (ALL)

Phase 3
Terminated
Conditions
Leukemia
Lymphoma
Interventions
First Posted Date
2007-07-12
Last Posted Date
2015-06-03
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
52
Registration Number
NCT00500240
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

Self-control Trial to Evaluate the Remission Rate in Newly Diagnosed Type 2 Diabetes Patients After Treatment With Insulin Aspart

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes
First Posted Date
2007-07-02
Last Posted Date
2016-03-04
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
33
Registration Number
NCT00494988

Efficacy and Safety of Insulin Detemir Versus Neutral Protamine Hagedorn (NPH) Insulin in Pregnant Women With Type 1 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 1
Interventions
First Posted Date
2007-05-16
Last Posted Date
2017-03-10
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
470
Registration Number
NCT00474045
Locations
🇬🇧

Novo Nordisk Investigational Site, Watford, United Kingdom

Safety of Inhaled Human Insulin in Subjects With Diabetes Mellitus and Chronic Obstructive Pulmonary Disease (COPD)

Phase 3
Terminated
Conditions
Chronic Obstructive Pulmonary Disease
Diabetes Mellitus, Type 2
Diabetes
Diabetes Mellitus, Type 1
Interventions
Drug: inhaled human insulin
Drug: insulin aspart
First Posted Date
2007-05-14
Last Posted Date
2017-03-01
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
38
Registration Number
NCT00472953
Locations
🇹🇷

Novo Nordisk Investigational Site, Kocaeli, Turkey

Comparison of Insulins Aspart and Lispro in Insulin Pumps

Phase 4
Completed
Conditions
Type 1 Diabetes Mellitus
Interventions
First Posted Date
2007-04-18
Last Posted Date
2021-01-08
Lead Sponsor
Tulane University Health Sciences Center
Target Recruit Count
20
Registration Number
NCT00461331
Locations
🇺🇸

Clinical Translational Unit - Tulane School of Medicine, New Orleans, Louisiana, United States

Changes of the Infusion Rate in Insulin Pump Treatment

Phase 4
Completed
Conditions
Diabetes
Interventions
First Posted Date
2007-03-21
Last Posted Date
2009-07-02
Lead Sponsor
Aarhus University Hospital
Target Recruit Count
10
Registration Number
NCT00449839
Locations
🇩🇰

Aarhus University Hospital, department of Endocrinology and Diabetes, Aarhus C, Aarhus, Denmark

Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Subjects With Type 1 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 1
Interventions
First Posted Date
2007-03-14
Last Posted Date
2024-01-02
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
330
Registration Number
NCT00447382

Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 1
Interventions
First Posted Date
2007-02-14
Last Posted Date
2017-03-10
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
348
Registration Number
NCT00435019
Locations
🇬🇧

Novo Nordisk Investigational Site, Norfolk, United Kingdom

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