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Clinical Trial Details

Trial ID: L3819
Source ID: NCT01358981
Associated Drug: Ly2881835
Title: A Study of LY2881835 in Healthy People and People With Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01358981/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: LY2881835|DRUG: Placebo
Outcome Measures: Primary: Number of Participants With Clinically Significant Adverse Effects, Clinically significant adverse effects are treatment emergent adverse events (TEAEs) possibly related to study drug., Baseline to study completion up to 3 months | Secondary: Pharmacokinetics (PK): Area Under the Curve (AUC) of LY2881835, Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only AUC from time zero to 24 hours \[AUC(0-24 hours)\] is provided., Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24hours (h) post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose|Pharmacokinetics (PK): Maximum Concentration (Cmax) Of LY2881835, Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only Cmax up to 24 hours post-dose is provided., Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose|Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY2881835, Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only Tmax up to 24 hours post dose is provided., Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose|Glucose Area Under the Effective Concentration Curve (AUEC), Glucose area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 24 hours., Part A: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose|Glucagon-Like Peptide (Active GLP-1) Area Under the Effective Concentration Curve (AUEC), Glucagon-like peptide (active GLP-1) area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 2.5 hours., Part A: Predose, 1.5 and 2.5 h post-dose; Part B: Predose, 1.5 and 2.5 h post-dose|C-Peptide Area Under the Effective Concentration Curve (AUEC), C-Peptide area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 6 hours., Part A: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 18
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2011-05-24
Completion Date: 2011-08-17
Results First Posted: 2019-06-19
Last Update Posted: 2019-06-19
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., Singapore, Singapore
URL: https://clinicaltrials.gov/show/NCT01358981