MedPath

Insulin human

Generic Name
Insulin human
Brand Names
Actraphane, Actrapid, Afrezza, Entuzity, Exubera, Humulin, Humulin N, Humulin R, Insulatard, Insuman, Myxredlin, Novolin, Novolin N, Novolin R, Protaphane, Mixtard
Drug Type
Biotech
CAS Number
11061-68-0
Unique Ingredient Identifier
1Y17CTI5SR
Background

Human Insulin, also known as Regular Insulin, is a short-acting form of insulin used for the treatment of hyperglycemia caused by Type 1 and Type 2 Diabetes. Human insulin is produced by recombinant DNA technology and is identical to endogenously produced insulin. Typically prescribed for the management of diabetes mellitus, insulin is 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 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 Humulin R or Novolin R, human insulin begins to exert its effects within 30 minutes of subcutaneous administration, while peak levels occur 3-4 hours after administration. Due to its quick onset of action, human insulin 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.

Human insulin is also available in an inhalable form, intended to be used as a bolus meal-time insulin. Exubera was the first inhaled insulin available on the market and was developed by Inhale Therapeutics (later named Nektar Therapeutics). Unfortunately, limited uptake by physicians and patients, poor sales, bulky packaging, and concerns over the possible impact on lung cancer development resulted in Exubera products being withdrawn from the US markets . Exubera was followed by Afrezza, a monomeric inhaled insulin developed by Mannkind Corporation, which received FDA approval in 2016. While still available in the US, Afrezza has had similar concerns associated with its use, and had an FDA "black box" warning added to it to warn about use in patients with chronic lung disease. Afrezza does not currently have Health Canada or European Medicines Agency approval for marketing in Canada or the EU.

Human Insulin is a 51 residue peptide hormone produced by recombinant DNA technology by inserting the human insulin gene into Escherichia coli bacteria or Saccharomyces cerevisiae. The structure is identical to native human insulin, with two amino acid chains covalently linked by disulfide bonds.

Human insulin is also available in an intermediate-acting form as NPH (Neutral Protamine Hagedorn) as the marketed products Novolin N and Humulin N. NPH insulin is provided as a crystalline suspension of insulin with protamine and zinc, resulting in an onset of action in 1 to 3 hours, duration of action up to 24 hours, and peak action from 6 to 8 hours. Due to the added crystals, NPH insulin is typically cloudy when compared to other forms of insulin and has a neutral pH.

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

Human insulin is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

Associated Conditions
Diabetes Mellitus, Type 1 Diabetes Mellitus

Management of Type 2 Diabetes After Gastric Bypass Surgery

Not Applicable
Terminated
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-10-04
Last Posted Date
2020-08-21
Lead Sponsor
Imperial College London
Target Recruit Count
50
Registration Number
NCT01213563
Locations
🇬🇧

Imperial College London, Charing Cross Hospital, London, United Kingdom

Investigating the Accuracy of the Home Glucose Monitors in Hypoglycemia

Phase 4
Completed
Conditions
Hypoglycemia
Interventions
First Posted Date
2009-11-13
Last Posted Date
2009-11-13
Lead Sponsor
Gulhane School of Medicine
Target Recruit Count
51
Registration Number
NCT01013402
Locations
🇹🇷

Gulhane School of Medicine Department of Endocrinology and Metabolism, Ankara, Turkey

Treat-to-target Trial of Basal Insulin in Post-transplant Hyperglycemia

Phase 2
Completed
Conditions
Hyperglycemia
Interventions
First Posted Date
2009-01-27
Last Posted Date
2012-09-03
Lead Sponsor
Marcus Saemann
Target Recruit Count
50
Registration Number
NCT00830297
Locations
🇦🇹

Medical University of Vienna, Department of Internal Medicine III, Vienna, Austria

Observational Study to Investigate the Efficacy and Safety of Human Insulin or Insulin Analogue Treatments in Type 2 Diabetes Subjects

Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
Drug: insulin analogue
First Posted Date
2008-12-11
Last Posted Date
2016-10-28
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
4847
Registration Number
NCT00806936
Locations
🇨🇳

Novo Nordisk Investigational Site, Beijing, Beijing, China

Detemir Energy Expenditure Study

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Obesity
Interventions
First Posted Date
2008-11-11
Last Posted Date
2023-05-31
Lead Sponsor
University of Surrey
Target Recruit Count
30
Registration Number
NCT00788840
Locations
🇬🇧

Cedar Centre, Royal Surrey County Hospital, Guildford, Surrey, United Kingdom

Follow-Up Study for Exubera

Completed
Conditions
Diabetes Mellitus
Interventions
Other: Randomized diabetes therapy
First Posted Date
2008-08-14
Last Posted Date
2012-10-23
Lead Sponsor
Pfizer
Target Recruit Count
7439
Registration Number
NCT00734591
Locations
🇬🇧

Pfizer Investigational Site, Westbury, United Kingdom

Insulin and Sarcopenia in the Elderly

Phase 1
Completed
Conditions
Sarcopenia
Interventions
First Posted Date
2008-06-04
Last Posted Date
2016-12-12
Lead Sponsor
The University of Texas Medical Branch, Galveston
Target Recruit Count
88
Registration Number
NCT00690534
Locations
🇺🇸

Sealy Center on Aging, University of Texas Medical Branch, Galveston, Texas, United States

Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Insulin in Elderly People With Type 2 Diabetes

Phase 4
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
First Posted Date
2008-05-13
Last Posted Date
2017-03-16
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
19
Registration Number
NCT00676819
Locations
🇩🇪

Novo Nordisk Investigational Site, Köln, Germany

The Metabolic Effects of Acute Hyperglycemia in Patients With Type 2 Diabetes

Not Applicable
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2008-04-07
Last Posted Date
2012-09-18
Lead Sponsor
University of Aarhus
Target Recruit Count
18
Registration Number
NCT00653510
Locations
🇩🇰

Department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus, Denmark

Severe Insulin Resistance in Patients With Type 2 Diabetes

Not Applicable
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2008-04-07
Last Posted Date
2013-03-11
Lead Sponsor
University of Aarhus
Target Recruit Count
8
Registration Number
NCT00654056
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