Abstract | INTRODUCTION: 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.
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Authors | Andreas Brønden, Signe V Naver, Filip K Knop, Mikkel Christensen |
Journal | Expert opinion on drug metabolism & toxicology
(Expert Opin Drug Metab Toxicol)
Vol. 11
Issue 9
Pg. 1493-503
( 2015)
ISSN: 1744-7607 [Electronic] England |
PMID | 26166682
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Glucagon-Like Peptide-1 Receptor
- Hypoglycemic Agents
- rGLP-1 protein
- Glucagon-Like Peptide 1
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Topics |
- Adult
- Clinical Trials, Phase I as Topic
- Clinical Trials, Phase II as Topic
- Clinical Trials, Phase III as Topic
- Diabetes Mellitus, Type 2
(drug therapy)
- Dose-Response Relationship, Drug
- Glucagon-Like Peptide 1
(administration & dosage, analogs & derivatives, pharmacokinetics, pharmacology)
- Glucagon-Like Peptide-1 Receptor
(agonists)
- Humans
- Hypoglycemic Agents
(administration & dosage, pharmacokinetics, pharmacology)
- Weight Loss
(drug effects)
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