{"id":"insulin","name":"Insulin","aliases":["insulin human","Humulin","Novolin","insulin analogues (lispro, aspart, glargine, detemir, degludec)"],"url":"https://lyoresearch.com/compounds/insulin","class":{"id":"endocrine-medicines","name":"Bone and endocrine peptide medicines","url":"https://lyoresearch.com/classes/endocrine-medicines"},"summary":"Insulin is the 51-amino-acid hormone that lets cells take up glucose; recombinant human insulin and its engineered analogues are the treatment for type 1 diabetes and a mainstay of type 2. The landmark trials are settled: intensive insulin therapy cut new diabetic eye disease by 76% over six and a half years in the DCCT, and intensive glucose control reduced microvascular complications by a quarter over ten years in UKPDS. The cost, quantified in the same trials, is severe hypoglycaemia. It is on this site as the reference peptide, and because it is on WADA's list.","overall_grade":"A","overall_grade_meaning":"established in humans","human_trials":"DCCT (n=1,441), UKPDS (n=3,867) and a century of use","regulatory_status":"Approved (Rx)","molecule":{"formula":"C257H383N65O77S6","molecular_weight":"5808","cas":"11061-68-0","pubchem_cid":118984375,"note":"Human insulin; the analogues differ by a few residues"},"pharmacokinetics":{"basis":"label","route":"Subcutaneous injection; intravenous infusion in hospital","half_life":"About 1.5 hours after subcutaneous injection (range 40 minutes to 7 hours); about 20 minutes intravenous","licensed_regimen":"Individualised to the person's metabolic needs, blood glucose monitoring and glycaemic goals; regular insulin is generally used with an intermediate- or long-acting insulin","product":"Humulin R (insulin human)","source":{"title":"Humulin R prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b519bd83-038c-4ec5-a231-a51ec5cc291f"}},"outcomes":[{"outcome":"Diabetic retinopathy (type 1, intensive vs conventional)","grade":"A","grade_meaning":"established in humans","effect_size":"large","adverse":false,"human_studies":"1 large RCT (DCCT, n=1,441, 6.5 yr)","evidence":"Intensive insulin therapy — pump or three or more daily injections with frequent glucose monitoring — reduced new retinopathy by 76% and slowed existing retinopathy by 54%. Kidney and nerve complications fell too.","references":[{"citation":"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.","where":"N Engl J Med, 1993;329:977–986","url":"https://pubmed.ncbi.nlm.nih.gov/8366922/"}],"verbatim":{"text":"In the primary-prevention cohort, intensive therapy reduced the adjusted mean risk for the development of retinopathy by 76 percent (95 percent confidence interval, 62 to 85 percent), as compared with conventional therapy.","citation":"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.","url":"https://pubmed.ncbi.nlm.nih.gov/8366922/"}},{"outcome":"Microvascular complications (type 2)","grade":"A","grade_meaning":"established in humans","effect_size":"moderate","adverse":false,"human_studies":"1 large RCT (UKPDS 33, n=3,867, 10 yr)","evidence":"Intensive glucose control with insulin or a sulphonylurea cut microvascular endpoints by 25% over ten years in newly diagnosed type 2 diabetes; the effect on heart attacks and deaths did not reach significance in the main trial, though it emerged in the ten-year follow-up.","references":[{"citation":"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).","where":"Lancet, 1998;352:837–853","url":"https://pubmed.ncbi.nlm.nih.gov/9742976/"}],"verbatim":{"text":"Most of the risk reduction in the any diabetes-related aggregate endpoint was due to a 25% risk reduction (7-40, p=0.0099) in microvascular endpoints, including the need for retinal photocoagulation.","citation":"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).","url":"https://pubmed.ncbi.nlm.nih.gov/9742976/"}},{"outcome":"Severe hypoglycaemia","grade":"A","grade_meaning":"established in humans","effect_size":"large","adverse":true,"human_studies":"Both landmark RCTs","evidence":"The defining harm. Intensive therapy in the DCCT roughly tripled severe hypoglycaemia; in UKPDS the rate of major episodes on insulin was 1.8% a year against 0.7% on conventional treatment.","references":[{"citation":"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.","where":"N Engl J Med, 1993;329:977–986","url":"https://pubmed.ncbi.nlm.nih.gov/8366922/"},{"citation":"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).","where":"Lancet, 1998;352:837–853","url":"https://pubmed.ncbi.nlm.nih.gov/9742976/"}],"verbatim":{"text":"The chief adverse event associated with intensive therapy was a two-to-threefold increase in severe hypoglycemia.","citation":"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.","url":"https://pubmed.ncbi.nlm.nih.gov/8366922/"}},{"outcome":"Weight gain","grade":"A","grade_meaning":"established in humans","effect_size":"small","adverse":true,"human_studies":"UKPDS and many","evidence":"Intensive treatment added about 2.9 kg over ten years in UKPDS — the reason insulin is the wrong tool for anyone seeking to lose weight and one reason the GLP-1 drugs exist.","references":[{"citation":"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).","where":"Lancet, 1998;352:837–853","url":"https://pubmed.ncbi.nlm.nih.gov/9742976/"}]}],"regions":[{"region":"European Union","status":"Approved, prescription-only","note":"Human insulins and analogues centrally authorised; some countries allow pharmacy sale of human insulin without prescription."},{"region":"United States","status":"Approved; some human insulins available without prescription","note":"Analogues are prescription-only. Human regular and NPH insulin (Humulin, Novolin) can be sold over the counter in most states. In 2026 the FDA approved two once-weekly basal insulins for adults with type 2 diabetes: Awiqli (insulin icodec) on 26 March and Onswik (insulin efsitora alfa) on 23 September."},{"region":"United Kingdom","status":"Licensed, prescription-only","note":"All insulins are prescription-only medicines."},{"region":"Australia","status":"Registered, Schedule 4","note":"Prescription-only; PBS-subsidised."},{"region":"Canada","status":"Authorised; human insulin available without prescription","note":"Human insulins are Schedule II (behind the counter, no prescription); analogues vary."},{"region":"Sport (WADA)","status":"Prohibited at all times","note":"Insulins are listed under S4 (hormone and metabolic modulators), in and out of competition; a therapeutic use exemption is required for athletes with diabetes."}],"faq":[{"q":"Why is insulin on a peptide reference site?","a":"Because it is the original peptide medicine, the standard every other evidence page is measured against, and a compound misused outside medicine for muscle gain — which is why sport bans it."},{"q":"Is insulin a peptide?","a":"Yes — 51 amino acids in two chains, technically a small protein. It was the first protein sequenced (1951) and the first made by recombinant DNA (1982)."},{"q":"What is the main danger?","a":"Hypoglycaemia: too much insulin for the food eaten drops blood sugar to levels that cause confusion, seizures and death. Every landmark trial that improved outcomes with tighter control also increased severe hypoglycaemia."}],"references":[{"cite":"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.","where":"N Engl J Med, 1993;329:977–986","url":"https://pubmed.ncbi.nlm.nih.gov/8366922/","note":"1,441 patients, mean 6.5 years."},{"cite":"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).","where":"Lancet, 1998;352:837–853","url":"https://pubmed.ncbi.nlm.nih.gov/9742976/","note":"3,867 newly diagnosed patients, 10 years."},{"cite":"Humulin R (insulin human) prescribing information.","where":"DailyMed","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b519bd83-038c-4ec5-a231-a51ec5cc291f","note":"Pharmacokinetics and description."},{"cite":"FDA. Novel Drug Approvals for 2026 (Awiqli, insulin icodec-abae, 26 March 2026; Onswik, insulin efsitora alfa-gobe, 23 September 2026).","where":"FDA, read 7 Oct 2026","url":"https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026","note":"Both approved to improve glycaemic control in adults with type 2 diabetes."}],"last_reviewed":"2026-10-07","literature_searched_to":"2026-10-07","changelog":[{"date":"2026-10-07","note":"US row: the two once-weekly basal insulins approved by the FDA in 2026 (Awiqli, 26 March; Onswik, 23 September) added. Grades unchanged."},{"date":"2026-09-23","note":"Initial publication as the reference peptide. Grade A on DCCT and UKPDS."}],"license":"CC BY 4.0 — cite as “LYO Research” with a link.","methodology":"https://lyoresearch.com/methodology"}