Albiglutide for treating type 2 diabetes: an evaluation of pharmacokinetics/pharmacodynamics and clinical efficacy

TY - JOUR

T1 - Albiglutide for treating type 2 diabetes

T2 - an evaluation of pharmacokinetics/pharmacodynamics and clinical efficacy

AU - Brønden, Andreas

AU - Naver, Signe V.

AU - Knop, Filip K.

AU - Christensen, Mikkel

PY - 2015/9/2

Y1 - 2015/9/2

N2 - INTRODUCTION: Albiglutide is a once-weekly, glucagon-like peptide-1 receptor agonist approved during 2014 in both the US and Europe for the treatment of adults with type 2 diabetes. The recommended dose is 30 mg with the possibility of uptitration to 50 mg based on individual glycemic response.AREAS COVERED: Here, we outline the pharmacokinetics, pharmacodynamics and clinical efficacy data originating from the Phase I - III studies carried out to obtain market authorization for albiglutide.EXPERT OPINION: The eight Phase III clinical trials have provided evidence that albiglutide in monotherapy and as an add-on to different background therapies confers placebo-corrected reductions in glycemia with changes in glycated hemoglobin of -0.8 to -1.0%. Albiglutide did not cause significant weight loss compared to placebo, but the adverse events profile was favorable with gastrointestinal adverse events occurring only slightly more with albiglutide than placebo. There is no clinical evidence of an effect of albiglutide on major cardiovascular outcomes.

AB - INTRODUCTION: Albiglutide is a once-weekly, glucagon-like peptide-1 receptor agonist approved during 2014 in both the US and Europe for the treatment of adults with type 2 diabetes. The recommended dose is 30 mg with the possibility of uptitration to 50 mg based on individual glycemic response.AREAS COVERED: Here, we outline the pharmacokinetics, pharmacodynamics and clinical efficacy data originating from the Phase I - III studies carried out to obtain market authorization for albiglutide.EXPERT OPINION: The eight Phase III clinical trials have provided evidence that albiglutide in monotherapy and as an add-on to different background therapies confers placebo-corrected reductions in glycemia with changes in glycated hemoglobin of -0.8 to -1.0%. Albiglutide did not cause significant weight loss compared to placebo, but the adverse events profile was favorable with gastrointestinal adverse events occurring only slightly more with albiglutide than placebo. There is no clinical evidence of an effect of albiglutide on major cardiovascular outcomes.

KW - Adult

KW - Clinical Trials, Phase I as Topic

KW - Clinical Trials, Phase II as Topic

KW - Clinical Trials, Phase III as Topic

KW - Diabetes Mellitus, Type 2

KW - Dose-Response Relationship, Drug

KW - Glucagon-Like Peptide 1

KW - Glucagon-Like Peptide-1 Receptor

KW - Humans

KW - Hypoglycemic Agents

KW - Weight Loss

U2 - 10.1517/17425255.2015.1068288

DO - 10.1517/17425255.2015.1068288

M3 - Journal article

C2 - 26166682

SN - 1742-5255

VL - 11

SP - 1493

EP - 1503

JO - Expert Opinion on Drug Metabolism and Toxicology

JF - Expert Opinion on Drug Metabolism and Toxicology

IS - 9

ER -