| Safety, tolerability, pharmacokinetics and pharmacodynamics of albiglutide, a long-acting GLP-1-receptor agonist, in Japanese subjects with type 2 diabetes mellitus. | |
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MedLine Citation:
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PMID: 19863477 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: To investigate safety, pharmacokinetics and pharmacodynamics of albiglutide in Japanese subjects with type 2 diabetes mellitus. RESEARCH DESIGN AND METHODS: This randomized, single-blind, placebo-controlled study examined four doses/dose schedules of subcutaneously (sc) administered albiglutide: 15 mg weekly, 30 mg weekly, 50 mg biweekly, and 100 mg monthly (cohorts A-D, respectively) in 40 subjects (mean age 54.5 years, mean range of glycosylated hemoglobin [HbA(1c)] 7.1-8.3%), over a 4-week treatment period. MAIN OUTCOME MEASURES: Safety parameters, including adverse events, clinical laboratory tests, vital signs, and 12-lead electrocardiogram; plasma concentrations of albiglutide; and pharmacodynamic parameters, including change from baseline and weighted mean AUC(0-4) in plasma glucose, glucagon, insulin, and C-peptide levels. CLINICAL TRIAL REGISTRATION: NCT00530309. RESULTS: At day 29, mean changes from baseline (vs. placebo) in fasting plasma glucose (FPG) were: cohort A, -1.92 mmol/L; B, -1.98 mmol/L; C, -1.74 mmol/L; D, -0.73 mmol/L; changes in weighted mean glucose AUC(0-4) were: cohort A, -2.86 mmol/L; B, -3.58 mmol/L; C, -2.51 mmol/L; D, -1.44 mmol/L (for FPG and AUC(0-4), all p < or = 0.002 except 100 mg sc monthly, p = NS); changes from baseline HbA(1c) were: cohort A, -0.58%; B, -0.57%; C, -0.63%; and D, -0.51% (all p < 0.03). Albiglutide sc had a median half-life of 5.3 days, plasma apparent systemic clearance of 68.7 mL/h, and apparent volume of distribution of 12.6 L. Incidence of adverse events was low and comparable to sc placebo in all albiglutide treatment arms except 100 mg sc monthly, where gastrointestinal (GI) adverse events were most common. Limitations of this study include the small sample size, short treatment duration, and enrollment of predominantly male subjects. CONCLUSIONS: Weekly and biweekly albiglutide improved glycemic control and were well-tolerated in Japanese subjects with type 2 diabetes mellitus. |
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Authors:
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Yutaka Seino; Hiromu Nakajima; Hajime Miyahara; Takashi Kurita; Mark A Bush; Fred Yang; Murray W Stewart |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Current medical research and opinion Volume: 25 ISSN: 1473-4877 ISO Abbreviation: Curr Med Res Opin Publication Date: 2009 Dec |
Date Detail:
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Created Date: 2009-11-17 Completed Date: 2010-02-22 Revised Date: 2013-03-19 |
Medline Journal Info:
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Nlm Unique ID: 0351014 Medline TA: Curr Med Res Opin Country: England |
Other Details:
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Languages: eng Pagination: 3049-57 Citation Subset: IM |
Affiliation:
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Kansai Electric Power Hospital, Osaka, Japan. seino.yutaka@e2.kepco.co.jp |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00530309 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Algorithms Asian Continental Ancestry Group Delayed-Action Preparations / adverse effects, pharmacokinetics, therapeutic use Diabetes Mellitus, Type 2 / drug therapy*, metabolism Dose-Response Relationship, Drug Drug Administration Schedule Female Glucagon-Like Peptide 1 / administration & dosage, adverse effects, analogs & derivatives*, pharmacokinetics, therapeutic use Humans Hypoglycemic Agents / adverse effects, pharmacokinetics, therapeutic use Male Middle Aged Placebos Receptors, Glucagon / agonists Single-Blind Method |
| Chemical | |
Reg. No./Substance:
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0/Delayed-Action Preparations; 0/Hypoglycemic Agents; 0/Placebos; 0/Receptors, Glucagon; 0/albiglutide; 0/glucagon-like peptide-1 receptor; 89750-14-1/Glucagon-Like Peptide 1 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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