The analysis comes a few weeks after FDA approved a label change that reflects a study showing insulin degludec was associated with a 40% drop in hypoglycemia.
A meta-analysis has been published which finds insulin degludec, sold by Novo Nordisk as Tresiba, has a better safety and efficacy profile than insulin glargine, following initial release of the findings in February.
The results, appearing in the May issue of Acta Diabetologica, come less than a month after FDA updated the label for insulin degludec to reflect results from last summer’s DEVOTE study, which showed the ultra—long acting basal insulin offered the same level of cardiovascular safety as insulin glargine, but was associated with a 40% reduction in severe hypoglycemia.
In the new meta-analysis, researchers pooled data from 18 trials involving 16,791 patients through July 5, 2017. Trials compared the 2 forms of insulin in patients with type 1 (T1D) and type 2 diabetes (T2D) with at least 16 weeks follow-up.
Insulin degludec was associated with a statistically significant reduction in risk for all confirmed hypoglycemia (estimated rate ratio [ERR], 0.81; 95% confidence interval [CI], 0.72-0.92; P = .001), in nocturnal confirmed hypoglycemia, (ERR, 0.71; 95% CI, 0.63-0.80; P <.001), and in the maintenance treatment period, (ERR, 0.65; 95% CI, 0.59-0.71; P <.001).
The differences were especially pronounced at night, during the maintenance periods, and among T2D patients compared with T1D patients. Insulin degludec also produced reductions in severe hypoglycemia in T2D (ERR, 0.65; 95% CI, 0.052-0.89; P = .005), but not among patients with T1D. Glycated hemoglobin (A1C) was slightly higher in the group using insulin degludec, but the researchers reported it was not clinically significant (estimated treatment difference was 0.03; 95% CI, 0.00-0.06; P = .06). Fasting plasma glucose was lower among the insulin degludec group.
Findings in the meta-analysis and FDA’s action come as several diabetes advocacy and research organizations have called on regulators to rely on measures other than A1C when evaluating the efficacy of new diabetes drugs and devices. Leaders from JDRF and the diaTribe Foundation, among others, have been active in the “Beyond A1C” movement, calling on payers to cover treatments and tools that help people with diabetes eat, exercise, and sleep safely through the night.
In an interview with The American Journal of Managed Care®, Mark Warren, MD, described how nocturnal hypoglycemia is a particularly big problem that often goes unrecognized, especially in T2D patients. “If someone comes to the emergency department with severe hypoglycemia, they’re going to be coded for that,” he said, However, “In the practice, we almost never code for hypoglycemia unless they’re coming in comatose or requiring the assistance of someone else in the waiting room. But we always ask about it—we simply don’t code for it. We just call it uncontrolled diabetes.”
At the time of the FDA label update, Todd Hobbs, MD, chief medical officer for Novo Nordisk, said the change would be helpful to clinicians in practice. “Cardiovascular disease and severe hypoglycemia are two of the most profound concerns for people living with diabetes,” he said.
Zhang WW, Zhang XL, Xu B, Kang LN. Comparative safety and efficacy of insulin degludec with insulin glargine in type 2 and type 1 diabetes: a meta-analysis of randomized controlled trials. Acta Diabetol. 2018;55(5):429-441. doi: 10.1007/s00592-018-1107-1.