Albiglutide efficacy and safety in the Latino/Hispanic subpopulation for the integrated phase III program

ABSTRACT

Objective: to evaluate the efficacy and safety of albiglutide compared with placebo and active comparators from an integrated trial subpopulation of Latino/Hispanic patients whose type 2 diabetes mellitus (T2DM) was inadequately controlled on their current regimen of diet and exercise, with or without oral antidiabetic drugs (OADs) and/or insulin.

Methods: Latino/Hispanic patient subpopulations (N = 1204) across 7 phase III albiglutide studies (N = 4400) were evaluated post-hoc for efficacy and safety. Comparators were placebo, sulfonylureas, insulin, thiazolidinediones, and dipeptidyl peptidase-4 inhibitors. Glycatedhemoglobin (HbA_1c) change from baseline to the time of the primary endpoint assessment (from 26 to 104 weeks) was evaluated in patients on diet and exercise and/or OADs, with or without insulin. Patients were allowed to continue in the study if hyperglycemic rescue was required, according to a prespecified algorithm and at the discretion of the investigator.

Results: At baseline in the Latino/Hispanic subpopulation, the mean HbA_1c was 8.3%, mean age was 53 years, mean body mass index was 32 kg/m², and mean duration of T2DM was 8.0 years. The primary endpoint of mean HbA_1c difference (albiglutide – placebo) was −0.94% for the Latino/Hispanic subpopulation and −0.86% (p < 0.001) for the overall phase III population. Changes in fasting plasma glucose mirrored those of HbA_1c. Weight loss with albiglutide was numerically greater than with OADs and insulin in both populations, but it was smaller than with liraglutide. Within the Latino/Hispanic subpopulation, more injection-site reactions were reported with albiglutide vs all comparators, while gastrointestinal and hypoglycemic adverse events were comparable between the two groups, and the latter was uncommon when used without insulin and/or a sulfonylurea.

Conclusions: In the Latino/Hispanic population, albiglutide resulted in effective lowering of glucose and modest weight loss, and it was generally well tolerated.

KEYWORDS:

• Albiglutide
• glucagon-like peptide-1 receptor
• glucagon-like peptide-1 receptor agonist
• Latino/Hispanic Americans
• type 2 diabetes

Acknowledgments

All listed authors meet the criteria for authorship set forth by the International Committee for Medical Journal Editors. Under the authors’ guidance, technical and medical writing support was provided by Gautam Bijur of AOIC, LLC. Editorial support (assembling tables and figures, collating author comments, copyediting, fact checking, and referencing) and graphic services were provided by AOIC, LLC, and were funded by GSK.

Declaration of interest

JA Davidson has no affiliation with GSK, owns no stock, is not a consultant, and does not belong to an advisory board. A Jones-Leone, A. Nino, and S Forero-Schwanhaeuser are employees of and hold stock in GlaxoSmithKline (GSK). TH Wilson is an employee of PAREXEL International and a former employee of and stockholder in GSK. RR Reinhardt is a former employee of and stockholder in GSK. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Clinicaltrials.gov identifiers

Title: Safety and Efficacy of Albiglutide in Type 2 Diabetes; NCT00849056

URL: https://clinicaltrials.gov/ct2/show/NCT00849056

Title: Safety and Efficacy Study of Albiglutide in Type 2 Diabetes; NCT00849017

URL: https://clinicaltrials.gov/ct2/show/NCT00849017

Title: Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes; NCT00838903

URL: https://clinicaltrials.gov/ct2/show/NCT00838903

Title: A Study to Determine the Safety and Efficacy of Albiglutide in Patients With Type 2 Diabetes; NCT00838916

URL: https://clinicaltrials.gov/ct2/show/NCT00838916

Title: A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes; NCT00839527

URL: https://clinicaltrials.gov/ct2/show/NCT00839527

Title: A Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine; NCT00976391

URL: https://clinicaltrials.gov/ct2/show/NCT00976391

Title: A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide; NCT01128894

URL: https://clinicaltrials.gov/ct2/show/NCT01128894

Title: A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment; NCT01098539

URL: https://clinicaltrials.gov/ct2/show/NCT01098539

Supplemental data

Supplemental data for this article can be accessed here.

Additional information

Funding

Funding for this analysis of the HARMONY trials (NCT00849056; NCT00849017; NCT00838903; NCT00838916; NCT00839527; NCT00976391; NCT01128894; NCT01098539 available from www.clinicaltrials.gov) was provided by GlaxoSmithKline (GSK).