medwireNews: Research shows that a fixed-dose combination of insulin degludec and liraglutide is as effective as a basal–bolus insulin regimen in insulin-dependent patients with type 2 diabetes, and requires just one daily injection.
In the randomized trial, 252 patients received the combination treatment, at a starting dose of 16 units, titrated up to a maximum of 50 units (the combination contains 0.036 mg of liraglutide per unit of the long-acting insulin degludec).
By the end of the 26-week trial, patients in the combination treatment group were taking an average of 40 units of insulin degludec/liraglutide, whereas the 254 patients who remained on basal–bolus insulin were taking 84 units on average. And they required four to five daily injections, whereas patients taking the combination drug needed only one, which could be administered at whatever time of day they preferred.
At baseline, the patients had uncontrolled blood sugar, despite treatment with insulin glargine plus metformin. Initial average glycated hemoglobin levels were 8.2% in both groups, and during treatment they fell by 1.48% in the insulin degludec/liraglutide group and by 1.46% in the basal–bolus insulin group, meeting the researchers’ criterion for non-inferiority.
But presenter Liana Billings (NorthShore University Health System, Skokie, Illinois, USA) told delegates at the American Diabetes Association scientific sessions that the insulin degludec/liraglutide combination was in some ways superior. Although a similar proportion of patients in each group achieved HbA1c levels below 7.0%, the results differed markedly when adding in other important outcomes.
Weight fell by 0.93 kg in the combination treatment group, compared with a 2.64 kg increase in the basal–bolus insulin group, so the proportions of patients to achieve their HbA1c target without gaining weight were 43.3% and 15.5%, respectively. The corresponding proportions to achieve their HbA1c target without having a severe or blood glucose-confirmed hypoglycemic episode were 57.6% versus 33.5%, and the proportions achieving all three outcomes were 38.2% versus 6.4%.
Adverse events were fairly similar in both groups, except for an increased rate of nasopharyngitis in the insulin-only group and of nausea in the insulin degludec/liraglutide group, although Billings stressed that the prevalence of nausea among these patients at any given point in the trial was never higher than 3%.
An audience member commenting on the trial noted that when basal–bolus insulin is used as a comparator, it is not always managed effectively. In this case it was, reducing patients’ HbA1c levels to an acceptable average, yet a treatment delivered in a single daily injection proved every bit as effective, prompting the delegate to describe the trial as “one of the most robust, most impressive pieces of data I have seen in years.”
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