A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects
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|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|
|Actual Primary Completion Date :||July 2011|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|