Pharmacokinetics, Safety and Tolerability of Once-Weekly Subcutaneous Semaglutide in Healthy Chinese Subjects: A Double-Blind, Phase 1, Randomized Controlled Trial.
Introduction: Once-weekly (OW) subcutaneous (s.c.) semaglutide is an injectable glucagon-like peptide-1 (GLP-1) analogue approved for the treatment of type 2 diabetes. This trial was designed to assess the pharmacokinetics, safety and tolerability of OW s.c. semaglutide in healthy Chinese subjects.M...
| Publicado en: | Advances in Therapy Vol. 38; no. 1; pp. 550 - 562 |
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| Autores principales: | , , , , , |
| Formato: | clinical trial research randomized controlled trial Journal Article |
| Publicado: |
Springer Nature
2021
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=148447591&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 148447591 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 0741238X 1XDX jtl: Advances in Therapy issn: 0741238X maglogo: N pubinfo: dt: 2021 vid: 38 iid: 1 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 148447591 146864766 148447591 NLM33159658 148447591 10.1007/s12325-020-01548-y NLM33159658 148447591 ppf: 550 ppct: 12 formats: tig: atl: Pharmacokinetics, Safety and Tolerability of Once-Weekly Subcutaneous Semaglutide in Healthy Chinese Subjects: A Double-Blind, Phase 1, Randomized Controlled Trial. aug: au: Shi, Aixin Xie, Panpan Nielsen, Lasse Lykke Skjøth, Trine Vang He, Xuemei Haugaard, Sine Pfeiffer affil: Clinical Trial Center, Beijing Hospital, National Center of Gerontology sug: subj: Diabetes Mellitus, Type 2 Double-Blind Studies China Hypoglycemic Agents Adverse Effects Research Subjects Human Glucagon-Like Peptides Adverse Effects Clinical Trials Comparative Studies Multicenter Studies Randomized Controlled Trials Evaluation Research Validation Studies Scales ab: Introduction: Once-weekly (OW) subcutaneous (s.c.) semaglutide is an injectable glucagon-like peptide-1 (GLP-1) analogue approved for the treatment of type 2 diabetes. This trial was designed to assess the pharmacokinetics, safety and tolerability of OW s.c. semaglutide in healthy Chinese subjects.Methods: In this single-centre, randomised, double-blind, placebo-controlled trial, 36 healthy subjects were randomised to OW s.c. semaglutide 0.5 mg (n = 12), 1.0 mg (n = 12), or placebo (n = 12). Treatment (semaglutide or placebo) was blinded for the subjects, investigators and sponsor. The primary endpoint was steady-state semaglutide exposure, defined as the area under the curve over a dosing interval at steady state (AUC0-168 h,SS).Results: In total, 34 subjects completed the trial. The steady-state exposure of semaglutide was higher for subjects treated with 1.0 mg semaglutide (AUC0-168 h,ss: 7961 nmol h/l and Cmax,ss: 55.9 nmol/l) compared to 0.5 mg semaglutide (AUC0-168 h,ss: 4000 nmol h/l and Cmax,ss: 28.8 nmol/l). The total exposure of semaglutide increased in a dose-proportional manner in healthy Chinese subjects; the treatment ratio (1.0 mg/0.5 mg) [95% confidence interval] for AUC0-168 h,SS was 1.99 [1.78; 2.23]. Treatment with OW s.c. semaglutide was well tolerated in healthy Chinese subjects. As expected for the GLP-1 receptor agonist class, the most common adverse events were gastrointestinal, and no new safety signals were identified.Conclusion: The pharmacokinetics, safety and tolerability of OW s.c. semaglutide in healthy Chinese subjects were consistent with previous clinical pharmacology trials of OW s.c. semaglutide in other populations. The results suggest that no dose adjustment is necessary for semaglutide in Chinese patients with T2D.Trial Registration: ClinicalTrials.gov, identifier NCT03288740. pubtype: Academic Journal doctype: clinical trial research randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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