Lantus Regret, Stopping, and Restarting: What Real Patients and Clinicians Say

At a glance

  • Drug / insulin glargine (Lantus), once-daily long-acting basal insulin injected subcutaneously [1]
  • Label on regimen changes / strength, manufacturer, type, injection site or method can shift control toward hypoglycemia or hyperglycemia [1]
  • Most common adverse reaction / hypoglycemia, which can be life-threatening [1]
  • Severe hypoglycemia, type 1 adults / 10.6% on Lantus vs 15.0% on NPH over 28 weeks [1]
  • Night-time lows, type 2 adults / 12% on insulin glargine vs 24% on NPH over 52 weeks [2]
  • Starting dose, type 2 not on insulin / 0.2 units/kg or up to 10 units once daily [1]

What the Lantus label says about changing a regimen

The label states that changes to an insulin regimen, including insulin strength, manufacturer, type, injection site or method of administration, may affect glycemic control and predispose to hypoglycemia or hyperglycemia [1]. It says these changes should be made under close medical supervision with increased frequency of blood glucose monitoring [1]. The label also says that in type 1 diabetes Lantus must be used with a short-acting mealtime insulin, and that it is not recommended for treating diabetic ketoacidosis [1].

Low blood sugar: the numbers

Severe symptomatic hypoglycemia, meaning an event requiring another person's help, occurred in 10.6% of adults with type 1 diabetes on Lantus versus 15.0% on NPH over 28 weeks, and in 1.7% versus 1.1% of adults with type 2 diabetes over 52 weeks alongside oral agents [1]. In a 52-week trial of 570 adults with type 2 diabetes taking oral agents, at least one night-time low was reported by 12% of those on insulin glargine versus 24% on NPH insulin (P=0.002) [2].

Weight gain

Weight gain is listed among the adverse reactions commonly associated with insulin glargine products, attributed in the label to the anabolic effects of insulin and the decrease in glucose lost in urine [1]. In ORIGIN, which enrolled 12,537 people with cardiovascular risk factors plus impaired fasting glucose, impaired glucose tolerance or type 2 diabetes, weight rose 1.6 kg on insulin glargine versus a 0.5 kg fall on standard care over a median of 6.2 years [3].

Doses used when insulin glargine is started

For type 2 diabetes not currently treated with insulin, the label lists a starting dose of 0.2 units/kg or up to 10 units once daily [1]. For type 1 diabetes it lists approximately one-third of the total daily insulin requirement as basal insulin, with short-acting premeal insulin covering the rest [1]. The label says to monitor glucose closely when switching to Lantus and during the initial weeks afterward [1]. It says Lantus is injected subcutaneously once daily at the same time each day, is not diluted or mixed with other insulin, and is not given intravenously or by insulin pump [1].

Brand and strength switches

Semglee (approved July 2021) and Rezvoglar (December 2021) are FDA-approved biosimilars of Lantus, and FDA lists Semglee as the first interchangeable biosimilar insulin [5]. A change of manufacturer is still listed as a regimen change in the Lantus label [1]. Toujeo is insulin glargine at 300 units/mL, three times the concentration of Lantus at 100 units/mL [6][7]. For a switch from once-daily Toujeo, the Lantus label starts Lantus at 80% of the Toujeo dose [1].

Frequently asked questions

What does the Lantus label say about changing or stopping?
The label addresses regimen changes such as insulin strength, manufacturer, type, injection site or method of administration, which it says may shift control toward hypoglycemia or hyperglycemia [1]. It also states that in type 1 diabetes Lantus must be used with a short-acting mealtime insulin [1].
Does Lantus cause weight gain?
Weight gain is listed among the adverse reactions commonly associated with insulin glargine products, attributed to insulin's anabolic effects and the decrease in glucose lost in urine [1]. In ORIGIN, weight rose 1.6 kg on insulin glargine versus a 0.5 kg fall on standard care over a median of 6.2 years [3].
What starting dose does the Lantus label list?
For adults with type 2 diabetes not currently treated with insulin, 0.2 units/kg or up to 10 units once daily [1]. For type 1 diabetes, approximately one-third of the total daily insulin requirement as basal insulin, with short-acting premeal insulin covering the remainder [1].
Is switching to a biosimilar the same as restarting?
Semglee and Rezvoglar are FDA-approved biosimilars of Lantus, and FDA lists Semglee as the first interchangeable biosimilar insulin [5]. The Lantus label lists a change of manufacturer among the regimen changes that may affect glycemic control [1].

References

  1. U.S. National Library of Medicine, DailyMed. LANTUS SOLOSTAR (insulin glargine) prescribing information. LANTUS SOLOSTAR (insulin glargine) label
  2. Massi Benedetti M, Humburg E, Dressler A, Ziemen M. A one-year, randomised, multicentre trial comparing insulin glargine with NPH insulin in combination with oral agents in patients with type 2 diabetes. Horm Metab Res. 2003;35(3):189-96. A one-year, randomised, multicentre trial comparing insulin glargine with NPH insulin in combination with oral agents in patients with type 2 diabetes
  3. ORIGIN Trial Investigators, Gerstein HC, Bosch J, Dagenais GR, Díaz R, Jung H, et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med. 2012;367(4):319-28. Basal insulin and cardiovascular and other outcomes in dysglycemia
  4. Rodbard HW, Lingvay I, Reed J, de la Rosa R, Rose L, Sugimoto D, et al. Semaglutide Added to Basal Insulin in Type 2 Diabetes (SUSTAIN 5): A Randomized, Controlled Trial. J Clin Endocrinol Metab. 2018;103(6):2291-2301. Semaglutide Added to Basal Insulin in Type 2 Diabetes (SUSTAIN 5): A Randomized, Controlled Trial
  5. Biosimilar Product Information | FDA. Biosimilar Product Information | FDA
  6. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  7. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
Evidence overview for reviews insulin glargine: Lantus Regret, Stopping, and Restarting: What Real Patients and Clinicians Say