Albiglutide, a weekly GLP-1 receptor agonist, improves glycemic parameters in Japanese patients with type 2 diabetes over 1 year when added to single oral antidiabetic drugs

Abstract

Objective: To evaluate the safety and efficacy of once weekly albiglutide added to a single oral antidiabetic drug (OAD) in Japanese patients with inadequately controlled type 2 diabetes mellitus (T2DM).

Research design and methods: In this phase 3, 1 year study (NCT01777282), patients (N = 374) received albiglutide 30 mg plus a single OAD (sulfonylurea [n = 120], biguanide [n = 67)], glinide [n = 65], thiazolidinedione [n = 61], or α-glucosidase inhibitor [n = 61]). Albiglutide could be increased to 50 mg after Week 4, based on glycemic criteria. Primary endpoints were the incidence of adverse events (AEs) and hypoglycemia; secondary endpoints were changes from baseline at Week 52 in HbA_1c and fasting plasma glucose (FPG), proportion of patients achieving HbA_1c ≤7.0%, and withdrawals due to hyperglycemia.

Results: On-therapy AEs occurred in 78.6% of patients and serious AEs in 2.1%. Common AEs were nasopharyngitis (32.6%), constipation (7.2%), and diabetic retinopathy (5.3%). No serious AEs occurred more than once or were reported in >1 patient. Hypoglycemia occurred in 6.4% of patients, mostly in the albiglutide + sulfonylurea (14.2%) and the albiglutide + glinide (6.2%) groups. Albiglutide was uptitrated in 53.2% of patients. Mean baseline HbA_1c was 8.1%. Mean decreases from baseline in HbA_1c were observed with the addition of albiglutide to thiazolidinediones (−1.42%), α-glucosidase inhibitors (−1.39%), sulfonylureas (−1.04%), glinides (−0.95%), and biguanides (−0.94%). HbA_1c of <7% in >50% of patients and mean reductions in FPG were achieved in all groups. Mean changes from baseline in body weight ranged from +0.52 kg (albiglutide + thiazolidinedione) to −0.33 kg (albiglutide + biguanide). Limitations of the study included open label treatment that was not randomized.

Conclusions: When combined with a single OAD in Japanese patients with inadequately controlled T2DM, albiglutide led to favorable changes in all glycemic parameters, with minor changes in body weight depending on the background OAD. No new safety concerns were noted.

Keywords:

• Albiglutide
• GLP-1
• Japanese population
• type 2 diabetes mellitus

Transparency

Declaration of funding

This study was funded by GlaxoSmithKline.

Author contributions: All listed authors meet the criteria for authorship set forth by the International Committee for Medical Journal Editors. I.O., H.N., M.C.C., and Y.S. contributed to the concept and design; I.O., T.H.W., L.Y., H.N., M.C.C., M.T., and A.N. contributed to the acquisition, analysis, and/or interpretation of data. All authors commented critically and provided final approval for submission and agreed to be responsible for the content.

Declaration of financial/other relationships

I.O., L.Y., H.N., M.C.C., M.T., and A.N. have disclosed that they are employees of and hold stock in GSK; T.H.W. has disclosed that he is an employee of PAREXEL International and holds stock in GSK. Y.S. has disclosed that he has received consulting and/or speaker fees from Kao, Kyowa Hakko Kirin, Taisho Pharmaceuticals, Becton Dickinson and Company, Novo Nordisk, and MSD; and speakers’ bureau fees from Novo Nordisk, MSD, Takeda Pharmaceutical, Sanofi, Taisho Pharmaceuticals, Toyama Pharmaceutical Association, Eli Lilly and Company, Mitsubishi Tanabe Pharma, Ono Pharmaceuticals, Kowa Pharmaceuticals America Inc., Astellas Pharma, and Boehringer Ingelheim.

CMRO peer reviewer 1 has disclosed that he has been the recipient of research/grant funding from GlaxoSmithKline, Novartis, Novo Nordisk, Takeda, Astra-Zeneca, NIH, sanofi-aventis, Eli Lilly and Daiichi-Sankyo. He has also been a consultant to, and lecturer for, GlaxoSmithKline, Novartis, Takeda, sanofi-aventis, Eli Lilly and Daiichi Sankyo; and is on the speakers’ bureau for Novo Nordisk and sanofi-aventis. CMRO peer reviewer 2 has given talks, attended conferences and participated in trials sponsored by various pharmaceutical companies. CMRO peer reviewer 3 has no relevant financial or other relationships to disclose.

Acknowledgments

Editorial support was provided by Pasquale Iannuzzelli PhD and Elizabeth Rosenberg PhD of AOI Communications LP, with funding provided by GlaxoSmithKline. The authors would also like to thank the patients and physicians who participated in the study.

Previous presentation: A poster was previously presented at the 76th Scientific Sessions of the American Diabetes Association, New Orleans, LA, USA, 10–14 June 2016, entitled Albiglutide, a weekly GLP-1 agonist, improved glycemic parameters in Japanese type 2 diabetes mellitus (T2DM) patients over 1 year when added to single oral antihyperglycemic medications.