Healthy VolunteersPhase 1NCT01133392
Bioequivalence of Two Lispro Formulations
A Phase 1 study testing Insulin lispro A and Insulin lispro B in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Insulin lispro A and Insulin lispro B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSingapore
- Study dates
- May 2010to Aug 2010
- 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 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 kilograms 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.
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- Excessive alcohol intake
- Have a fasting venous blood glucose (FBG, plasma) >6 millimoles/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
About this study
Official title: Evaluation of the Bioequivalence of Two Formulations of Insulin Lispro in Healthy Subjects
This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.
Read the detailed description
The 2 formulations of insulin lispro will be referred to here as:
Lispro A
Lispro B
- Conditions
- Healthy Volunteers
- Being tested
- Insulin lispro A, Insulin lispro B
- Keywords
- insulin, lispro
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin lispro ADrug
Also called LY275585
20 units (U) subcutaneously (SC).
Insulin lispro BDrug
Also called LY275585
20 U subcutaneously (SC).
| Study group | Role | What they receive |
|---|---|---|
| Insulin Lispro A | Experimental | 20 units (U) subcutaneously (SC) Receives: Drug: Insulin lispro A |
| Insulin lispro B | Active comparator | 20 units (U) subcutaneously (SC) Receives: Drug: Insulin lispro B |
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 Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast]
Primary outcome measure is based on the pharmacokinetic area under the concentration-time curve from time 0 to the last time point with a measurable concentration.
Measured: 0 up to 8 hours post dose
Secondary outcomes (4)
Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax]
The maximum observed insulin lispro concentration following dosing.
Measured: 0 to 8 hours post dose
Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)
The maximum observed glucose infusion rate during the euglycemic clamp procedure.
Measured: 0 to 8 hours post dose
Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)
Time of maximal glucose infusion rate.
Measured: 0 to 8 hours post dose
Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)
The total amount of glucose infused during the euglycemic clamp procedure.
Measured: 0 to 8 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2010
- Study completionAug 2010
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133392
- Sponsor's protocol ID
- 13300
- Other IDs
- F3Z-EW-IOPY
- Status last verified
- Dec 2014
- First submitted
- 27 May 2010
- Last updated
- 30 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. 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
- NCT01133392
- Acronym / sponsor ID
- 13300
- Conditions
- Healthy Volunteers
- Keywords
- insulin, lispro
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 28 May 2010 (estimated)
- Results
- Posted 30 Dec 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 will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.
Detailed description
The 2 formulations of insulin lispro will be referred to here as:
Lispro A
Lispro B
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Lispro A | Experimental | Drug: Insulin lispro A20 units (U) subcutaneously (SC) |
| Insulin lispro B | Active comparator | Drug: Insulin lispro B20 units (U) subcutaneously (SC) |
Who may qualify
- Ages
- 21 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 kilograms 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 lispro AAlso: LY27558520 units (U) subcutaneously (SC). | Drug | Insulin Lispro A |
| Insulin lispro BAlso: LY27558520 U subcutaneously (SC). | Drug | Insulin lispro B |
Primary outcome
Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast]
Time frame: 0 up to 8 hours post dose
Primary outcome measure is based on the pharmacokinetic area under the concentration-time curve from time 0 to the last time point with a measurable concentration.
4 secondary outcomes
Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax]
Time frame: 0 to 8 hours post dose
Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)
Time frame: 0 to 8 hours post dose
Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)
Time frame: 0 to 8 hours post dose
Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)
Time frame: 0 to 8 hours post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 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 Insulin lispro A and Insulin lispro B 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 30 Dec 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 30 Dec 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?
Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast] (time frame: 0 up to 8 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2014.