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

Brain Insulin Resistance in Mood Disorders

Phase 1
Recruiting
Conditions
Major Depressive Disorder
Bipolar Disorder
Anhedonia
Intranasal Insulin
Interventions
Drug: Diluent
First Posted Date
2019-04-16
Last Posted Date
2023-12-15
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
150
Registration Number
NCT03915613
Locations
🇨🇦

Toronto Western Hospital, Toronto, Ontario, Canada

A Trial to Assess a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus

Phase 1
Completed
Conditions
Type 1 Diabetes Mellitus
Interventions
Drug: ADO09 formulation
Drug: Placebo
First Posted Date
2019-04-16
Last Posted Date
2019-04-16
Lead Sponsor
Adocia
Target Recruit Count
24
Registration Number
NCT03916640
Locations
🇩🇪

Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

Neuro Biomarkers of Smoking Behavior

Phase 2
Terminated
Conditions
Smoking Cessation
Interventions
First Posted Date
2019-01-22
Last Posted Date
2021-03-02
Lead Sponsor
University of Illinois at Chicago
Target Recruit Count
4
Registration Number
NCT03811951
Locations
🇺🇸

University of Illinois Department of Pharmacy Practice, Chicago, Illinois, United States

Pupillography as Screening Tool for Brain Insulin Resistance

Not Applicable
Completed
Conditions
Obesity
Interventions
Drug: placebo
Diagnostic Test: Pupillography
First Posted Date
2018-08-29
Last Posted Date
2019-01-10
Lead Sponsor
University Hospital Tuebingen
Target Recruit Count
22
Registration Number
NCT03651661
Locations
🇩🇪

University of Tuebingen, Department of Internal Medicine IV, Tübingen, Germany

Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients

Phase 3
Completed
Conditions
Type2 Diabetes
Interventions
First Posted Date
2017-10-30
Last Posted Date
2024-06-26
Lead Sponsor
Model Clinical Research LLC
Target Recruit Count
20
Registration Number
NCT03324776
Locations
🇺🇸

MODEL Clinical Research, Baltimore, Maryland, United States

A Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone

Phase 4
Conditions
Diabetes Mellitus, Type 2
Interventions
Other: One Drop | Premium
First Posted Date
2017-10-19
Last Posted Date
2019-02-26
Lead Sponsor
Informed Data Systems, Inc.
Target Recruit Count
400
Registration Number
NCT03313960
Locations
🇺🇸

One Drop, New York, New York, United States

Improving Post-Prandial Blood Glucose Control With Afrezza During Closed-Loop Therapy

Phase 1
Completed
Conditions
Post-Prandial Hyperglycemia
Post-Prandial Hypoglycemia
Interventions
First Posted Date
2017-07-31
Last Posted Date
2022-05-25
Lead Sponsor
Yale University
Target Recruit Count
15
Registration Number
NCT03234491
Locations
🇺🇸

Yale Diabetes Research Clinic, New Haven, Connecticut, United States

A Study to Identify Biomarkers of Hypoglycaemia in Patients With Type 2 Diabetes

Not Applicable
Completed
Conditions
Type 2 Diabetes Mellitus With Hypoglycemia
Interventions
First Posted Date
2017-04-06
Last Posted Date
2018-11-01
Lead Sponsor
University of Hull
Target Recruit Count
50
Registration Number
NCT03102801
Locations
🇬🇧

Hull and east Yorkshire Hospitals NHS Trust, Hull, United Kingdom

Remission Rate of Newly Diagnosed Type 2 Diabetes Outpatients Treated With Short-term Intensive Insulin Therapy

Phase 4
Completed
Conditions
Type2 Diabetes
Interventions
First Posted Date
2017-01-25
Last Posted Date
2017-01-25
Lead Sponsor
Qianfoshan Hospital
Target Recruit Count
170
Registration Number
NCT03030300
Locations
🇨🇳

Shandong Provincial Hospital, Jinan, Shandong, China

🇨🇳

Qilu Hospital, Jinan, Shandong, China

🇨🇳

Qianfoshan Hospital, Jinan, Shandong, China

Effects of Intranasal Insulin Administration on Tissue Specific Insulin Sensitivity

Not Applicable
Completed
Conditions
Insulin Resistance
Interventions
Drug: Placebo
Radiation: [18F]-FDG PET-CT
Drug: Hyperinsulinemic euglycemic clamp
First Posted Date
2016-10-14
Last Posted Date
2018-01-26
Lead Sponsor
Turku University Hospital
Target Recruit Count
10
Registration Number
NCT02933645
Locations
🇫🇮

Turku PET Centre, Turku, Finland

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