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Clinical Trial Details

Trial ID: L5351
Source ID: NCT01667900
Associated Drug: Dulaglutide
Title: A Study of Dulaglutide in Chinese Participants
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01667900/results
Conditions: Diabetes Mellitus, Type 2|Healthy Volunteers
Interventions: DRUG: Dulaglutide|DRUG: Placebo
Outcome Measures: Primary: Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide, Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B., Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose|Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide, Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B., 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, Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B., Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose|Pharmacokinetics: Half-life of Dulaglutide, Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B., Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose | Secondary: Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]), Pharmacodynamic parameters were assessed at baseline and on Days 3, 24, and 29 in Part B., Baseline and Days 3, 24, and 29
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 58
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-08
Completion Date: 2014-06
Results First Posted: 2016-03-07
Last Update Posted: 2016-03-07
Locations: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Beijing, 100034, China
URL: https://clinicaltrials.gov/show/NCT01667900