Is Insulin Glargine safe?
Insulin Glargine
Insulin glargine (Lantus, Toujeo, Basaglar, Semglee) is a long-acting insulin with 25 years of use and no boxed warning. It is essential for people with type 1 diabetes. Its risk is low blood sugar, which can be severe, and the margin for dosing mistakes is narrow.
- Brands
- Lantus, Toujeo (300 units/mL), Basaglar, Semglee
- Starting dose, type 2 (Lantus label)
- 0.2 units/kg or up to 10 units once a day
- Starting dose, type 1 (Lantus label)
- About one third of the total daily insulin dose
- Severe hypoglycaemia, ORIGIN trial
- 5.6% vs 1.8% on standard care over 6.2 years
- US emergency visits
- About 97,600 a year for insulin-related low blood sugar and errors (2007 to 2011)
- Boxed warning
- None
- Controlled substance
- No
- On the market
- US since April 2000
How the score breaks down
The overall score is the weighted average of these factors. Scoring rules
Serious side effects30% of score
50 out of 100, WeakSevere low blood sugar needing another person's help hit 6.5% to 10.6% of adults with type 1 diabetes in 16 to 28 week trials, and 23% of children in a 26-week study (Lantus label). The label also lists low potassium and anaphylaxis.
Overdose margin20% of score
30 out of 100, PoorNarrow. Too much insulin causes hypoglycaemia that can lead to seizures, coma or death. US emergency departments saw about 97,600 visits a year for insulin-related hypoglycaemia and errors, and almost a third led to admission (JAMA Internal Medicine, 2014).
Interactions15% of score
55 out of 100, FairThe label lists many drugs that raise or lower its effect, including other diabetes drugs, ACE inhibitors, steroids and some antipsychotics. Alcohol can push blood sugar either way, and beta-blockers can hide the warning signs of a low.
Dependence and misuse15% of score
90 out of 100, ExcellentNot controlled and no Drug dependenceThe body's adaptation to a drug taken regularly, so that stopping it suddenly causes withdrawal symptoms. It is not the same as addiction.More in the glossary. People with type 1 diabetes need insulin to live, which is a medical need rather than dependence. Deliberate misuse is rare.
Regulatory warnings10% of score
80 out of 100, GoodNo Boxed warningThe strongest safety warning the US FDA puts on a medicine's label, printed inside a black border at the top.More in the glossary. Label warnings cover mix-ups between insulin products and never sharing pens. The MHRA has issued guidance on high-strength insulin errors (2015) and lumps at injection sites (2020); a 2009 cancer concern was not confirmed.
Track record10% of score
92 out of 100, ExcellentApproved in the US in April 2000 and used by millions since. The ORIGIN trial followed 12,537 people for a median 6.2 years and found no difference in heart events or cancer versus standard care.
Is insulin glargine safe?
Yes, when the dose is right, and for many people with diabetes it is not optional. Insulin glargine is a long-acting "basal" insulin injected once a day. It has been sold in the US since April 2000, first as Lantus, and later as the stronger Toujeo and biosimilar versions such as Basaglar and Semglee. It has no Boxed warningThe strongest safety warning the US FDA puts on a medicine's label, printed inside a black border at the top.More in the glossary, and a six-year trial of 12,537 people found no extra heart or cancer risk.
The catch is the one every insulin shares: it lowers blood sugar whether or not you have eaten. Too much causes hypoglycaemia, which can lead to seizures or coma. That is why it scores 60, below tablets like metformin (80) that rarely cause lows on their own. A lower score here does not mean anyone should avoid or stop insulin they need; it reflects how carefully it has to be used.
How common is low blood sugar on glargine?
Very common in mild form, and not rare in severe form. The Lantus label counts "severe symptomatic hypoglycaemia", meaning an episode where someone else had to help:
| Group (Lantus label) | Glargine | Comparison |
|---|---|---|
| Adults, type 1, 16 to 28 weeks | 6.5% to 10.6% | 5.2% to 15.0% on NPH insulin |
| Children, type 1, 26 weeks | 23.0% | 28.6% on NPH |
| Type 2, 52 weeks with tablets | 1.7% | 1.1% on NPH |
| ORIGIN, early type 2, 6.2 years | 5.6% | 1.8% on standard care |
Rates are similar to older NPH insulin, so glargine is not a low-risk exception. In the US, insulin-related lows and errors led to about 97,600 emergency visits a year between 2007 and 2011, and almost a third of those people were admitted (Geller and colleagues, JAMA Internal Medicine, 2014). People aged 80 and over were nearly five times as likely to be admitted as those aged 45 to 64.
Mix-ups and dosing errors
The same study found that the most common triggers were eating less than usual and injecting the wrong insulin. The label warns about this directly: check the label every time. Common traps:
- Lantus vs Toujeo. Toujeo has 300 units/mL, Lantus 100 units/mL. The Lantus label says to start at 80% of the Toujeo dose when switching.
- Basal vs mealtime insulin. Injecting a full dose of a rapid-acting insulin instead of glargine at bedtime can cause a severe night-time low.
- Biosimilar switches. A change of brand, strength or device needs closer glucose checks for the first weeks, the label says.
Glargine must not be mixed with other insulins, diluted, used in a pump or injected into a vein. Pens must never be shared, even with a new needle, because of the risk of blood-borne infection.
Interactions that change your dose
Insulin interacts with physiology more than with specific chemistry, so the list is long. The label groups the main ones:
- Can push sugar down: other diabetes drugs (including semaglutide and tirzepatide), ACE inhibitors and ARBs, fluoxetine, fibrates, salicylates, sulfonamide antibiotics.
- Can push sugar up: steroids such as prednisone, diuretics, olanzapine and clozapine, thyroid hormone, oral contraceptives, salbutamol (albuterol).
- Either way: alcohol, beta-blockers, clonidine, lithium.
- Hide the warning signs: beta-blockers and clonidine can blunt shaking and a racing heart.
Supplements sold for blood sugar, such as berberine, can add to the effect; tell your prescriber about them.
How to stay safe
- Inject at the same time each day into the abdomen, thigh or upper arm, and rotate sites within the same area. The MHRA warned in 2020 that injecting into lumpy areas (lipodystrophy or amyloid deposits) can stop insulin working well, and switching suddenly to fresh skin can then cause a low.
- Carry fast-acting glucose and make sure family know how to use emergency glucagon.
- Check glucose more often when you are ill, exercising more, drinking alcohol, or starting or stopping other medicines.
- Glargine is not a treatment for diabetic ketoacidosis.
- Talk to your doctor or pharmacist before changing brand, strength or timing.
How we scored it
Track record (92) and regulatory warnings (80) are strong: 25 years of use, large outcome trials and no Boxed warningThe strongest safety warning the US FDA puts on a medicine's label, printed inside a black border at the top.More in the glossary. Dependence (90) is not a concern. The score is pulled down by Overdose marginHow far a normal dose is from a harmful one. A wide margin means an accidental extra dose is unlikely to cause serious harm.More in the glossary (30), because a modest excess can cause a dangerous low, by frequent serious side effects (50) in the form of severe hypoglycaemia, and by the long list of interactions (55).
Questions people ask
Does insulin glargine cause cancer?
The evidence says no. Observational studies in 2009 raised the question, and European regulators made no change to its use. The ORIGIN trial, which followed about 12,500 people for a median of 6.2 years, found the same rate of new cancers with glargine as with standard care.
Are Lantus and Toujeo the same?
Both are insulin glargine, but Toujeo is three times as concentrated (300 units/mL vs 100 units/mL) and the doses are not interchangeable unit for unit. The Lantus label says people switching from Toujeo should start at 80% of their Toujeo dose. Any switch should be guided by your prescriber, with more frequent glucose checks.
What should I do if I injected too much insulin glargine?
Check your blood sugar often, eat fast-acting carbohydrate if it is low, and tell someone. Because glargine acts for about a day, lows can come back hours later. If you cannot keep blood sugar up, feel confused or cannot eat, call emergency services; in the US, Poison Help is 1-800-222-1222.
Can I mix Lantus with other insulin in the same syringe?
No. The label says not to dilute or mix it with any other insulin or solution, and not to use it in an insulin pump or inject it into a vein.
Can I stop insulin glargine if my sugars are good?
Not without your diabetes team. People with type 1 diabetes can develop diabetic ketoacidosis without basal insulin. In type 2 diabetes, changes should be planned with your doctor or pharmacist.
Sources
- 1.LANTUS (insulin glargine) injection prescribing information (opens in a new tab) · DailyMed / Sanofi, 2025
- 2.National estimates of insulin-related hypoglycemia and errors leading to emergency department visits and hospitalizations (opens in a new tab) · JAMA Internal Medicine, 2014
- 3.High strength, fixed combination and biosimilar insulin products: minimising the risk of medication error (opens in a new tab) · MHRA Drug Safety Update, 2015
- 4.Insulins (all types): risk of cutaneous amyloidosis at injection site (opens in a new tab) · MHRA Drug Safety Update, 2020
- 5.Insulin glargine: studies of possible cancer link (opens in a new tab) · MHRA Drug Safety Update, 2009