High-Strength Insulin Glargine Reduces Hypoglycemic Events in T2D

ORLANDO -- Patients with type 2 diabetes who switched to insulin glargine 300 U/mL (Gla-300, Toujeo) from basal insulin showed less risk for hypoglycemic events versus other basal insulin analogs, according to the DELIVER 2 study.

The retrospective, observational study found significantly fewer events of hypoglycemia among patients who switched to Gla-300 compared to patients who switched to other modified insulin proteins (incidence: 15.1% versus 19.9%, respectively; P=0.03), according to Fang Liz Zhou, MD, of drugmaker Sanofi, and colleagues.

Gla-300 is a newer, more concentrated form of insulin glargine, which is otherwise the same protein as in Sanofi's 100 U/mL Lantus product.

Presented as a late-breaking abstract at ENDO 2017, the study also reported patients who switched to Gla-300 had a lower hypoglycemia event rate after six months of treatment, in a model adjusted for baseline hypoglycemia (difference between least squares means: 2.67 events/100 patient-months, P=0.001).

Zhou's group also reported these significant improvements in hypoglycemia incidence and hospitalization could be seen three-months following the treatment switch.

Conducted in a real-world clinical setting, DELIVER 2 also found a 48% drop in inpatient or emergency department visits related to hypoglycemia among those who switched to Gla-300 (event rate: 3.82 of patients versus 1.97, respectively; P<0.01).

These results build upon previous findings from the randomized controlled EDITION trials, and the observational DELIVER 1 trial, which was presented at the 2016 American Diabetes Association's meeting. These prior trials established Gla-300 was as effective for glycemic control in patients with type 2 diabetes, when compared to insulin glargine 100 U/mL, with fewer reports of hypoglycemia.

"Sanofi is committed to going beyond traditional models to conduct further studies to assess Toujeo, combining the broad populations, and type of interaction between healthcare professionals and patients seen in routine care with the rigorous methodology of clinical trials. The randomized Real Life Study program will provide further evidence that directly reflects Toujeo's performance in standard clinical practice," stated Riccardo Perfetti, Head of Global Diabetes Medical Team, ‎Sanofi, in a press release.

DELIVER 2 included 1,894 patients, whose electronic medical records were drawn from the Predictive Health Intelligence Environment database, which represented 26 integrated healthcare networks. Participants who switched to Gla-300 (n=947) were matched 1:1 to those switching other basal insulins, including insulin glargine 100 Units/mL, insulin detemir or insulin degludec. All patients had been using basal insulin prior to intervention.

Six months after switching, both groups reported significant drops in HbA1c levels from baseline (8.89% to 8.42% for Gla-300; 8.92% to 8.50% for other basal insulins; P<0.001 for both), without significant between-group differences (P=0.44). Both groups were also more likely to reach target A1c goals six months after switching (<7.0% goal: 6.9% Gla-300 versus 18.7% other basal insulins, respectively; P=0.35)(<8.0% goal: 45.0% versus 42.0%; P=0.31).

Gla-300 is not currently approved for use in children or to treat diabetic ketoacidosis.

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