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

Dose Response Study of Transdermal Human Insulin in Patients

Phase 2
Not yet recruiting
Conditions
Glucose, High Blood
Interventions
Device: Finger-actuated, Metered Pump Sprayer
First Posted Date
2021-12-16
Last Posted Date
2024-11-21
Lead Sponsor
Transdermal Delivery Solutions Corp
Target Recruit Count
30
Registration Number
NCT05159453
Locations
🇺🇸

Langford Research Institute, Palm Beach Gardens, Florida, United States

Impact of Intranasal Insulin on Sympathetic Activity and Cerebral Vasodilation

Early Phase 1
Active, not recruiting
Conditions
Healthy
Vasodilation
Insulin Resistance
Autonomic Dysfunction
Obesity
Interventions
Other: Carbon dioxide breathing
Other: Neurovascular Coupling
First Posted Date
2021-12-10
Last Posted Date
2025-03-28
Lead Sponsor
University of Missouri-Columbia
Target Recruit Count
65
Registration Number
NCT05153395
Locations
🇺🇸

University of Missouri, Columbia, Missouri, United States

Metabolic Adaptation to High-frequent Hypoglycaemia in Type 1 Diabetes

Not Applicable
Active, not recruiting
Conditions
Type1diabetes
Interventions
Procedure: Muscle biopsy
Procedure: Adipose tissue biopsy
Device: IPRO 2 Medtronic Minimed
Procedure: 7 Tesla (7T) Magnetic Resonance Imaging
Procedure: Indirect Calorimetry using Jaeger Oxycon Champion
Procedure: Core temperature and thermography using Thermovision SC645
Device: Freestyle Libre 2
First Posted Date
2021-10-27
Last Posted Date
2023-05-03
Lead Sponsor
Nordsjaellands Hospital
Target Recruit Count
60
Registration Number
NCT05095259
Locations
🇩🇰

Nordsjaellands Hospital, Hillerød, Denmark

🇩🇰

Steno Diabetes Center Copenhagen, Gentofte, Denmark

A Study Evaluating the Bioavailability of Oral Insulin (N11005)

Phase 1
Completed
Conditions
PK, PD, and Safety
Interventions
First Posted Date
2021-07-23
Last Posted Date
2021-07-28
Lead Sponsor
Beijing Hospital
Target Recruit Count
12
Registration Number
NCT04975022
Locations
🇨🇳

Beijing Hospital, Beijing, China

Afrezza® INHALE-1 Study in Pediatrics

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Interventions
Biological: Rapid-acting Insulin Analog
First Posted Date
2021-07-23
Last Posted Date
2025-05-06
Lead Sponsor
Mannkind Corporation
Target Recruit Count
319
Registration Number
NCT04974528
Locations
🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

🇺🇸

Rocky Mountain Clinical Research, Idaho Falls, Idaho, United States

🇺🇸

Joe DiMaggio Children's Hospital, Hollywood, Florida, United States

and more 36 locations

Insulin for Hyperglycemia in Stroke Trial

Phase 4
Completed
Conditions
Stroke, Acute
Hyperglycemia
Interventions
Drug: Analog Insulin
First Posted Date
2021-04-08
Last Posted Date
2021-12-06
Lead Sponsor
National Institute of Neurosciences and Hospital, Dhaka
Target Recruit Count
452
Registration Number
NCT04834362
Locations
🇧🇩

National Institute of Neurosciences and Hospital, Dhaka, Bangladesh

Intraoperative Insulin Administration at Cardiac Surgery for Diabetic Patients

Phase 4
Completed
Conditions
Cardiac Event
Diabetes Mellitus
Interventions
First Posted Date
2021-04-01
Last Posted Date
2021-04-01
Lead Sponsor
The Hashemite University
Target Recruit Count
70
Registration Number
NCT04824586
Locations
🇯🇴

Prince Hamza Hospital, Amman, Jordan

Comparative Study of Rinsulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (Lilly France, France) Using the Euglycemic Hyperinsulinemic Clamp Method

Not Applicable
Completed
Conditions
Bioequivalence
Pharmacokinetics
Interventions
First Posted Date
2020-08-06
Last Posted Date
2020-08-06
Lead Sponsor
Geropharm
Target Recruit Count
52
Registration Number
NCT04501250
Locations
🇷🇺

Yarosslavl Clinical Hospital #3, Yaroslavl, Russian Federation

Comparative Study of the Pharmacokinetics of Rinsulin® Mix 30/70, Suspension for Subcutaneous Administration, 100 IU / ml (OJSC GEROPHARM-Bio, Russia) and Humulin® M3, Suspension for Subcutaneous Administration, 100 IU / ml (Lilly France, France) Using the Euglycemic Hyperinsulinemic Clamp Method

Not Applicable
Completed
Conditions
Bioequivalence
Interventions
Drug: Rinsulin® mix 30/70
First Posted Date
2020-08-05
Last Posted Date
2020-08-05
Lead Sponsor
Geropharm
Target Recruit Count
32
Registration Number
NCT04498884
Locations
🇷🇺

National Medical Research Center in name of V.A. Almazov " of the Ministry of Health of the Russian Federation, Saint-Petersburg, Russian Federation

🇷🇺

LLC "BioEk", Russian Federation, St. Petersburg, Russian Federation

🇷🇺

"National Medical Research Center of Endocrinology" of the Ministry of Health of the Russian Federation, Moscow, Russian Federation

A Study to Evaluate Time in Range in Type 2 Diabetics Using Afrezza® Plus Basal Insulin Compared to Multiple Daily Injections

Phase 4
Conditions
Type 2 Diabetes Treated With Insulin
Interventions
First Posted Date
2019-10-14
Last Posted Date
2020-01-30
Lead Sponsor
Diabetes and Glandular Disease Clinic
Target Recruit Count
29
Registration Number
NCT04125082
Locations
🇺🇸

Diabetes and Glandular Disease Clinic, P.A., San Antonio, Texas, United States

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