| Outcome Measures: |
Primary: Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs, The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module., Baseline through Day 28 | Secondary: Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385, LY3009385 exposure in terms of AUC from time 0 extrapolated to infinity (AUC\[0-inf\]) is summarized., Predose through Day 28|Pharmacokinetics: Maximum Concentration (Cmax), The maximum observed plasma concentration (Cmax) of LY3009385 is summarized., Predose through Day 28|Change in Level of Blood Glucose Before and After a Standard Meal, The effect of LY3009385 on postprandial blood glucose was evaluated. Change from baseline area under the glucose concentration-time curve from time 0 to 6 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm., Baseline, Day 5, and Day 14|Change in Level of C-peptide Before and After a Standard Meal, The effect of LY3009385 on postprandial c-peptide was assessed. Change from baseline area under the c-peptide concentration-time curve from time 0 to 4 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm., Baseline, Day 5, and Day 14|Change in Level of Glucagon Before and After a Standard Meal, The effect of LY3009385 on postprandial glucagon levels was assessed. Change from baseline glucagon concentrations 2 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) were calculated and summarized by treatment arm., Baseline, Day 14|Number of Participants Forming Antibody to LY3009385, The number of participants with postbaseline detection of LY3009385treatment-emergent (TE) antidrug antibodies (ADA), defined as a 4-fold increase in the ADA titer from baseline., Baseline through Day 28
|
| 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
|
