Healthy VolunteersPhase 1NCT02111083

A Study of 2 Different Formulations of Insulin Lispro in Healthy Participants

A Phase 1 study testing Insulin Lispro 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

The study involves 4 injections of insulin lispro and its purpose is to: Determine if 2 formulations of insulin lispro are treated by the body in a similar way. Compare how the 2 formulations of insulin lispro affect blood sugar level. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Insulin Lispro
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteSingapore
Study dates: May 2014to Aug 2014
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Are healthy males or females
Body mass index (BMI) between 18.5 and 29.9 kilogram per meter squared (kg/m^2)
Are nonsmokers
Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and clinical laboratory test results within normal reference range at screening.

Who cannot join

History of first-degree relatives known to have diabetes mellitus
Evidence of significant active neuropsychiatric disease
Evidence of an acute infection with fever or infectious disease
Intend to use over-the-counter or prescription medication (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).
Have used systemic glucocorticoids within 3 months prior to entry into the study.
Have donated blood of 1 unit or more within the last 3 months prior to study entry

Show all 9Show fewer

Excessive alcohol intake
Have a fasting venous blood glucose (fasting blood glucose [FBG], plasma) >6 millimoles per liter (mmol/L) at screening
Have positive hepatitis B surface antigen.

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: Evaluation of the Bioequivalence of Two Formulations of Insulin Lispro in Healthy Subjects

The study involves 4 injections of insulin lispro and its purpose is to:

Determine if 2 formulations of insulin lispro are treated by the body in a similar way.
Compare how the 2 formulations of insulin lispro affect blood sugar level.
Determine the safety of each insulin lispro formulations and any side effects that might be associated with them when given to healthy participants. The study is expected to last up to approximately 9 weeks for each participant.

Conditions: Healthy Volunteers
Being tested: Insulin Lispro

What participants receive

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

Insulin LisproBiological
LY275585 administered SC.

Study groups in NCT02111083
Study group	Role	What they receive
Insulin Lispro A	Active comparator	Insulin Lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200)administered subcutaneously (SC) once in two of four study periods.(Two doses of test [T]). Receives: Biological: Insulin Lispro
Insulin Lispro B	Experimental	Insulin Lispro B 20 units (U) of strength 100 U/mL (U-100) administered SC once in two of four study periods.(Two doses of reference [R]). Receives: Biological: Insulin Lispro

What is being measured

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

Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast)
Measured: Day 1, predose through 8 hours post dose in each period.
Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax)
Measured: Day 1, predose through 8 hours post dose in each period
Pharmacokinetic Parameter: Area Under the Curve(AUC)
Measured: Zero to infinity [AUC(0-∞)]

Secondary outcomes (4)

Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax)
Measured: Day 1, predose through 8 hours post dose in each period.
Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)
The total amount of glucose infused during the euglycemic clamp procedure.
Measured: Day1, predose through 8 hours post dose in each period.
Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)
The maximum observed glucose infusion rate during the euglycemic clamp procedure.
Measured: Day 1, predose through 8 hours post dose in each period.
Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)
Measured: Day 1, predose through 8 hours post dose in each period.

Timeline

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

May 2014Aug 2014

First posted10 Apr 2014 (estimated)
Study startMay 2014
Primary completionAug 2014
Study completionAug 2014

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: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02111083
Sponsor's protocol ID: 15418
Other IDs: F3Z-EW-IOQM
Status last verified: May 2015
First submitted: 8 Apr 2014
Last updated: 21 May 2015
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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Study at a glance

From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Bioequivalence of Two Formulations of Insulin Lispro in Healthy Subjects
ClinicalTrials.gov ID: NCT02111083
Acronym / sponsor ID: 15418
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: May 2014
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 10 Apr 2014 (estimated)
Results: Posted 21 May 2015

Clinical summary

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

The study involves 4 injections of insulin lispro and its purpose is to:

Determine if 2 formulations of insulin lispro are treated by the body in a similar way.
Compare how the 2 formulations of insulin lispro affect blood sugar level.
Determine the safety of each insulin lispro formulations and any side effects that might be associated with them when given to healthy participants. The study is expected to last up to approximately 9 weeks for each participant.

Study design

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

Arm	Type	Receives
Insulin Lispro A	Active comparator	Biological: Insulin LisproInsulin Lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200)administered subcutaneously (SC) once in two of four study periods.(Two doses of test [T]).
Insulin Lispro B	Experimental	Biological: Insulin LisproInsulin Lispro B 20 units (U) of strength 100 U/mL (U-100) administered SC once in two of four study periods.(Two doses of reference [R]).

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Are healthy males or females
Body mass index (BMI) between 18.5 and 29.9 kilogram per meter squared (kg/m^2)
Are nonsmokers
Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and clinical laboratory test results within normal reference range at screening.

Key exclusion criteria (9 listed)

History of first-degree relatives known to have diabetes mellitus
Evidence of significant active neuropsychiatric disease
Evidence of an acute infection with fever or infectious disease
Intend to use over-the-counter or prescription medication (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).
Have used systemic glucocorticoids within 3 months prior to entry into the study.

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
Insulin LisproLY275585 administered SC.	Biological	Insulin Lispro A, Insulin Lispro B

Primary outcome

Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast)
Time frame: Day 1, predose through 8 hours post dose in each period.
Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax)
Time frame: Day 1, predose through 8 hours post dose in each period
Pharmacokinetic Parameter: Area Under the Curve(AUC)
Time frame: Zero to infinity [AUC(0-∞)]

4 secondary outcomes

Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax)
Time frame: Day 1, predose through 8 hours post dose in each period.
Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)
Time frame: Day1, predose through 8 hours post dose in each period.
Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)
Time frame: Day 1, predose through 8 hours post dose in each period.
Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)
Time frame: Day 1, predose through 8 hours post dose in each period.

Results and safety

Results posted to the registry on 21 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Insulin Lispro Dosing Sequence TRTR	19	19
Insulin Lispro Dosing Sequence RTRT	19	19

Primary outcome: Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast)

Time frame: Day 1, predose through 8 hours post dose in each period.. Geometric mean (Geometric Coefficient of Variation). Unit: picomole*hour/liter (pmol*h/L)

Measure	Insulin Lispro A n = 38	Insulin Lispro B n = 38
Value	2200 (16)	2230 (17)

Insulin Lispro A vs Insulin Lispro B: Ratio of geometric least square means: 0.986 (90% CI 0.965 to 1.01)

Population analysed: All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.

Primary outcome: Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax)

Time frame: Day 1, predose through 8 hours post dose in each period. Geometric mean (Geometric Coefficient of Variation). Unit: picomole/liter (pmol/L)

Measure	Insulin Lispro A n = 38	Insulin Lispro B n = 38
Value	744 (38)	851 (38)

Insulin Lispro A vs Insulin Lispro B: Ratio of geometric least square means: 0.872 (90% CI 0.828 to 0.919)

Population analysed: All participants who had at least one study treatment and had evaluable PK data.

Primary outcome: Pharmacokinetic Parameter: Area Under the Curve(AUC)

Time frame: Zero to infinity [AUC(0-∞)]. Geometric mean (Geometric Coefficient of Variation). Unit: picomole*hour/liter (pmol*h/L)

Measure	Insulin Lispro A n = 38	Insulin Lispro B n = 38
Value	2330 (15)	2360 (16)

Insulin Lispro A vs Insulin Lispro B: Ratio of geometric least square means: 0.992 (90% CI 0.975 to 1.01)

Population analysed: All participants who had at least one study treatment and had evaluable PK data.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin Lispro A	0 of 38 (0%)	21 of 38 (55.3%)	Not reported
Insulin Lispro B	0 of 38 (0%)	16 of 38 (42.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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 Insulin Lispro 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 4 inclusion and 9 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 21 May 2015. 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 21 May 2015). 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?

Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast) (time frame: Day 1, predose through 8 hours post dose in each period.). The study lists 3 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 NCT02111083.

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 21 May 2015.