Insulin
Main evidence: Human clinical trials. Updated 2026-10-28.
What research and users report, not a recommendation or medical advice. Many of these products are not approved for human use. Ask your doctor. Packs report what sources say, each with its evidence label. A claim labelled community, educator, manufacturer or animal has not been validated in humans.
Summary
This pack summarizes published evidence, dosing context, safety considerations, and Australian legal status for Insulin.
What the sources say
- In the 18-month CIMT randomized trial in insulin-treated type 2 diabetes, adding metformin reduced HbA1c by an additional 0.42 percentage points and lowered final insulin dose and weight gain versus placebo plus insulin, but non-severe hypoglycaemic episodes were more frequent and carotid intima-media thickness did not improve. This is evidence for that regimen and population, not general insulin "synergy." (Human clinical trials; Lundby-Christensen et al., "Metformin in combination with insulin in patients with type 2 diabetes mellitus" (CIMT trial), 2016-02-25)
- In the DCCT randomized trial in type 1 diabetes, intensive insulin treatment reduced several microvascular complications, including retinopathy and neuropathy, compared with conventional treatment, while increasing severe hypoglycaemia. This supports sustained, medically supervised glycaemic management, not dose escalation or physique-enhancement use. (Human clinical trials; 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", 1993-09-30)
- A T1D Exchange community article recounts people's fear of hypoglycaemia and how it can influence daily decisions, including maintaining higher glucose levels; these personal stories illustrate lived experience, not treatment efficacy or a dose protocol. (Community reports; T1D Exchange, "Living With T1D and Fear of Hypoglycemia: Stories From Our Community", 2025-03-28)
- Insulin includes distinct basal and mealtime products; the Tresiba PI is a product-specific basal example, not a class-wide dose or mixing protocol. (Educator material (not peer reviewed); TGA, Product Information for Tresiba FlexTouch/Penfill insulin degludec (AusPAR attachment), 2018-05-22)
- Hypoglycaemia is a major insulin hazard; in the DCCT, intensive treatment increased severe hypoglycaemia even as it reduced long-term microvascular complications. This underscores the need for individualized clinical monitoring and does not support unsupervised dose changes. (Human clinical trials; 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", 1993-09-30)
- The TGA's October 2026 supply update describes discontinuations and expected changes affecting particular insulin brands and presentations; availability is therefore product- and pack-specific and should be checked at the time of use. (Educator material (not peer reviewed); TGA, "About the changes to the supply of insulin products", 2026-10-26)
- The Tresiba PI says that this insulin is subcutaneous only and warns against intravenous or intramuscular administration and use in infusion pumps; it also requires attention to product strength and presentation. These restrictions are product-specific. (Educator material (not peer reviewed); TGA, Product Information for Tresiba FlexTouch/Penfill insulin degludec (AusPAR attachment), 2018-05-22)
- As checked on 28 October 2026, the TGA ARTG lists NovoRapid insulin aspart 100 U/mL multidose vial, ARTG 133443, with licence status A. This verifies one product presentation only, not every insulin or presentation. (Educator material (not peer reviewed); TGA ARTG entry, "NOVORAPID insulin aspart (rys) 100U/mL injection multidose vial (133443)", 2026-10-28)
- The June 2026 Poisons Standard defines Schedule 4 medicines as prescription-only; this is the legal schedule definition and does not establish current supply or subsidy for a product. (Educator material (not peer reviewed); Australian Government, Therapeutic Goods (Poisons Standard—June 2026) Instrument 2026, 2026-05-28)
- The Tresiba Australian Product Information identifies the named product as Schedule 4 (prescription only); do not infer exact registration or supply status for every insulin from that label. (Educator material (not peer reviewed); TGA, Product Information for Tresiba FlexTouch/Penfill insulin degludec (AusPAR attachment), 2018-05-22)
Sources
- Lundby-Christensen et al., "Metformin in combination with insulin in patients with type 2 diabetes mellitus" (CIMT trial) (2016-02-25)
- 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" (1993-09-30)
- T1D Exchange, "Living With T1D and Fear of Hypoglycemia: Stories From Our Community" (2025-03-28)
- TGA, Product Information for Tresiba FlexTouch/Penfill insulin degludec (AusPAR attachment) (2018-05-22)
- TGA, "About the changes to the supply of insulin products" (2026-10-26)
- TGA ARTG entry, "NOVORAPID insulin aspart (rys) 100U/mL injection multidose vial (133443)" (2026-10-28)
- Australian Government, Therapeutic Goods (Poisons Standard—June 2026) Instrument 2026 (2026-05-28)
Dosing, stacking and protocol details are not published here.