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Lower hypoglycemia rates observed with iDegLira combination vs. basal insulins
In adults with type 2 diabetes, treatment with a fixed combination of insulin degludec and liraglutide resulted in lower rates of hypoglycemia compared with insulin degludec or insulin glargine U100, regardless of dosing time or the definition of hypoglycemia used, according to post hoc analyses of two studies.
Using different definitions of hypoglycemia, researchers re-analyzed data from two trials, DUAL I and DUAL V, which compared iDegLira (Xultophy, Novo Nordisk) with basal insulin therapies. In both trials, the original definition of confirmed hypoglycemia was 56 mg/dL or lower; nocturnal hypoglycemia was classified as occurring between 12:01 a.m. and 5:59 a.m.
“Several other definitions of hypoglycemia are described in the literature, however, and have been used across different diabetes clinical trials, and the rates of hypoglycemia reported in a clinical trial will inevitably be affected by the definitions used,” Paul Norwood, MD, FACE, associate professor of medicine at the University of California at San Francisco, and colleagues wrote in the study background. “It is also possible that any differences in outcomes associated with differing dosing times, for example the rate of nocturnal hypoglycemia, could be masked by the overall hypoglycemia advantages reported for iDegLira in these studies. Therefore, the hypoglycemia results were also analyzed by dosing time and by varying the definition of the nocturnal period to better characterize the clinical profile of iDegLira with regard to its relative risks for hypoglycemia.”
Norwood and colleagues analyzed data from 834 insulin-naive patients with type 2 diabetes who were randomly assigned iDegLira (n = 834), insulin degludec alone (Tresiba, Novo Nordisk; n = 414) or liraglutide (Victoza, Novo Nordisk; n = 415) for 26 weeks, as well as 5,557 patients with type 2 diabetes uncontrolled with 20 U to 50 U insulin glargine U100 (Lantus, Sanofi-Aventis) who were randomly assigned iDegLira (n = 278) or up-titrated insulin glargine U100 (n = 279) for 26 weeks. Analyses were carried out according to hypoglycemia definitions that included plasma glucose 56 mg/dL or lower and unable to self-treat, 56 mg/dL or lower with reported symptoms and/or unable to self-treat, or symptomatic episodes confirmed by plasma glucose 70 mg/dL or lower. Further analyses were carried out according to whether both treatments were administered in the morning or evening. Rates of hypoglycemia across definitions were compared with patient data stratified by age, sex and BMI.
The researchers found that hypoglycemia estimated rate ratios by treatment were lower for patients assigned iDegLira vs. insulin degludec or insulin glargine U100 for all definitions of hypoglycemia, including confirmed, symptomatic and American Diabetes Association-documented symptomatic episodes. Patients treated with iDegLira also experienced lower rates of confirmed and nocturnal hypoglycemia vs. insulin glargine U100 whether both treatments were dosed in the morning or evening, according to the researchers. In interaction analyses, researchers found no effect of age, sex or BMI on the estimated treatment rate ratio for iDegLira vs. insulin degludec for either confirmed or ADA-documented symptomatic hypoglycemia (P > .1 for all).
Odds of achieving HbA1c 7% or lower or 6.5% or lower without ADA-documented symptomatic hypoglycemia and without hypoglycemia and weight gain were also greater for iDegLira vs. insulin degludec or insulin glargine U100 (P < .0001 for all). Patients aged at least 65 years experienced a greater reduction in hypoglycemia vs. patients aged 65 years or younger, according to the researchers.
“Therefore, a broad variety of patients with type 2 diabetes might expect to reach their treatment targets with low hypoglycemia rates during treatment with iDegLira,” the researchers wrote. – by Regina Schaffer
Disclosure: Norwood reports receiving research funding from Novo Nordisk and works with AstraZeneca, Eli Lilly, Sanofi and other companies. Please see the full study for the other authors’ relevant financial disclosures.