Insulin

Dosing from the Literature

Published for diabetes: individual doses set by glucose monitoring, under a clinician. Not published: any safe dose for building muscle.

The labels individualize the dose to the patient's metabolic needs, blood glucose monitoring and glycemic goal, with changes made under medical supervision (Lantus label). The starting doses below come from the labels, the ADA Standards of Care and two published papers, each named in its row.

What It Is

Insulin is a 51-amino-acid peptide hormone synthesized by the β-cells of the pancreatic islets of Langerhans. Its mature form consists of two polypeptide chains — an A-chain of 21 amino acids and a B-chain of 30 amino acids — held together by two interchain disulfide bonds, with a third intrachain disulfide within the A-chain. The hormone is produced as a single-chain precursor (preproinsulin → proinsulin) that is subsequently cleaved; the C-peptide fragment removed during maturation is widely used in clinical medicine as a marker of endogenous insulin production.

Insulin was first isolated and purified from canine pancreatic tissue in 1921 by Frederick Banting, Charles Best, J.J.R. Macleod, and James Collip at the University of Toronto. The 1922 treatment of 14-year-old Leonard Thompson with bovine pancreatic extract is widely regarded as the first successful pharmacologic rescue of a previously-universally-fatal disease (type 1 diabetes). Banting and Macleod received the 1923 Nobel Prize in Physiology or Medicine — one of the fastest "bench to Nobel" timelines in the history of the award. Recombinant human insulin (Humulin) was approved in 1982, the first therapeutic produced from recombinant DNA technology.

The modern insulin pharmacopeia includes multiple formulations tuned for different kinetic profiles: rapid-acting analogs (lispro [Humalog], aspart [Novolog], glulisine [Apidra]) with onset in 10–15 minutes and duration of 3–5 hours, and ultra-rapid aspart [Fiasp], whose effect lasts about 5–7 hours, depending on dose (Fiasp label); short-acting regular human insulin (Humulin R, Novolin R) with onset at 30 minutes and duration of 6–8 hours; intermediate-acting NPH (neutral protamine Hagedorn) with duration of 12–18 hours; and long-acting analogs (glargine U-100 and U-300 [Lantus, Toujeo], detemir [Levemir], degludec [Tresiba]) with peakless profiles and durations of 24 hours (glargine, detemir) to 42+ hours (degludec).

Insulin is the cornerstone of type 1 diabetes management (where endogenous production is absent) and is added to advanced type 2 diabetes regimens when oral agents and GLP-1 / GIP-class therapies are insufficient. Insulin remains irreplaceable in diabetic ketoacidosis, hyperosmolar hyperglycemic state, inpatient hyperglycemia management, and perioperative glycemic control. It is also one of the most dangerous drugs in modern medicine — misuse or miscalculation produces hypoglycemia that can cause seizures, brain injury, coma, and death within minutes.

Mechanism of Action

Insulin acts by binding a receptor on the cell surface, the insulin receptor (IR); activation of the receptor's kinase is believed to generate the signal behind insulin's effects on glucose, lipid and protein metabolism (Kahn, 1985).

• Insulin receptor (IR) activation — IR is a cell-surface glycoprotein with an α-subunit, which binds insulin, and a β-subunit, which is an insulin-stimulated tyrosine kinase (Kahn, 1985).
• Glucose uptake (muscle + adipose) — Insulin lowers blood glucose by stimulating glucose uptake by skeletal muscle and fat (Humalog label).
• Hepatic glucose output suppression — Insulin inhibits the liver's glucose production (Humalog label); restraining it overnight and between meals is the principal action of basal insulin (ADA Standards of Care, 2025).
• Anabolic / protein synthesis — Insulin enhances protein synthesis and inhibits proteolysis, the breakdown of protein (Humalog label).
• Lipolysis suppression — Insulin inhibits lipolysis, the release of stored fat (Humalog label).
• K⁺ shift into cells — Insulin shifts potassium from outside cells to inside them, which can cause hypokalemia; untreated, that may cause respiratory paralysis, ventricular arrhythmia and death (Humalog label). The same shift is used, with glucose, to lower potassium in emergency hyperkalemia (Harel & Kamel, 2016).
• IGF-1 receptor cross-talk — Insulin's growth-promoting effects appear to run through receptors for the related insulin-like growth factors (Kahn, 1985).

What the Research Shows

Insulin has one of the deepest evidence bases of any pharmaceutical — over a century of continuous clinical use, thousands of RCTs, and comprehensive pharmacovigilance. The research base is unambiguous for diabetes management; it is functionally absent for non-diabetic performance use.

• DCCT (Diabetes Control and Complications Trial, NEJM 1993, PMID 8366922) — 1,441 type 1 diabetics randomized to intensive vs conventional insulin therapy. Intensive therapy (three or more daily injections, or a pump) reduced the risk of developing retinopathy by 76% in those without it at baseline and slowed its progression by 54% in those with mild retinopathy; it cut microalbuminuria by 39% and clinical neuropathy by 60% over a mean 6.5 years. Foundational evidence for tight glycemic control in T1D.
• UKPDS (UK Prospective Diabetes Study, Lancet 1998, PMID 9742976) — ~3,867 newly diagnosed T2D patients assigned to intensive (sulfonylurea/insulin) vs conventional therapy. Intensive therapy reduced microvascular complications by 25% at 10-year median follow-up.
• ORIGIN trial (Gerstein et al., NEJM 2012, PMID 22686416) — 12,537 dysglycemic patients at CV risk randomized to insulin glargine targeting fasting glucose ≤95 mg/dL vs standard care. Median 6.2-year follow-up. Glargine was neutral for CV outcomes; suggested tight glycemic control without macrovascular benefit in this population.
• DEVOTE trial (Marso et al., NEJM 2017, PMID 28605603) — 7,637 T2D patients with high CV risk randomized to degludec vs glargine U100. Non-inferior for MACE; degludec reduced overall and nocturnal severe hypoglycemia by ~40%.
• BEGIN / ONSET / STEP programs — Multiple pivotal trial programs for the modern basal and rapid analogs, establishing comparative hypoglycemia and HbA1c profiles for glargine U300, degludec, ultra-rapid aspart, and other agents.
• Insulin receptor pharmacology (Kahn, Rosen reviews) — Decades of receptor-level molecular biology establish IR signaling, GLUT4 biology, and IRS-PI3K-Akt cascade as foundational endocrine pharmacology.
• Insulin misuse case reports — A published case report describes the dangers of insulin misuse in bodybuilding and notes that such misuse was then undetectable by available tests (Evans & Lynch, Br J Sports Med 2003); a 1997 BMJ letter is titled "Bodybuilders find it easy to obtain insulin to help them in training" (Elkin et al., BMJ 1997).
• Hypoglycemia lethality data — The ACCORD trial (NEJM 2008) found excess mortality in the intensive-glycemic-control arm of T2D patients, likely partially attributable to severe hypoglycemia — a cautionary signal even in closely-monitored patients.
• Performance research — No RCT evaluating insulin in healthy athletes exists. The practice is banned by the World Anti-Doping Agency (WADA Section S4, Hormone and Metabolic Modulators), and human subjects ethics boards would not approve a controlled trial given the fatality risk.

Human Data

Insulin has been administered to hundreds of millions of patients since 1922. The clinical dataset is vast; only the most pivotal studies are listed here.

• Banting & Best (1921–1922) — Isolation of insulin from canine pancreatic extract and first successful human treatment (Leonard Thompson, January 1922). Foundational discovery paper Banting & Best, J Lab Clin Med 1922.
• Humulin approval (1982) — First recombinant DNA-derived therapeutic approved by the FDA, introducing human-sequence insulin and ending clinical dependence on bovine and porcine pancreas extracts.
• DCCT (1993; PMID 8366922) — Established intensive insulin therapy as standard of care in T1D. Demonstrated that tight glycemic control reduces long-term microvascular complications.
• EDIC follow-up (Writing Team, JAMA 2002; PMID 12020338) — The Epidemiology of Diabetes Interventions and Complications observational follow-up of DCCT patients showed the benefits of intensive control persist for years after the randomized period (the "legacy effect" or "metabolic memory").
• UKPDS 33 + 34 (1998) — Established tight glycemic control as standard in T2D. Metformin arm (UKPDS 34) defined metformin's role as the first-line oral agent.
• Rapid analog pivotal trials (lispro: Anderson et al., Diabetes Care 1997; aspart: Lindholm et al., Diabetes Care 1999) — Established the rapid analogs' reduced post-prandial excursion and lower late-post-prandial hypoglycemia vs regular insulin.
• Glargine (HOE901) pivotal program (Rosenstock et al., Diabetes Care 2001) — Demonstrated glargine's peakless basal profile and reduced nocturnal hypoglycemia vs NPH.
• Detemir and degludec development — Further basal analog iterations with extended duration and reduced day-to-day pharmacokinetic variability.
• ORIGIN (2012) — Large CV outcome trial of insulin glargine in dysglycemic high-CV-risk patients; neutral MACE, no excess cancer signal.
• DEVOTE (2017) — Cardiovascular safety confirmation for degludec and demonstration of reduced hypoglycemia vs glargine U100.
• Inhaled insulin (Afrezza, 2014) — FDA-approved rapid-acting inhaled human insulin; niche use.
• Insulin pumps and closed-loop systems — Automated insulin delivery systems (Medtronic 670G, Tandem Control-IQ, Omnipod 5) deliver insulin continuously under the skin, adjusted by CGM readings; the ADA Standards of Care (2025) make them the preferred insulin delivery method for youth and adults with type 1 diabetes who can use them.

Reconstitution & Storage

Insulin is supplied ready to use in vials, cartridges and prefilled pens, as a solution (NPH as a suspension); nothing is reconstituted. Most products are U-100 (100 units/mL); Humalog and Tresiba also come as U-200, Toujeo as U-300, and Humulin R as U-500 for people needing more than 200 units a day (Humalog, Tresiba, Toujeo and Humulin R U-500 labels). Afrezza is an inhaled powder in single-use cartridges (Afrezza label).

• Injection technique — The labels list subcutaneous injection into the abdomen, thigh, upper arm or buttocks, rotating sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis (Humalog label). The ADA Standards of Care (2025) cite evidence that short needles, such as 4-mm pen needles, are effective and well tolerated compared with longer ones.
• Mixing in a syringe — The Lantus, Toujeo and Tresiba labels say not to dilute or mix these basal insulins with any other insulin or solution; Humalog U-100 and Novolog may be mixed only with NPH insulin, and Humulin R only with Humulin N (Lantus, Toujeo, Tresiba, Humalog, Novolog, Humulin R labels).
• Temperature — The labels say not to freeze insulin or use it after it has been frozen, to protect it from heat and light, and give room-temperature limits of up to 30°C (25°C for Apidra and for Novolin R and N vials) (Humalog, Apidra, Novolin R, Novolin N labels).
• Inspection — Rapid-acting, regular and long-acting insulins are clear, colorless solutions; NPH is uniformly white and cloudy after mixing, and the Humulin N instructions say not to use it if it looks clear or has lumps or particles (Humalog, Humulin R, Lantus, Humulin N labels).
• Pump-compatible insulins — Humalog U-100, Novolog, Apidra and Fiasp are labeled for insulin pumps. The Novolin R label does not recommend pump use because of the risk of precipitation, and the long-acting and NPH insulins are labeled not for pumps (Humalog, Novolog, Apidra, Fiasp, Novolin R, Lantus, Tresiba, Humulin N labels).

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Side Effects & Risks

The insulin labels list hypoglycemia as the most common adverse reaction (Humalog label).

• Hypoglycemia — potentially fatal — Severe hypoglycemia can cause seizures, may be life-threatening or cause death, and hypoglycemia can come on suddenly. Signs include sweating, shakiness and confusion; severe episodes bring coma, seizures or neurologic impairment, and hypoglycemia can return after apparent recovery (Humalog label). Intensive treatment raised severe hypoglycemia two- to threefold in DCCT (DCCT Research Group, 1993), and in ORIGIN it ran at 1.00 vs 0.31 events per 100 person-years on glargine vs standard care (Gerstein et al., 2012). The ADA Standards of Care (2025) name glucose as the preferred treatment for a conscious person below 70 mg/dL and call for glucagon to be prescribed to everyone taking insulin.
• Weight gain — Can occur with insulin; the labels attribute it to insulin's anabolic effects and to less sugar lost in the urine (Humalog label). In UKPDS, people assigned insulin gained a mean 4.0 kg, more than on chlorpropamide (2.6 kg) or glibenclamide (1.7 kg) (UKPDS Group, 1998); in ORIGIN, median weight rose 1.6 kg on glargine and fell 0.5 kg on standard care (Gerstein et al., 2012).
• Lipohypertrophy / lipoatrophy — Thickening or thinning of fat at repeated injection sites, which may affect insulin absorption; the labels describe rotating sites within the same region to reduce the risk (Humalog label). Lipohypertrophy can contribute to erratic absorption, more variable glucose and unexplained hypoglycemia (ADA Standards of Care, 2025).
• Hypokalemia — All insulins shift potassium into cells, which can lead to hypokalemia; untreated, it may cause respiratory paralysis, ventricular arrhythmia and death (Humalog label). In DKA treatment, the 2024 consensus report gives potassium once levels fall below 5.0 mmol/L and holds insulin until potassium is above 3.5 mmol/L; hypokalemia, a common complication of treatment, occurred in about 55% of people with DKA (Umpierrez et al., 2024).
• Edema (insulin edema) — Insulin may cause sodium retention and edema, particularly when poor control is improved by intensified insulin therapy; with thiazolidinediones, fluid retention can lead to or worsen heart failure (Humalog label).
• Worsening diabetic retinopathy (early) — Intensification or rapid improvement in glucose control has been associated with worsening of diabetic retinopathy, a temporary refraction disorder and acute painful neuropathy; long-term control lowers the risk of retinopathy and neuropathy (Humalog label).
• Allergic reactions — Redness, swelling or itching at the injection site, usually gone within days to weeks; severe, life-threatening generalized allergy, including anaphylaxis, can occur with any insulin (Humalog label).
• Insulin antibodies — All insulins can trigger insulin antibodies, which may raise or lower insulin's effect (Lantus label). In Humalog's large trials, antibody levels rose most in people new to insulin, peaked by 12 months, and did not appear to worsen glucose control or raise doses (Humalog label).
• Cancer (glargine) — In ORIGIN, a randomized trial in 12,537 people with dysglycemia and cardiovascular risk factors, cancer rates did not differ between insulin glargine and standard care over a median 6.2 years (hazard ratio 1.00) (Gerstein et al., 2012).
• Hypoglycemia unawareness — Awareness of hypoglycemia symptoms may be weaker in people with long-standing diabetes or diabetic nerve disease, in those taking beta-blockers, and in those who have repeated hypoglycemia (Humalog label).
• Drug interactions — Beta-blockers, clonidine, guanethidine and reserpine may blunt the warning signs of hypoglycemia; alcohol, beta-blockers, clonidine and lithium may raise or lower insulin's glucose-lowering effect; corticosteroids, atypical antipsychotics, diuretics and somatropin, among others, may weaken it, so doses may need raising; other diabetes drugs, ACE inhibitors, fluoxetine and salicylates, among others, may raise the risk of hypoglycemia (Humalog label).
• Performance / bodybuilding use (critical) — A published case report describes the dangers of insulin misuse in bodybuilding (Evans & Lynch, 2003). No label gives a dose for use outside diabetes, and the labels warn that severe hypoglycemia can cause seizures and death (Humalog label).

Bloodwork & Monitoring

• Blood glucose — The labels set the dose by blood glucose monitoring and call for more frequent monitoring whenever the insulin regimen changes (Lantus label).
• Continuous glucose monitoring (CGM) — The ADA Standards of Care (2025) recommend CGM for youth and adults on any type of insulin therapy, and offering it in type 1 diabetes from diagnosis; they call for CGM users to keep access to a fingerstick meter at all times.
• HbA1c — Reflects average glucose over about 2–3 months. The ADA Standards of Care (2025) assess glycemic status at least twice a year, and about every 3 months after treatment changes or when goals are not met; their A1C goal for many nonpregnant adults is <7%, without frequent or severe hypoglycemia.
• Time-in-range (CGM metric) — Percentage of time glucose is 70–180 mg/dL; the ADA Standards of Care (2025) set a goal above 70% for many nonpregnant adults using CGM (above 50% for older adults).
• C-peptide — A marker of the body's own insulin output: low or undetectable in established type 1 diabetes, and used to help classify diabetes in adults on insulin when type 1 is suspected (ADA Standards of Care, 2025).
• Potassium — The labels call for monitoring potassium in people at risk of hypokalemia, and closely during intravenous insulin (Humalog, Humulin R labels); in DKA, the 2024 consensus report measures it 2 hours after insulin starts and every 4 hours until the ketoacidosis resolves (Umpierrez et al., 2024).
• Hypoglycemia — The ADA Standards of Care (2025) review hypoglycemia history at every visit for people at risk, list hypoglycemia among the signs of possible overbasalization (too much basal insulin), and note that U-300 glargine and degludec carry a lower risk of nocturnal hypoglycemia than U-100 glargine.

Commonly Stacked With

In type 2 diabetes, the ADA Standards of Care (2025) keep metformin, SGLT2 inhibitors and GLP-1 receptor agonists going when insulin is intensified, unless side effects or contraindications intervene. The last two cards describe bodybuilding use.

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References

1. Banting FG, Best CH. The internal secretion of the pancreas. J Lab Clin Med. 1922;7(5):251-266. (Foundational discovery of insulin.)
2. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329(14):977-986. PMID: 8366922.
3. Writing Team for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Effect of intensive therapy on the microvascular complications of type 1 diabetes mellitus. JAMA. 2002;287(19):2563-2569. PMID: 12020338.
4. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352(9131):837-853. PMID: 9742976.
5. Gerstein HC, Bosch J, Dagenais GR, et al; ORIGIN Trial Investigators. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med. 2012;367(4):319-328. PMID: 22686416.
6. Marso SP, McGuire DK, Zinman B, et al; DEVOTE Study Group. Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes. N Engl J Med. 2017;377(8):723-732. PMID: 28605603.
7. Anderson JH Jr, Brunelle RL, Koivisto VA, et al. Reduction of postprandial hyperglycemia and frequency of hypoglycemia in IDDM patients on insulin-analog treatment. Multicenter Insulin Lispro Study Group. Diabetes. 1997;46(2):265-270. PMID: 9000704.
8. Rosenstock J, Schwartz SL, Clark CM Jr, Park GD, Donley DW, Edwards MB. Basal insulin therapy in type 2 diabetes: 28-week comparison of insulin glargine (HOE 901) and NPH insulin. Diabetes Care. 2001;24(4):631-636. PMID: 11315821.
9. Biolo G, Tipton KD, Klein S, Wolfe RR. An abundant supply of amino acids enhances the metabolic effect of exercise on muscle protein. Am J Physiol. 1997;273(1 Pt 1):E122-E129. PMID: 9252488.
10. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008;359(15):1577-1589. PMID: 18784090. (UKPDS legacy follow-up.)
11. Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes (ACCORD). N Engl J Med. 2008;358(24):2545-2559. PMID: 18539917.
12. Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003;26(11):3080-3086. PMID: 14578243.
13. Elkin SL, Brady S, Williams IP. Bodybuilders find it easy to obtain insulin to help them in training. BMJ. 1997;314(7090):1280. PMID: 9154050.
14. Evans PJ, Lynch RM. Insulin as a drug of abuse in body building. Br J Sports Med. 2003;37(4):356-357. PMID: 12893725.
15. Dandona P, Chaudhuri A, Ghanim H, Mohanty P. Insulin as an anti-inflammatory and antiatherogenic modulator. J Am Coll Cardiol. 2009;53(5 Suppl):S14-S20. PMID: 19179212.
16. Kahn CR. The molecular mechanism of insulin action and the regulation of glucose and lipid metabolism. Annu Rev Med. 1985;36:429-451. PMID: 2986528.
17. American Diabetes Association Professional Practice Committee. Standards of Care in Diabetes—2025. Diabetes Care. 2025;48(Suppl 1):S1-S352.
18. Garber AJ, Handelsman Y, Grunberger G, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm — 2020 executive summary. Endocr Pract. 2020;26(1):107-139. PMID: 32022600.
19. World Anti-Doping Agency. 2026 Prohibited List — Section S4: Hormone and Metabolic Modulators. wada-ama.org.
20. U.S. Food and Drug Administration. Humulin, Humalog, Novolog, Lantus, Toujeo, Levemir, Tresiba prescribing information. FDA.gov.
21. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act (503A categories list), versions updated April 15, April 22 and May 14, 2026. fda.gov/media/94155/download. Read October 3, 2026. (Notice that 12 peptides would leave Category 2 because their nominations were withdrawn; their removal; GHK-Cu, except injectable, back in Category 1.)
22. Umpierrez GE, Davis GM, ElSayed NA, et al. Hyperglycemic crises in adults with diabetes: a consensus report. Diabetes Care. 2024;47(8):1257-1275. PMID: 39052901.
23. Harel Z, Kamel KS. Optimal dose and method of administration of intravenous insulin in the management of emergency hyperkalemia: a systematic review. PLoS One. 2016;11(5):e0154963. PMID: 27148740.
24. Zucchini S, Iafusco D, Vannelli S, et al. Combined therapy with insulin and growth hormone in 17 patients with type-1 diabetes and growth disorders. Horm Res Paediatr. 2014;82(1):53-58. PMID: 24925520.
25. Novo Nordisk. Novolin R (insulin human) injection prescribing information. DailyMed set ID aee7f1f3-612c-4027-8ce9-4fd1f41eed71 (version effective November 23, 2022). dailymed.nlm.nih.gov. Read October 4, 2026.
26. Novo Nordisk. Novolin N (insulin isophane human) injectable suspension prescribing information. DailyMed set ID 82f1445c-b2c6-445a-82cf-ba8825fac776 (version effective November 23, 2022). dailymed.nlm.nih.gov. Read October 4, 2026.
27. Sanofi-Aventis U.S. Apidra (insulin glulisine) injection prescribing information. DailyMed set ID e7af6a7a-8046-4fb4-9979-4ec4230b23aa (version effective November 25, 2025). dailymed.nlm.nih.gov. Read October 4, 2026.
28. Novo Nordisk. Fiasp (insulin aspart) injection prescribing information. DailyMed set ID 834e7efc-393f-4c55-9125-628562a8a5cf (version effective June 21, 2023). dailymed.nlm.nih.gov. Read October 4, 2026.
29. MannKind Corporation. Afrezza (insulin human) inhalation powder prescribing information. DailyMed set ID 29f4637b-e204-425b-b89c-7238008d8c10 (version effective May 30, 2026). dailymed.nlm.nih.gov. Read October 4, 2026.
30. World Anti-Doping Agency. Prohibited List 2027 (in effect January 1, 2027), French edition with track changes, August 26, 2026, and Summary of Major Modifications and Explanatory Notes, 2027 Prohibited List, August 17, 2026: wada-ama.org/sites/default/files/2026-09/2027list_final_fr_track_changes_26_august_2026.pdf and 2027_list_explanatory_note_en_final_17_august_2026_1.pdf, read October 12, 2026 in the Internet Archive’s copies captured October 9, 2026 (web.archive.org). The List’s English edition was not available there and was not read.

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