A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects
|ClinicalTrials.gov Identifier: NCT01374178|
Recruitment Status : Completed
First Posted : June 15, 2011
Results First Posted : October 7, 2014
Last Update Posted : October 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Drug: LY2963016 Drug: Lantus||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Relative Bioavailability of LY2963016 to LANTUS® After Single Dose Subcutaneous Administration to Healthy Subjects|
|Study Start Date :||June 2011|
|Primary Completion Date :||July 2011|
|Study Completion Date :||July 2011|
A single 0.5-unit per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously.
Active Comparator: Lantus
A single 0.5-U/kg dose of Lantus will be administered subcutaneously.
Other Name: Insulin Glargine
- Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) [ Time Frame: Periods 1 and 2: Baseline up to 24 hours ]AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure.
- Pharmacokinetics: Maximum Concentration (Cmax) [ Time Frame: Periods 1 and 2: Baseline up to 24 hours ]
- Maximum Glucose Infusion Rate (Rmax) [ Time Frame: Periods 1 and 2: Baseline up to 24 hours ]
- Total Glucose Infused (Gtot) [ Time Frame: Periods 1 and 2: Baseline up to 24 hours ]
- Time of Maximum Glucose Infusion Rate (tRmax) [ Time Frame: Periods 1 and 2: Baseline up to 24 hours ]
- Number of Participants With Clinically Significant Effects [ Time Frame: Baseline up to 30 days ]Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374178
|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.|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|