A Study of LY2963016 in Healthy Participants

• ClinicalTrials.gov Identifier: NCT01634165
• Recruitment Status: Completed
• First Posted: July 6, 2012
• Results First Posted: October 7, 2014
• Last Update Posted: October 7, 2014
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Study Description

Brief Summary:

This study involves 2 single injections of LY2963016 and 2 single injections of Lantus. There will be at least 6 days between each injection.

The study will compare LY2963016 to Lantus at two different doses.

This study is approximately 10 weeks long, not including screening. Screening is required within 4 weeks of the start of the study.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Drug: LY2963016; Drug: Lantus	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Pharmacokinetics and Pharmacodynamics of LY2963016 Compared to Lantus® in Healthy Subjects Following Two Single Subcutaneous Doses
• Study Start Date: July 2012
• Actual Primary Completion Date: September 2012
• Actual Study Completion Date: September 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: 0.3 U/kg LY2963016; Single 0.3 units/kilogram (U/kg) subcutaneous dose of LY2963016	Drug: LY2963016; Administered subcutaneously
Experimental: 0.3 U/kg Lantus; Single 0.3 U/kg subcutaneous dose of Lantus	Drug: Lantus; Administered subcutaneously
Experimental: 0.6 U/kg LY2963016; Single 0.6 U/kg subcutaneous dose of LY2963016	Drug: LY2963016; Administered subcutaneously
Experimental: 0.6 U/kg Lantus; Single 0.6 U/kg subcutaneous dose of Lantus	Drug: Lantus; Administered subcutaneously

Outcome Measures

Primary Outcome Measures :

1. Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)] [ Time Frame: Predose up to 24 hours after administration of study drug ]
   Results for LY2936016 treatment arms provide the AUC(0-∞) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-∞) for Lantus.
2. Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax) [ Time Frame: Predose up to 24 hours after administration of study drug ]

Secondary Outcome Measures :

1. Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus [ Time Frame: Predose up to 24 hours after administration of study drug ]
   Results for LY2936016 treatment arms provide the AUC(0-24) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-24) for Lantus.
2. Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) From Time Zero to Last Measured Concentration Value [AUC(0-tlast)] of LY2963016 or Lantus [ Time Frame: Predose up to 24 hours after administration of study drug ]
   Results for LY2936016 treatment arms provide the AUC(0-tlast) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-tlast) for Lantus.
3. Maximum Glucose Infusion Rate (Rmax) [ Time Frame: Postdose up to 24 hours after administration of study drug ]
   Rmax 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.
4. Total Amount of Glucose Infused (Gtot) [ Time Frame: Postdose up to 24 hours after administration of study drug ]
   Gtot 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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Healthy males or females
• Women must be either surgically sterile, post-menopausal, or agree to use a reliable method of birth control during the study
• Have a body mass index between 18.5 and 29.9 kilograms per meter squared (kg/m²)
• Are nonsmokers and have not smoked for at least 6 months prior to entering the study
• Have normal blood pressures and pulse rates at screening, as determined by the investigator
• Have an electrocardiogram (ECG) at screening considered as within normal limits by the investigator
• Have clinical laboratory test results within normal reference range for the population
• Have fasting plasma glucose <110 milligrams per deciliter (mg/dL) (<6.0 micromoles per liter [mmol/L]) at screening
• Have venous access sufficient to allow for blood sampling, intravenous drug administration, and clamp procedures as per the protocol
• Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site

Exclusion Criteria:

• Are persons who have previously completed or withdrawn from this study
• Are currently enrolled in or have discontinued within the last 30 days from a clinical trial involving an investigational drug or device 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 insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin
• Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
• Show evidence of significant active neuropsychiatric disease
• Show evidence of current use of known drugs of abuse or have a history of use within the past year
• Have a history of first-degree relatives known to have diabetes mellitus
• Show evidence of an acute infection with fever or infectious disease at the time of study entry
• Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening
• Have positive hepatitis B surface antigens at screening
• Intend to use over-the-counter medication within 7 days or prescription medication within 14 days prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement, or birth control methods)
• Have donated blood or had a blood loss of 450 milliliters (mL) 3 months prior to study enrollment
• 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 from 48 hours prior to each dosing until discharged from the clinical research unit (CRU)

Contacts and Locations

Locations

Singapore

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, 117597

Sponsors and Collaborators

Eli Lilly and Company

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

More Information

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT01634165
• Other Study ID Numbers: 14676; I4L-MC-ABEM ( Other Identifier: Eli Lilly and Company )
• First Posted: July 6, 2012
• Results First Posted: October 7, 2014
• Last Update Posted: October 7, 2014
• Last Verified: October 2014

Additional relevant MeSH terms:

Insulin Glargine; Hypoglycemic Agents; Physiological Effects of Drugs