Healthy VolunteersPhase 1NCT01634165

A Study of LY2963016 in Healthy Participants

A Phase 1 study testing LY2963016 and Lantus in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in Singapore.

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

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. Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
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: 24 participants
Where: 1 siteSingapore
Study dates: Jul 2012to Sep 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 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

Are persons who have previously completed or withdrawn from this study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

Show all 13Show fewer

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)

Trial locations and contacts

1 site in 1 country.

Singapore1 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.
Singapore, 117597

Other trials in Singapore

About this study

Official title: Pharmacokinetics and Pharmacodynamics of LY2963016 Compared to Lantus® in Healthy Subjects Following Two Single Subcutaneous Doses

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
Being tested: LY2963016, Lantus

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 NCT01634165
Study group	Role	What they receive
0.3 U/kg LY2963016	Experimental	Single 0.3 units/kilogram (U/kg) subcutaneous dose of LY2963016 Receives: Drug: LY2963016
0.3 U/kg Lantus	Experimental	Single 0.3 U/kg subcutaneous dose of Lantus Receives: Drug: Lantus
0.6 U/kg LY2963016	Experimental	Single 0.6 U/kg subcutaneous dose of LY2963016 Receives: Drug: LY2963016
0.6 U/kg Lantus	Experimental	Single 0.6 U/kg subcutaneous dose of Lantus Receives: Drug: Lantus

What is being measured

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

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.
Measured: Predose up to 24 hours after administration of study drug
Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)
Measured: 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
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.
Measured: 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
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.
Measured: Predose up to 24 hours after administration of study drug
Maximum Glucose Infusion Rate (Rmax)
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.
Measured: Postdose up to 24 hours after administration of study drug
Total Amount of Glucose Infused (Gtot)
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.
Measured: Postdose up to 24 hours after administration of study drug

Timeline

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

Jul 2012Sep 2012

First posted6 Jul 2012 (estimated)
Study startJul 2012
Primary completionSep 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01634165
Sponsor's protocol ID: 14676
Other IDs: I4L-MC-ABEM
Status last verified: Oct 2014
First submitted: 2 Jul 2012
Last updated: 7 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics and Pharmacodynamics of LY2963016 Compared to Lantus® in Healthy Subjects Following Two Single Subcutaneous Doses
ClinicalTrials.gov ID: NCT01634165
Acronym / sponsor ID: 14676
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 6 Jul 2012 (estimated)
Results: Posted 7 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
0.3 U/kg LY2963016	Experimental	Drug: LY2963016Single 0.3 units/kilogram (U/kg) subcutaneous dose of LY2963016
0.3 U/kg Lantus	Experimental	Drug: LantusSingle 0.3 U/kg subcutaneous dose of Lantus
0.6 U/kg LY2963016	Experimental	Drug: LY2963016Single 0.6 U/kg subcutaneous dose of LY2963016
0.6 U/kg Lantus	Experimental	Drug: LantusSingle 0.6 U/kg subcutaneous dose of Lantus

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY2963016Administered subcutaneously	Drug	0.3 U/kg LY2963016, 0.6 U/kg LY2963016
LantusAdministered subcutaneously	Drug	0.3 U/kg Lantus, 0.6 U/kg Lantus

Primary outcome

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.
Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)
Time frame: Predose up to 24 hours after administration of study drug

4 secondary outcomes

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
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
Maximum Glucose Infusion Rate (Rmax)
Time frame: Postdose up to 24 hours after administration of study drug
Total Amount of Glucose Infused (Gtot)
Time frame: Postdose up to 24 hours after administration of study drug

Results and safety

Results posted to the registry on 7 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.3 U/kg LY, 0.6 U/kg LY, 0.3 U/kg Lantus, 0.6 U/kg Lantus	6	6
0.6 U/kg LY, 0.6 U/kg Lantus, 0.3 U/kg LY, 0.3 U/kg Lantus	6	6
0.3 U/kg Lantus, 0.3 U/kg LY, 0.6 U/kg Lantus, 0.6 U/kg LY	6	6
0.6 U/kg Lantus, 0.3 U/kg Lantus, 0.6 U/kg LY, 0.3 U/kg LY	6	6

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: picomoles*hour per liter (pmol*h/L)

Measure	0.3 U/kg LY2963016 n = 23	0.6 U/kg LY2963016 n = 24	0.3 U/kg Lantus n = 22	0.6 U/kg Lantus n = 24
Value	2330 (39)	4470 (15)	2390 (33)	4310 (51)

Population analysed: All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-∞). Participants were analyzed based on the treatment they received.

Primary outcome: Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)

Time frame: Predose up to 24 hours after administration of study drug. Geometric mean (Geometric Coefficient of Variation). Unit: picomoles per liter (pmol/L)

Measure	0.3 U/kg LY2963016 n = 23	0.6 U/kg LY2963016 n = 24	0.3 U/kg Lantus n = 23	0.6 U/kg Lantus n = 24
Value	108 (20)	180 (28)	105 (33)	174 (38)

Population analysed: All participants who received study drug and had sufficient pharmacokinetic data to calculate Cmax. Participants were analyzed based on the treatment they received.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.3 U/kg LY2963016	0 of 23 (0%)	4 of 23 (17.4%)	Not reported
0.6 U/kg LY2963016	0 of 24 (0%)	10 of 24 (41.7%)	Not reported
0.3 U/kg Lantus	0 of 23 (0%)	10 of 23 (43.5%)	Not reported
0.6 U/kg Lantus	1 of 24 (4.2%)	12 of 24 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2963016 and Lantus in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in Singapore.

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 10 inclusion and 13 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 Singapore. 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 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). 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 NCT01634165.

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.