A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY2963016 to Lantus in Healthy Subjects | RxWiki

A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY2963016 to Lantus in Healthy Subjects

Overview[ - collapse ][ - ]

Purpose	The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy subjects. Each study period will be approximately 8.5 days (1.5 days for treatment and 7 day washout period). There are 4 study periods.
Condition	Diabetes Mellitus
Intervention	Drug: LY2963016 Drug: Lantus
Phase	Phase 1
Sponsor	Eli Lilly and Company
Responsible Party	Eli Lilly and Company
ClinicalTrials.gov Identifier	NCT01476345
First Received	October 5, 2011
Last Updated	July 30, 2012
Last verified	July 2012

Tracking Information[ + expand ][ + ]

First Received Date	October 5, 2011
Last Updated Date	July 30, 2012
Start Date	November 2011
Estimated Primary Completion Date	July 2012
Current Primary Outcome Measures	Pharmacokinetics: area under the concentration-time curve (AUC) of LY2963016 and Lantus [Time Frame: One hour before dosing up to 24 hours post clamp procedure in all treatment periods] [Designated as safety issue: No] Pharmacokinetics: maximum plasma concentration (Cmax) of LY2963016 and Lantus [Time Frame: One hour before dosing up to 24 hours post clamp procedure in all treatments periods] [Designated as safety issue: No]
Current Secondary Outcome Measures	Maximum glucose infusion rate (Rmax) [Time Frame: One hour before dosing up to end of clamp procedure (24 hours post dose) in all treatment periods] [Designated as safety issue: No] Total amount of glucose infused (Gtot) over the duration of clamp procedure [Time Frame: One hour before dosing up to end of clamp procedure (24 hours post dose) in all treatment periods] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY2963016 to Lantus in Healthy Subjects
Official Title	Bioequivalence Study Comparing the Pharmacokinetics and Pharmacodynamics of LY2963016 With Insulin Glargine in Healthy Volunteers
Brief Summary	The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy subjects. Each study period will be approximately 8.5 days (1.5 days for treatment and 7 day washout period). There are 4 study periods.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Condition	Diabetes Mellitus
Intervention	Drug: LY2963016 Administered subcutaneously Drug: Lantus Administered subcutaneously
Study Arm (s)	Experimental: LY2963016 A single 0.5 U/kg dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days. Experimental: Lantus A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	98
Estimated Completion Date	July 2012
Estimated Primary Completion Date	July 2012
Eligibility Criteria	Inclusion Criteria: - are overtly healthy males or females, as determined by medical history and physical examination - male subjects: agree to use a reliable method of birth control during the study. - female subjects of child-bearing potential must test negative for pregnancy at the time of enrollment and agree to either abstain from sexual activity or to use a medically accepted means of contraception when engaging in sexual intercourse throughout the study, or female subjects not of child-bearing potential due to surgical sterilization or menopause - have a body weight of at least 55 kg, and body mass index (BMI) of 18.5 to 32.0 kg/m2 - have clinical laboratory test results within normal reference range for the population - have venous access sufficient to allow for blood sampling - are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures - have given written informed consent - Subjects should have a normal oral glucose tolerance test Exclusion Criteria: - are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product other than the investigational product used in this study; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study - have known allergies to heparin, insulin glargine, related compounds or any components of the formulation - are persons who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY2963016 - have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study - have an abnormal blood pressure as determined by the investigator - have a significant history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication - show evidence of significant active neuropsychiatric disease - regularly use known drugs of abuse and/or show positive findings on urinary drug screening - show evidence of human immunodeficiency virus infection and/or positive human HIV antibodies - show evidence of hepatitis C and/or positive hepatitis C antibody - show evidence of hepatitis B and/or positive hepatitis B surface antigen - are women with a positive pregnancy test or women who are lactating - intend to use over-the-counter or prescription medication - have donated blood of more than 500 mL within the last 56 days before dosing of Period 1 - have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to stop alcohol consumption for 24 hours before dosing and throughout the duration of each study period - smoke more than 10 cigarettes (or equivalent other tobacco products) per day - have a fasting blood glucose > 5.5 mmol/L (>99 mg/dL) at screening - have a positive test for anti-LY2963016 or anti-glargine antibodies
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	South Africa

Administrative Information[ + expand ][ + ]

NCT Number	NCT01476345
Other Study ID Numbers	13711
Has Data Monitoring Committee	No
Information Provided By	Eli Lilly and Company
Study Sponsor	Eli Lilly and Company
Collaborators	Not Provided
Investigators	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
Verification Date	July 2012

Locations[ + expand ][ + ]

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.	Bloemfontein, South Africa, 9301