Weekly Albiglutide Found Equal to Thrice-Daily Insulin for Treatment-Refractory Type 2 Diabetes

A newly reported year-long study found that blood glucose was controlled as well with weekly injections of albiglutide (Tanzeum, GlaxoSmithKline) as with 3-times daily prandial insulin lispro (Humalog, Lilly) when each was used as an adjunct in treatment refractory type 2 diabetes (T2D).

The latest results from the HARMONY 6 Study Group, reported after 52 weeks of protocol treatment and 8 weeks of follow-up, extends their previously reported findings at 26 weeks that weekly administration of the glucagon-like peptide-1 (GLP-1) receptor agonist albiglutide sustains glycemic-lowering comparable to 3-times daily administration of insulin lispro. In addition, albiglutide was associated with reduced body weight from baseline while the insulin lispro group had gained weight by year end.

“While glucose lowering is the main target of [type 2 diabetes mellitus] T2DM treatment, many factors influence treatment decision,” Lawrence Leiter, MD (pictured), Departments of Medicine and Nutritiounal Sciences, University of Toronto, Canada, and lead author on the study, remarked. “One consideration is the potential for increased patient adherence due to a simpler regimen.”

The HARMONY 6 trial identified patients with treatment refractory T2D, who were then stabilized on a basal insulin regimen with insulin glargine (Lantus, Sanofi-Aventis) with or without an oral antidiabetic agent as taken pre-study or required after baseline. The patients were randomized to 1 of 2 adjunctive treatment arms for 52 weeks, with 121 patients adding weekly albiglutide and 141 patients adding 3-times-daily insulin lispro.

Albiglutide could be titrated from 30 mg to 50 mg weekly after week 8, and the insulin combination could be titrated every 2 days over 8 weeks to achieve glycemic targets. Oral antidiabetic agents, other than another GLP-1 receptor agonist, were maintained or added as required. The mean daily doses of insulin glargine at baseline and week 52, respectively, were 47.0 IU and 55.3 IU in the albiglutide group, and 43.3 IU and 53.0 IU in the insulin lispro group. The mean daily doses of insulin lispro were 15.5 IU at baseline, 30.6 IU at week 26, and 33.6 IU at week 52.

Leiter and his colleagues reported that the glycemic-lowering effect of albiglutide was comparable to that of insulin lispro and sustained through week 52, with significant reduction from baseline in hemoglobin A1c and fasting plasma glucose. The treatment arm groups diverged on body weight measures, however, with the albiglutide group having a mean 0.96-kg reduction at week 52 while the insulin lispro had a mean 1.66-kg increase.

Albiglutide was associated with more treatment-related adverse events, and adverse events leading to discontinuation. Injection site reactions were more common with albiglutide, as were gastrointestinal complaints, although the latter principally occurred during the first 26 weeks of treatment with both agents. A greater number of patients receiving albiglutide required hyperglycema rescue, while symptomatic hypoglycemic episodes were more common with insulin lispro.

The report of the HARMONY 6 trial after 52 weeks of treatment is in press in the Journal of Diabetes and Its Complications.

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