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

Diabetes Mellitus Clinical Trial

Official title:

Bioequivalence Study Comparing the Pharmacokinetics and Pharmacodynamics of LY2963016 With Insulin Glargine in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476345
• Other study ID #: 13711
• Secondary ID: I4L-MC-ABEA
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2011
• Last updated: October 3, 2014
• Start date: November 2011
• Est. completion date: July 2012

Study information

• Verified date: October 2014
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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 participants.

Each study period will be approximately 8.5 days (1.5 days for treatment and 7 day washout period). There are 4 study periods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• are overtly healthy males or females, as determined by medical history and physical examination

• male participants: agree to use a reliable method of birth control during the study.

• female participants 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 participants not of child-bearing potential due to surgical sterilization or menopause

• have a body weight of at least 55 kilograms (kg), and body mass index (BMI) of 18.5 to 32.0 kilograms/square meter (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

• participants 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 (HIV) 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 milliliters (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 millimoles/Liter (mmol/L) [>99 milligrams/deciliter (mg/dL)]at screening

• have a positive test for anti-LY2963016 or anti-glargine antibodies

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• LY2963016
Administered subcutaneously
• Lantus
Administered subcutaneously

Locations

Country	Name	City	State
South Africa	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 and Lantus		1 hour predose up to 24 hours postdose in all treatment periods	No
Primary	Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2963016 and Lantus		1 hour predose up to 24 hours postdose in all treatment periods	No
Secondary	Maximum Glucose Infusion Rate (Rmax)	Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain target blood glucose level and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.	1 hour predose up to 24 hours postdose in all treatment periods	No
Secondary	Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure	Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.	1 hour predose up to 24 hours postdose in all treatment periods	No