Study S001693

Pharmacokinetics of a Single Dulaglutide Dose in Healthy Chinese Subjects and of Multiple Dulaglutide Doses in Chinese Patients With T2DM

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: NCT01667900
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: DOUBLE
Status: COMPLETED
Enrollment: 58
Start: 2012-08
Primary completion: 2014-06
Lead sponsor: Eli Lilly and Company
Conditions: Diabetes Mellitus, Type 2; Healthy Volunteers
Interventions: DRUG:Dulaglutide; DRUG:Placebo
Results posted: TRUE
Secondary identifiers: OTHER:H9X-EW-GBDL

Registered primary outcomes

Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide [Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose]
Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide [Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose]
Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide [Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose]
Pharmacokinetics: Half-life of Dulaglutide [Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose]

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
R0021744	Pharmacokinetics, Pharmacodynamics, and Safety of Dulaglutide After Single or Multiple Doses in Chinese Healthy Subjects and Patients with T2DM: A Randomized, Placebo-Controlled, Phase I Study. Xu J, Advances in therapy	2022	Randomized trial	PMID 34787823 DOI	cites ClinicalTrials.gov:NCT01667900; registry reference DERIVED:34787823