Study S000822

A Randomized, Double-blind, Single-dose, Crossover Study to Compare Two Albiglutide Drug Products for Bioequivalence in Healthy Adult Subjects

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT02660736
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: DOUBLE
Status: COMPLETED
Enrollment: 59
Start: 2016-02
Primary completion: 2016-08
Lead sponsor: GlaxoSmithKline
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Albiglutide Liquid Auto-injector; DRUG:Albiglutide Lyophilized DCC Pen Injector; DRUG:Placebo Liquid Auto-injector; DRUG:Placebo Lyophilized DCC Pen injector
Results posted: FALSE

Registered primary outcomes

Area under the plasma concentration-time curve (AUC) from 0 to the last measurable concentration (AUC 0-t) for albiglutide in session 1 and 2 [Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2]
AUC from 0 to infinity (AUC [0-inf]) for albiglutide in session 1 and 2 [Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2]
Peak plasma concentration (Cmax) for albiglutide in session 1 and 2 [Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0023629	A Randomized, Double-Blind, Single-Dose, Crossover Study to Demonstrate the Bioequivalence of 2 Formulations of Albiglutide in Healthy Adult Participants. Shaddinger BC, Clinical pharmacology in drug development	2019	Randomized trial	PMID 30063297 DOI	cites ClinicalTrials.gov:NCT02660736; registry reference DERIVED:30063297