Patients with T2D receiving albiglutide in HARMONY studies were less likely to require rescue therapy.
A large-scale, international efficacy study on the use of albiglutide (Tanzeum/GlaxoSmithKline) for glycemic control in type 2 diabetes (T2D) finds that patients receiving the drug as part of their treatment were less likely to require rescue therapy, and after 3 years of treatment saw “clinically significant reductions in hyperglycemia,” according to the international research team.
Philip D. Home, PhD, MRCP, DM, MBBCh, and colleagues from the United Kingdom, United States, Sweden, and Germany, examined data from 5 HARMONY studies to determine efficacy, durability, tolerance, and safety after 3 years of treatment. Their analysis determined that albiglutide, an injectible glucagen-like peptide-1 (GLP-1) receptor agonist, provided durable glycemic control, and that most study patients remained rescue-free for 2 to 3 years.
The HARMONY trials took place in 11 countries and involved more than 5000 patients. The first 2 trials—both 52-week, randomized, double-blind, placebo-controlled studies—determined that albiglutide as an add-on therapy (HARMONY 1) or a standalone therapy (HARMONY 2) was effective in lowering hemoglobin A1c (HbA1c), signaling lower average glycemic levels and greater diabetic control. More than 60% of participants taking albiglutide achieved HbA1c of <7.0% after treatment with an average of -0.70% reduction in baseline HbA1c levels.
HARMONY 3, a 104-week study, tested albiglutide as an add-on to metformin, and determined that the addition of the drug allowed patients to achieve a significant reduction in baseline HbA1c (an average of -0.78%). HARMONY 4, a 52-week, randomized, open-label study, tested the use of albiglutide plus metformin against basal insulin, determining that although patients on both medications achieved a similar reduction in baseline HbA1c, patients taking albiglutide plus metformin saw significant weight loss during the 52-week trial, averaging -1.1 kg in comparison with patients using basal insulin treatments, who saw an average weight increase of 1.6 kg.
HARMONY 5 compared albiglutide as an add-on therapy for patients using metformin in comparison with patients using other comparative add-on therapies with metformin, and found that although the use of albiglutide was equivalent to other medications in controlling diabetes, patients experienced significantly more weight loss with the use of albiglutide. Patients receiving albiglutide averaged a loss of 0.7 kb in 26 weeks in comparison to a gain of 0.8 kb with use of insulin lispro.
Data from the 5 HARMONY trials included 3132 people randomized in the 5 studies with 1409 participants receiving albiglutide over 3 years of treatment. The data showed that significantly greater proportions of participants allocated to albiglutide (55% to 71%) were rescue-free compared with both placebo (35% to 51%) and patients receiving sitagliptin (62%), and that patients receiving albiglutide saw results similar to other oral agents, such as glimepiride (66%), pioglitazone (59%), and insulin glargine (59%).
According to the researchers, among cases with observed data at the 3-year time point, treatment with albiglutide also resulted in HbA1c of <7.0% in both the rescue-free and all-participants groups in 33% (HARMONY 1) to 60% (HARMONY 5) of participants. Homes and colleagues found that a majority of participants (average 63.4%) randomized to albiglutide did not require rescue therapy within 2 years, and indeed in some of the studies did not require rescue within the 3-year study duration; median time to hyperglycemic rescue was >118 weeks in HARMONY 2, and >107 and >138 weeks in HARMONY 4 and 5, respectively.
The authors argue that one of the burdens of T2D is polypharmacy, and that the use of multiple, sometimes shifting medications, to address the disease and associated morbidities while maintaining glycemic control is important. If albiglutide, Home and colleagues argue, can provide stable glycemic control for patients with T2D, circumventing the need for additional rescue medications, then some of the polypharmacy burden can be lifted.
They also point out that it is difficult for patients with T2D to maintain their glycemic control over time; Homes wrote that “deteriorating glycemic control mandates stepped addition and changes in therapy with injectable agents--which in the past mainly meant insulin therapy--is often required.” The colleagues believe that use of albiglutide can offer assistance with durable glycemic control, and that the use of albiglutide as a stand-alone or add-on treatment for T2D appears to provide opportunities for clinicians to optimize management of glycemia for long-term patient benefit.
The article can be found in the September 2017 issue of Diabetes Research and Clinical Practice.