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

Evaluating the Efficacy of Topical Insulin for the Restoration of Ocular Surface Interface in Dry Eye Disease.

Phase 4
Recruiting
Conditions
Dry Eye
Insulin Sensitivity
Interventions
Drug: Artificial tear
First Posted Date
2025-04-23
Last Posted Date
2025-04-23
Lead Sponsor
Khyber Teaching Hospital
Target Recruit Count
126
Registration Number
NCT06939959
Locations
🇵🇰

Khyber Teaching Hospital, Peshawar, Khyber Pukhtunkhwa, Pakistan

Human Models of Selective Insulin Resistance: Pancreatic Clamp

Phase 1
Not yet recruiting
Conditions
Insulin Resistance
Hyperinsulinemia
Metabolic Dysfunction Associated Steatotic Liver Disease
Non-Alcoholic Fatty Liver Disease
Prediabetic State
Obesity
Interventions
Drug: Growth Hormone, Human
Diagnostic Test: [6,6-2H2] D-glucose
Diagnostic Test: [1-13C1] sodium acetate
Dietary Supplement: Nestle BOOST Plus
Dietary Supplement: KIND Bar
Device: Harvard Apparatus PHD ULTRA CP syringe pump
Device: Yellow Springs Instruments (YSI) 2500 Biochemistry Glucose/Lactate Analyzer
First Posted Date
2024-08-16
Last Posted Date
2025-01-08
Lead Sponsor
Columbia University
Target Recruit Count
36
Registration Number
NCT06558422
Locations
🇺🇸

Columbia University Irving Medical Center, New York, New York, United States

Insulin Degludec vs Insulin Glargine for Glycemic Control in Critical Illness Hyperglycemia

Not Applicable
Completed
Conditions
Critical Illness
Glycemic Control
Insulin
Interventions
First Posted Date
2023-12-21
Last Posted Date
2024-08-05
Lead Sponsor
Ain Shams University
Target Recruit Count
90
Registration Number
NCT06178874
Locations
🇪🇬

Ain shams university, Cairo, Egypt

Dexamethasone/Pancreatic Clamp P&F

Phase 1
Withdrawn
Conditions
Insulin Resistance
Non-Alcoholic Fatty Liver Disease
Prediabetic State
Overweight and Obesity
Interventions
Other: [6,6-2H2] D-glucose
Dietary Supplement: BOOST Plus
Device: Harvard Apparatus PHD ULTRA CP syringe pump
Device: Yellow Springs Instruments (YSI) 2500 Biochemistry Glucose/Lactate Analyzer
Other: Normal saline
Other: Human albumin
First Posted Date
2023-11-13
Last Posted Date
2024-07-10
Lead Sponsor
Columbia University
Registration Number
NCT06126354
Locations
🇺🇸

Columbia University Irving Medical Center, New York, New York, United States

Comparative Study of Rinsulin R (GEROPHARM) and Humulin Regular (Eli Lilly) Euglycemic Hyperinsulinemic Clamp Method

Not Applicable
Completed
Conditions
Therapeutic Equivalency
Bioequivalence
Interventions
First Posted Date
2023-09-22
Last Posted Date
2023-09-22
Lead Sponsor
Geropharm
Target Recruit Count
20
Registration Number
NCT06050343
Locations
🇷🇺

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

5 Versus 10 Units of Insulin in Hyperkalemia Management

Phase 4
Recruiting
Conditions
Hyperkalemia
Electrolyte Imbalance
Potassium Imbalance
Electrolyte Disturbance
Interventions
First Posted Date
2023-09-14
Last Posted Date
2023-10-03
Lead Sponsor
Oman Medical Speciality Board
Target Recruit Count
336
Registration Number
NCT06036823
Locations
🇴🇲

Sultan Qaboos University hospital, Seeb, Muscat, Oman

Comparative Efficacy of a Two Daily Mixed Insulin Injection Versus a Basal-bolus Scheme With Human Insulin

Phase 4
Completed
Conditions
Type 1 Diabetes
Interventions
Drug: premix insulin human isophane suspension and insulin human
First Posted Date
2023-03-14
Last Posted Date
2024-12-12
Lead Sponsor
Université NAZI BONI
Target Recruit Count
22
Registration Number
NCT05768191
Locations
🇧🇫

CHU Souro Sanou, Bobo-Dioulasso, Houet, Burkina Faso

🇧🇫

CHU de Tengandogo, Ouagadougou, Kadiogo, Burkina Faso

🇧🇫

CHU Yalgado Ouedraogo, Ouagadougou, Kadiogo, Burkina Faso

AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study

Phase 1
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2023-03-03
Last Posted Date
2024-02-16
Lead Sponsor
Arecor Limited
Target Recruit Count
41
Registration Number
NCT05754424
Locations
🇦🇹

Clinical Trials Unit, Medical University of Graz, Graz, Austria

Pancreatic Clamp in NAFLD

Phase 1
Suspended
Conditions
Obesity
Prediabetic State
Insulin Resistance
Hyperinsulinemia
Non-Alcoholic Fatty Liver Disease
Interventions
Drug: Growth Hormone, Human
Other: [6,6-2H2] D-glucose
Dietary Supplement: BOOST Plus
Dietary Supplement: CORE Bar
Device: Harvard Apparatus PHD ULTRA CP syringe pump
Device: Yellow Springs Instruments (YSI) 2500 Biochemistry Glucose/Lactate Analyzer
First Posted Date
2023-02-13
Last Posted Date
2025-04-03
Lead Sponsor
Columbia University
Target Recruit Count
42
Registration Number
NCT05724134
Locations
🇺🇸

Columbia University Irving Medical Center, New York, New York, United States

Afrezza With Basal Combination (ABC): Afrezza® Combined With AID Pump or Insulin Degludec in Adults With Type 1 Diabetes

Phase 4
Completed
Conditions
Type 1 Diabetes
Interventions
Device: Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID)
First Posted Date
2022-02-17
Last Posted Date
2025-04-08
Lead Sponsor
Mannkind Corporation
Target Recruit Count
33
Registration Number
NCT05243628
Locations
🇺🇸

Diabetes Treatment Center, Loma Linda University, Loma Linda, California, United States

🇺🇸

Texas Diabetes and Endocrinology, Austin, Texas, United States

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