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Diabetes MellitusPhase 1NCT01476345

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

A Phase 1 study testing LY2963016 and Lantus in people with Diabetes Mellitus, run by Eli Lilly and Company at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus
What is being tested?
LY2963016 and Lantus
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSouth Africa
Study dates
Nov 2011to Jul 2012
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

South Africa1 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

Other trials in South Africa

About this study

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

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.

Being tested
LY2963016, Lantus
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY2963016Drug

    Administered subcutaneously

  • LantusDrug

    Administered subcutaneously

Study groups in NCT01476345
Study groupRoleWhat they receive
LY2963016ExperimentalA single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days.
Receives: Drug: LY2963016
LantusExperimentalA single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days.
Receives: Drug: Lantus

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

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

Secondary outcomes (2)

  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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01476345
Sponsor's protocol ID
13711
Other IDs
I4L-MC-ABEA
Status last verified
Oct 2014
First submitted
5 Oct 2011
Last updated
7 Oct 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2963016 and Lantus in people with Diabetes Mellitus, run by Eli Lilly and Company at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01476345.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2014.

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