HealthyPhase 1NCT01688635

A Study to Compare LY2963016 and US-approved Lantus® After Single Dose Administration to Healthy Participants

A Phase 1 study testing LY2963016 and US Approved Lantus in people with Healthy, 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

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LY2963016 and US Approved Lantus
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 1 siteSingapore
Study dates: Sep 2012to Feb 2013
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

Are overtly healthy males or females
Have body mass index between 18.5 and 29.9 kilograms per meter square (kg/m^2)
Are nonsmokers and have not smoked for at least 2 months prior to entering the study
Have normal blood pressure and pulse rates at screening
Have electrocardiograms (ECGs) at screening considered as within normal limits
Have clinical laboratory test results within normal reference ranges

Who cannot join

Are currently enrolled in or discontinued within the last 30 days from a clinical study involving an investigational drug or device or are concurrently enrolled in any other type of medical research
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
Show evidence of significant active neuropsychiatric disease, including taking prescription medication for such diseases
Show evidence of current use of known drugs of abuse or a history of use within the past year
Have a history of first-degree relatives known to have diabetes mellitus

Show all 11Show fewer

Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening
Have positive hepatitis B surface antigen at screening
Intend to use over-the-counter or prescription medication within 7 or 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement medication, or birth control methods)
Have donated or had a blood loss of 450 milliliters (mL) within 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 24 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: Comparative Pharmacokinetics and Pharmacodynamics of LY2963016 and US-Approved Lantus® After Single-Dose Subcutaneous Administration to Healthy Subjects

The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of LY2963016 and US-approved Lantus®. The study involves four single injections; two doses of LY2963016 and two doses of US-approved Lantus®. The study will have 4 periods. In each period, a single injection will be administered before undergoing a euglycemic clamp that lasts for 24 hours. There will be at least a 7 day washout between each period. Side effects will be documented. Study participation is expected to last up to 14 weeks.

Conditions: Healthy
Being tested: LY2963016, US Approved Lantus
Keywords: Volunteers

What participants receive

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

LY2963016Drug
Administered subcutaneously
US Approved LantusDrug
Administered subcutaneously

Study groups in NCT01688635
Study group	Role	What they receive
LY2963016	Experimental	Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously, twice during the study Receives: Drug: LY2963016
US-approved Lantus	Experimental	Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously, twice during the study Receives: Drug: US Approved Lantus

What is being measured

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

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2963016 and US-Approved Lantus
The AUC from time 0 to 24 hours (AUC0-24) of LY2963016 and US-Approved Lantus was measured.
Measured: 30 minutes predose up to 24 hours postdose in all treatment periods
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2963016 and US-Approved Lantus
Measured: 30 minutes predose up to 24 hours postdose in all treatment periods

Secondary outcomes (2)

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 US-approved Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.
Measured: 30 minutes predose up to 24 hours postdose in all treatment periods
Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure
Gtot was the total glucose infusion over the clamp duration and was used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations were held constant after the administration of LY2963016 or US-approved Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.
Measured: 30 minutes 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.

Sep 2012Feb 2013

First posted20 Sep 2012 (estimated)
Study startSep 2012
Primary completionFeb 2013
Study completionFeb 2013

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 HealthyStudies 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: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01688635
Sponsor's protocol ID: 14973
Other IDs: I4L-MC-ABEO
Status last verified: Oct 2014
First submitted: 17 Sep 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?

See locations

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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: Comparative Pharmacokinetics and Pharmacodynamics of LY2963016 and US-Approved Lantus® After Single-Dose Subcutaneous Administration to Healthy Subjects
ClinicalTrials.gov ID: NCT01688635
Acronym / sponsor ID: 14973
Conditions: Healthy
Keywords: Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2012
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 20 Sep 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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
LY2963016	Experimental	Drug: LY2963016Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously, twice during the study
US-approved Lantus	Experimental	Drug: US Approved LantusSingle 0.5 U/kg dose of US-approved Lantus administered subcutaneously, twice during the study

Who may qualify

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

Key inclusion criteria (6 listed)

Are overtly healthy males or females
Have body mass index between 18.5 and 29.9 kilograms per meter square (kg/m^2)
Are nonsmokers and have not smoked for at least 2 months prior to entering the study
Have normal blood pressure and pulse rates at screening
Have electrocardiograms (ECGs) at screening considered as within normal limits

Key exclusion criteria (11 listed)

Are currently enrolled in or discontinued within the last 30 days from a clinical study involving an investigational drug or device or are concurrently enrolled in any other type of medical research
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
Show evidence of significant active neuropsychiatric disease, including taking prescription medication for such diseases
Show evidence of current use of known drugs of abuse or a history of use within the past year

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	LY2963016
US Approved LantusAdministered subcutaneously	Drug	US-approved Lantus

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2963016 and US-Approved Lantus
Time frame: 30 minutes predose up to 24 hours postdose in all treatment periods
The AUC from time 0 to 24 hours (AUC0-24) of LY2963016 and US-Approved Lantus was measured.
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2963016 and US-Approved Lantus
Time frame: 30 minutes predose up to 24 hours postdose in all treatment periods

2 secondary outcomes

Maximum Glucose Infusion Rate (Rmax)
Time frame: 30 minutes predose up to 24 hours postdose in all treatment periods
Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure
Time frame: 30 minutes predose up to 24 hours postdose in all treatment periods

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
LY/Lantus/LY/Lantus	45	45
Lantus/LY/Lantus/LY	46	46

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2963016 and US-Approved Lantus

Time frame: 30 minutes predose up to 24 hours postdose in all treatment periods. Geometric mean (Geometric Coefficient of Variation). Unit: picomoles*hour/liter (pmol*h/L)

Measure	LY2963016 n = 87	US-approved Lantus n = 89
Value	1720 (42)	1900 (35)

Population analysed: Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.

Primary outcome: Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2963016 and US-Approved Lantus

Time frame: 30 minutes predose up to 24 hours postdose in all treatment periods. Geometric mean (Geometric Coefficient of Variation). Unit: picomoles/liter (pmol/L)

Measure	LY2963016 n = 88	US-approved Lantus n = 89
Value	103 (41)	111 (34)

Population analysed: Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate Cmax. Participants were analyzed based on the treatment they received

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Randomization to study completion. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY2963016	0 of 89 (0%)	42 of 89 (47.2%)	Not reported
US-approved Lantus	0 of 90 (0%)	42 of 90 (46.7%)	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 US Approved Lantus in people with Healthy, 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 6 inclusion and 11 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 (PK): Area Under the Concentration Time Curve (AUC) of LY2963016 and US-Approved Lantus (time frame: 30 minutes 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 NCT01688635.

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.