Insulin (Regular Human)

Insulin — Recombinant Human Insulin (Regular, rDNA Origin)

Evidence & Status

  • FDA Approved
  • Strong Human Evidence
  • Strong

FDA Approval Scope

HUMULIN R U-100 is the product anchor for recombinant regular human insulin in this record; route, concentration, dosing, and monitoring information are product- and indication-specific.

At a Glance

Recombinant regular human insulin is an established medical therapy for diabetes. This record uses HUMULIN R U-100 as a product anchor, keeps it distinct from insulin analogues, and emphasizes individualized dosing and glucose monitoring.

Plain English

Regular human insulin is the recombinant form of the hormone the pancreas makes to regulate blood glucose. HUMULIN R U-100 is a specific product, and its instructions should not be mixed with those for faster or longer-acting insulin analogues. Doses are individualized because too much insulin can cause severe hypoglycemia.

Overview

This record primarily represents recombinant regular human insulin, a 51-amino-acid two-chain hormone that is biochemically identical to endogenous human insulin. HUMULIN R U-100 is the current U.S. product anchor; its labeled information must remain distinct from endogenous physiology, rapid-acting or basal analogues, inhaled insulin, and concentrated or otherwise non-equivalent products. Established medical use does not make athletic or anabolic use a benefit.

Research Summary

The DCCT was a landmark randomized study of intensive insulin treatment in type 1 diabetes and supports the clinical importance of glycemic control in that studied population. It is not a HUMULIN R U-100 label and does not support every regular-insulin dose or route claim. Current HUMULIN R U-100 labeling supports product-specific SC and IV use where permitted, individualized dosing, glucose monitoring, and risks including hypoglycemia, hypokalemia, and hypersensitivity. The strong evidence rating is scoped to established medical use of regular human insulin.

Research Areas

  • Type 1 diabetes
  • Type 2 diabetes
  • Glucose homeostasis
  • Insulin resistance
  • Critical care glycemic control
  • Regular human insulin product pharmacology

Safety & Risks

Serious Risks

  • Severe hypoglycemia — potentially fatal; risk is highest with dose-food-activity mismatch
  • Hypoglycemic coma or seizure
  • Hypokalemia with IV insulin (intracellular K+ shift)
  • Anaphylaxis (rare; historically more common with animal-derived formulations)
  • Acute mortality risk from off-label athletic misuse due to unpredictable hypoglycemia in non-diabetic individuals

Reported Side Effects

  • Hypoglycemia (most common, dose-dependent)
  • Weight gain
  • Injection site lipohypertrophy
  • Injection site reactions (redness, swelling)
  • Peripheral edema (early treatment)
  • Hypokalemia (with IV administration)
United States
HUMULIN R U-100 is an FDA-approved recombinant regular human insulin product; route, concentration, prescription status, and use are product- and jurisdiction-specific.
United Kingdom
Product- and jurisdiction-specific insulin authorization and prescription status are not fully represented by the selected sources in this record.
Australia
Product- and jurisdiction-specific insulin authorization and prescription status are not fully represented by the selected sources in this record.
Canada
Product- and jurisdiction-specific insulin authorization and prescription status are not fully represented by the selected sources in this record.

Citations & Sources