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CompletedNCT01476345Updated Oct 7, 2014Results posted

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

A Phase 1 interventional study of LY2963016 and Lantus in Diabetes Mellitus, sponsored by Eli Lilly and Company. Completed at 1 site in South Africa. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-07.

Sponsored by Eli Lilly and Company · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus

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03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 80 is close to the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.

Browse Eli Lilly and Company studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    LY2963016

    A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days.

    Drug: LY2963016

  • Experimental
    Lantus

    A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days.

    Drug: Lantus

Interventions

  • DrugLY2963016

    Administered subcutaneously

  • DrugLantus

    Administered subcutaneously

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 and Lantus

    Time frame: 1 hour predose up to 24 hours postdose in all treatment periods

  2. Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2963016 and Lantus

    Time frame: 1 hour predose up to 24 hours postdose in all treatment periods

Secondary outcomes

  1. 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.

    Time frame: 1 hour predose up to 24 hours postdose in all treatment periods

  2. 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.

    Time frame: 1 hour predose up to 24 hours postdose in all treatment periods

07

Results

Posted Oct 7, 2014

Participant flow

Period 1
Participant flow — Period 1
MilestoneLY/Lantus/LY/LantusLantus/LY/Lantus/LY
Started4040
Received at least 1 dose of study drug4040
Completed4040
Not completed00
Period 2
Participant flow — Period 2
MilestoneLY/Lantus/LY/LantusLantus/LY/Lantus/LY
Started4040
Completed4040
Not completed00
Period 3
Participant flow — Period 3
MilestoneLY/Lantus/LY/LantusLantus/LY/Lantus/LY
Started3939
Completed3939
Not completed00
Period 4
Participant flow — Period 4
MilestoneLY/Lantus/LY/LantusLantus/LY/Lantus/LY
Started3939
Completed3939
Not completed00

Outcome measures

PrimaryPharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 and Lantus
Time frame:
1 hour predose up to 24 hours postdose in all treatment periods
Reported as:
Geometric mean · picomoles*hour/Liter (pmol*h/L)
Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 and Lantus
picomoles*hour/Liter (pmol*h/L)LY2963016Lantus
Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 and Lantus1810 ± 401980 ± 36
PrimaryPharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2963016 and Lantus
Time frame:
1 hour predose up to 24 hours postdose in all treatment periods
Reported as:
Geometric mean · picomoles/Liter (pmol/L)
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2963016 and Lantus
picomoles/Liter (pmol/L)LY2963016Lantus
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2963016 and Lantus112 ± 39119 ± 34
SecondaryMaximum 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.

Time frame:
1 hour predose up to 24 hours postdose in all treatment periods
Reported as:
Geometric mean · milligrams/kilogram/minute (mg/kg/min)
Maximum Glucose Infusion Rate (Rmax)
milligrams/kilogram/minute (mg/kg/min)LY2963016Lantus
Maximum Glucose Infusion Rate (Rmax)2.85 ± 462.88 ± 41
SecondaryTotal 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.

Time frame:
1 hour predose up to 24 hours postdose in all treatment periods
Reported as:
Geometric mean · milligrams/kilogram (mg/kg)
Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure
milligrams/kilogram (mg/kg)LY2963016Lantus
Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure2580 ± 452710 ± 40

Adverse events

Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LY2963016—0/80 (0%)50/80 (62.5%)
Lantus—0/80 (0%)54/80 (67.5%)
Most frequent other events
Most frequent other events
EventLY2963016Lantus
HeadacheNervous system disorders15/8025/80
Procedural site reactionInjury, poisoning and procedural complications17/8017/80
Injection site painGeneral disorders5/806/80
NauseaGastrointestinal disorders4/805/80
DiarrhoeaGastrointestinal disorders4/801/80
Injection site erythemaGeneral disorders4/802/80
DysmenorrhoeaReproductive system and breast disorders1/240/24

Baseline characteristics

All randomized participants.

Age, Continuous
Age, Continuous(years)All Participants
Mean32.0 ± 10.9
Sex: Female, Male
Sex: Female, Male(Participants)All Participants
Female24
Male56
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Participants
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American10
White64
More than one race6
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)All Participants
South Africa80
08

Study locations

1 site
  • 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, 9301, South Africa
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2011, a primary completion of Jul 2012 and a completion of Jul 2012. It does not say whether these dates are actual or estimated.

Results were first posted in Oct 2014, 2 years 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2011
First posted
Nov 22, 2011
Start
Nov 2011
Primary completionActual
Jul 2012
CompletionActual
Jul 2012
Results first posted
Oct 7, 2014
Last update
Oct 7, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01476345
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Nov 22, 2011
Start date
Nov 2011
Primary completion
Jul 2012
Completion
Jul 2012
Results posted
Oct 7, 2014
Last update
Oct 7, 2014

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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