Clinical Pharmacokinetics of Dulaglutide in Patients with Type 2 Diabetes: Analyses of Data from Clinical Trials

Background and Objective Dulaglutide is a long-acting glucagon-like peptide-1 receptor agonist administered as once-weekly subcutaneous injections for the treatment of type 2 diabetes (T2D). The clinical pharmacokinetics of dulaglutide were characterized in patients with T2D and healthy subjects. Me...

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Bibliographic Details
Published in:Clinical pharmacokinetics 2016-05, Vol.55 (5), p.625-634
Main Authors: Geiser, Jeanne S., Heathman, Michael A., Cui, Xuewei, Martin, Jennifer, Loghin, Corina, Chien, Jenny Y., de la Peña, Amparo
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Diabetes Mellitus, Type 2 - metabolism
Drug Administration Routes
Female
Glucagon-Like Peptides - administration & dosage
Glucagon-Like Peptides - analogs & derivatives
Glucagon-Like Peptides - blood
Glucagon-Like Peptides - pharmacokinetics
Humans
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - blood
Hypoglycemic Agents - pharmacokinetics
Immunoglobulin Fc Fragments - administration & dosage
Immunoglobulin Fc Fragments - blood
Internal Medicine
Male
Medicine
Medicine & Public Health
Middle Aged
Original Research Article
Pharmacology/Toxicology
Pharmacotherapy
Recombinant Fusion Proteins - administration & dosage
Recombinant Fusion Proteins - blood
Recombinant Fusion Proteins - pharmacokinetics
Young Adult
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Summary:Background and Objective Dulaglutide is a long-acting glucagon-like peptide-1 receptor agonist administered as once-weekly subcutaneous injections for the treatment of type 2 diabetes (T2D). The clinical pharmacokinetics of dulaglutide were characterized in patients with T2D and healthy subjects. Methods The pharmacokinetics of dulaglutide were assessed throughout clinical development, including conventional pharmacokinetic analysis in clinical pharmacology studies and population pharmacokinetic analyses of data from combined phase 2 and phase 3 studies in patients with T2D. The effects of potential covariates on dulaglutide population pharmacokinetics were evaluated using nonlinear mixed-effects models. Results Dulaglutide gradually reached the maximum concentration in 48 h and had a terminal elimination half-life of 5 days. Steady state was achieved between the second and fourth doses. The accumulation ratio was 1.56 for the 1.5 mg dose. Intra-individual variability estimates for the area under the plasma concentration–time curve and the maximum concentration were both
ISSN:0312-5963
1179-1926
DOI:10.1007/s40262-015-0338-3