A Study of LY2963016 in Healthy Participants

NCT01634165 | Completed Phase 1 Results

• 2 other identifiers: 14676I4L-MC-ABEM
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)]

  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.

  Predose up to 24 hours after administration of study drug

• Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)

  Predose up to 24 hours after administration of study drug

Secondary Outcomes (4)

• Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus

  Predose up to 24 hours after administration of study drug

• Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) From Time Zero to Last Measured Concentration Value [AUC(0-tlast)] of LY2963016 or Lantus

  Predose up to 24 hours after administration of study drug

• Maximum Glucose Infusion Rate (Rmax)

  Postdose up to 24 hours after administration of study drug

• Total Amount of Glucose Infused (Gtot)

  Postdose up to 24 hours after administration of study drug

Study Arms (4)

0.3 U/kg LY2963016

EXPERIMENTAL

Single 0.3 units/kilogram (U/kg) subcutaneous dose of LY2963016

Drug: LY2963016

0.3 U/kg Lantus

EXPERIMENTAL

Single 0.3 U/kg subcutaneous dose of Lantus

Drug: Lantus

0.6 U/kg LY2963016

EXPERIMENTAL

Single 0.6 U/kg subcutaneous dose of LY2963016

Drug: LY2963016

0.6 U/kg Lantus

EXPERIMENTAL

Single 0.6 U/kg subcutaneous dose of Lantus

Drug: Lantus

Interventions

LY2963016 DRUG

Administered subcutaneously

0.3 U/kg LY2963016; 0.6 U/kg LY2963016

Lantus DRUG

Administered subcutaneously

0.3 U/kg Lantus; 0.6 U/kg Lantus

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, 117597, Singapore

Location

MeSH Terms

Interventions

LY2963016 insulin glargine; Insulin Glargine

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: July 6, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 7, 2014
• Results First Posted: October 7, 2014

Record last verified: 2014-10

Locations

SG (1)