Insulin human

Summary

Insulin human is a recombinant DNA-derived polypeptide identical in amino acid sequence to endogenous human insulin. It is used to control blood glucose in type 1 and type 2 diabetes mellitus. Available in multiple formulations including regular (short-acting) and NPH (intermediate-acting). It replaced animal-sourced insulins and remains a cornerstone of diabetes management worldwide.

Mechanism of Action

Binds to the insulin receptor (a tyrosine kinase receptor) on cell surfaces, activating downstream signaling cascades (PI3K/Akt, MAPK) that promote glucose uptake via GLUT4 translocation in muscle and adipose tissue, suppress hepatic gluconeogenesis, stimulate glycogen synthesis, and inhibit lipolysis.

Routes of Administration

Goals & Uses

• Gestational diabetes managementObstetricsHigh
• Glycemic control in type 1 diabetes mellitusEndocrine / MetabolicHigh
• Management of diabetic ketoacidosis (DKA)Emergency MedicineHigh
• Perioperative glucose controlSurgical / Critical CareHigh
• Hyperkalemia treatmentElectrolyte ManagementHigh
• Glycemic control in type 2 diabetes mellitusEndocrine / MetabolicHigh

Contraindications

• Hypokalemia (uncorrected)ElectrolyteModerate
• Hypersensitivity to insulin human or excipientsImmunologicHigh
• Hypoglycemia (active episode)MetabolicHigh

Adverse Effects

• HypokalemiaElectrolyteUncommon
• HypoglycemiaMetabolicCommonAbnormally low blood glucose
• Peripheral edemaFluid BalanceUncommonSwelling of the arms or legs
• Injection site reactions (lipohypertrophy, lipoatrophy)Local / DermatologicCommon
• Anaphylaxis / systemic allergyImmunologicRare
• Weight gainMetabolicCommonIncrease in body weight

Drug Interactions

• Thiazolidinediones (e.g., pioglitazone)Moderate
• Beta-blockers (non-selective)Moderate
• Salicylates (high dose)Low
• AlcoholModerate
• CorticosteroidsModerate
• ACE inhibitorsLow

Population Constraints

• PregnancyReproductive SafetyRelative
• Hepatic impairmentOrgan FunctionRelative
• Renal impairmentOrgan ImpairmentRelative
• Elderly patientsAgeRelative
• Pediatric patients (neonates)AgeRelative

Regulatory Status

• European UnionApprovedApproved: Diabetes mellitus requiring insulin treatmentApproved by EMA; multiple originator and biosimilar products authorized. Regulated as a biological medicinal product.
• United StatesApprovedApproved: Type 1 diabetes mellitus, Type 2 diabetes mellitus, Gestational diabetesApproved as a biologic by FDA. Reclassified under the BPCI Act in March 2020. Multiple brand and biosimilar products available.
• United KingdomApprovedApproved: Type 1 diabetes mellitus, Type 2 diabetes mellitusApproved by MHRA. Available on NHS; multiple formulations including Humulin and Insulatard listed.

Approved by the FDA, EMA, and most major regulatory agencies. Classified as a biological product in the US under the Biologics Price Competition and Innovation Act (BPCI Act). Biosimilar versions are available. Reclassified from drug to biologic in the US in March 2020.

Evidence & Sources

No sources recorded yet.