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Healthy VolunteersPhase 1NCT01871493

A Study of LY2605541 and Insulin Lispro Mixture in Healthy Participants

A Phase 1 study testing LY2605541 and 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 main purpose of this study is to evaluate how the body absorbs and removes LY2605541, insulin lispro, and a mixture of both from the blood. The study has two parts. Participants may enroll in only one part. Each part has four treatment periods in a fixed order. 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?
LY2605541 and Insulin Lispro
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSingapore
Study dates
Jun 2013to Sep 2013
Phase
Phase 1
Are there results?
None posted in the registry

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 not of child-bearing potential
  • Have a body mass index (BMI) between 18 and 29.9 kilograms per meter squared (kg/m^2), inclusive
  • Are nonsmokers or have not smoked for at least 2 months prior to entering the study

Who cannot join

  • Have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin
  • Have a history of first-degree relatives known to have diabetes mellitus
  • Have used systemic glucocorticoids within 3 months prior to entry into the study
  • Have donated blood or had a blood loss of 450 milliliter (mL) within 1 month prior to study enrollment

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: A Phase 1 Study to Evaluate the Pharmacokinetics of LY2605541 Injection and Insulin Lispro Injection Administered as Mixture or as Individual Components in Healthy Subjects

The main purpose of this study is to evaluate how the body absorbs and removes LY2605541, insulin lispro, and a mixture of both from the blood. The study has two parts. Participants may enroll in only one part. Each part has four treatment periods in a fixed order. The study will last approximately 8 weeks, not including screening. Screening is required within 28 days prior to the start of the study.

Being tested
LY2605541, Insulin Lispro

What participants receive

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

  • LY2605541Drug

    Administered subcutaneous (SQ)

  • Insulin LisproDrug

    Also called Humalog

    Administered SQ

Study groups in NCT01871493
Study groupRoleWhat they receive
LY2605541-Part AExperimental1.42 units per kilogram (U/kg) of LY2605541 given once daily (QD) for 1 day, subcutaneously (SQ) in 1 of 4 treatment periods.
Receives: Drug: LY2605541
Insulin Lispro-Part AActive comparatorSingle dose 0.36 U/kg of insulin lispro given QD for 1 day, SQ in 1 of 4 treatment periods.
Receives: Drug: Insulin Lispro
LY2605541/Lispro Mix 1-Part AExperimentalSingle dose 0.54 U/kg of LY2605541 and 0.36 U/kg insulin lispro mixture given QD for 1 day, SQ in 1 of 4 treatment periods.
Receives: Drug: LY2605541; Drug: Insulin Lispro
LY2605541/Lispro Mix 2-Part AExperimentalSingle dose 1.42 U/kg of LY2605541 and 0.36 insulin lispro mixture given QD for 1 day, SQ in 1 of 4 treatment periods.
Receives: Drug: LY2605541; Drug: Insulin Lispro
Insulin Lispro-Part BActive comparator0.18 U/kg insulin lispro given twice daily (BID) for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.
Receives: Drug: Insulin Lispro
LY2605541/Lispro Mix-Part BExperimental0.71 U/kg LY2605541 and 0.18 U/kg insulin lispro mixture given BID for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.
Receives: Drug: LY2605541; Drug: Insulin Lispro
LY2605541 QD-Part BExperimental0.54 U/kg of LY2605541 given QD for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.
Receives: Drug: LY2605541
LY2605541 BID-Part BExperimental0.71 U/kg of LY2605541 given BID for 1 day SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.
Receives: Drug: LY2605541

What is being measured

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

  1. Pharmacokinetics (PK): Time to Reach Peak Concentration (tmax) of LY2605541 and Insulin Lispro

    Measured: Pre-dose up to 216 hours post-dose

  2. Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY2605541 and Insulin Lispro

    Measured: Pre-dose up to 216 hours post-dose

  3. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-∞) of LY2605541 and Insulin Lispro

    Measured: Pre-dose up to 216 hours post-dose

Secondary outcomes (2)

  1. Maximum Glucose Infusion Rate (Rmax)

    Measured: Predose up to 32 hours post clamp procedure in all treatment periods

  2. Total Glucose Infused Over Clamp Duration (Gtot)

    Measured: Predose up to 32 hours post clamp procedure 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 posted6 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionSep 2013
  4. Study completionSep 2013

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
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01871493
Sponsor's protocol ID
14833
Other IDs
I6O-FW-BHBA
Status last verified
Oct 2014
First submitted
4 Jun 2013
Last updated
21 Oct 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2605541 and 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 3 inclusion and 4 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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): Time to Reach Peak Concentration (tmax) of LY2605541 and Insulin Lispro (time frame: Pre-dose up to 216 hours post-dose). 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 NCT01871493.

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 Oct 2014.

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