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CompletedNCT02111083Updated May 21, 2015Results posted

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

A Phase 1 interventional study of Insulin Lispro in Healthy Volunteers, sponsored by Eli Lilly and Company. Completed at 1 site in Singapore. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-21.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.
  • 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.
02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.

Browse Eli Lilly and Company studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
38 participants (actual)

Study arms

  • Active comparator
    Insulin Lispro A

    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 \[T\]).

    Biological: Insulin Lispro

  • Experimental
    Insulin Lispro B

    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 \[R\]).

    Biological: Insulin Lispro

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

  2. Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax)

    Time frame: Day 1, predose through 8 hours post dose in each period

  3. Pharmacokinetic Parameter: Area Under the Curve(AUC)

    Time frame: Zero to infinity [AUC(0-∞)]

Secondary outcomes

  1. Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax)

    Time frame: Day 1, predose through 8 hours post dose in each period.

  2. Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)

    The total amount of glucose infused during the euglycemic clamp procedure.

    Time frame: Day1, predose through 8 hours post dose in each period.

  3. Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)

    The maximum observed glucose infusion rate during the euglycemic clamp procedure.

    Time frame: Day 1, predose through 8 hours post dose in each period.

  4. Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)

    Time frame: Day 1, predose through 8 hours post dose in each period.

07

Results

Posted May 21, 2015

Participant flow

First Intervention (1 Day)
Participant flow — First Intervention (1 Day)
MilestoneInsulin Lispro Dosing Sequence TRTRInsulin Lispro Dosing Sequence RTRT
Started1919
Completed1919
Not completed00
Interval Between Dosing (7-8 Days)
Participant flow — Interval Between Dosing (7-8 Days)
MilestoneInsulin Lispro Dosing Sequence TRTRInsulin Lispro Dosing Sequence RTRT
Started1919
Completed1919
Not completed00
Second Intervention (1 Day)
Participant flow — Second Intervention (1 Day)
MilestoneInsulin Lispro Dosing Sequence TRTRInsulin Lispro Dosing Sequence RTRT
Started1919
Completed1919
Not completed00
Interval Between Dosing (7-8 Days)
Participant flow — Interval Between Dosing (7-8 Days)
MilestoneInsulin Lispro Dosing Sequence TRTRInsulin Lispro Dosing Sequence RTRT
Started1919
Completed1919
Not completed00
Third Intervention (1 Day)
Participant flow — Third Intervention (1 Day)
MilestoneInsulin Lispro Dosing Sequence TRTRInsulin Lispro Dosing Sequence RTRT
Started1919
Completed1919
Not completed00
Interval Between Dosing (7-8 Days)
Participant flow — Interval Between Dosing (7-8 Days)
MilestoneInsulin Lispro Dosing Sequence TRTRInsulin Lispro Dosing Sequence RTRT
Started1919
Completed1818
Not completed11
Withdrew: Adverse event11
Fourth Intervention (1 Day)
Participant flow — Fourth Intervention (1 Day)
MilestoneInsulin Lispro Dosing Sequence TRTRInsulin Lispro Dosing Sequence RTRT
Started1818
Completed1818
Not completed00

Outcome measures

PrimaryPharmacokinetic 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.
Reported as:
Geometric mean · picomole*hour/liter (pmol*h/L)
Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast)
picomole*hour/liter (pmol*h/L)Insulin Lispro AInsulin Lispro B
Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast)2200 ± 162230 ± 17
Statistical analysis
  • Insulin Lispro A vs Insulin Lispro B · Ratio of geometric least square means: 0.986 · 90% CI 0.965 to 1.01
PrimaryPharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax)
Time frame:
Day 1, predose through 8 hours post dose in each period
Reported as:
Geometric mean · picomole/liter (pmol/L)
Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax)
picomole/liter (pmol/L)Insulin Lispro AInsulin Lispro B
Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax)744 ± 38851 ± 38
Statistical analysis
  • Insulin Lispro A vs Insulin Lispro B · Ratio of geometric least square means: 0.872 · 90% CI 0.828 to 0.919
SecondaryPharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax)
Time frame:
Day 1, predose through 8 hours post dose in each period.
Reported as:
Median · hours
Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax)
hoursInsulin Lispro AInsulin Lispro B
Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax)1 (0.5 to 3.0)1 (0.5 to 2.0)
Statistical analysis
  • Insulin Lispro A vs Insulin Lispro B · Median difference (final values): 0.25 · 90% CI 0 to 0.375
SecondaryPharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)

The total amount of glucose infused during the euglycemic clamp procedure.

Time frame:
Day1, predose through 8 hours post dose in each period.
Reported as:
Geometric mean · grams (g)
Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)
grams (g)Insulin Lispro AInsulin Lispro B
Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)120 ± 31120 ± 33
Statistical analysis
  • Insulin Lispro A vs Insulin Lispro B · Ratio of geometric least square means: 0.986 · 90% CI 0.954 to 1.02
SecondaryPharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)

The maximum observed glucose infusion rate during the euglycemic clamp procedure.

Time frame:
Day 1, predose through 8 hours post dose in each period.
Reported as:
Geometric mean · milligrams per minute (mg/min)
Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)
milligrams per minute (mg/min)Insulin Lispro AInsulin Lispro B
Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)503 ± 36526 ± 36
Statistical analysis
  • Insulin Lispro A vs Insulin Lispro B · Ratio of geometric least square means: 0.950 · 90% CI 0.901 to 1.00
SecondaryPharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)
Time frame:
Day 1, predose through 8 hours post dose in each period.
Reported as:
Geometric mean · hours
Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)
hoursInsulin Lispro AInsulin Lispro B
Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)2.71 ± 522.32 ± 52
Statistical analysis
  • Insulin Lispro A vs Insulin Lispro B · Difference of least squares means: 0.424 · 90% CI 0.164 to 0.685
PrimaryPharmacokinetic Parameter: Area Under the Curve(AUC)
Time frame:
Zero to infinity [AUC(0-∞)]
Reported as:
Geometric mean · picomole*hour/liter (pmol*h/L)
Pharmacokinetic Parameter: Area Under the Curve(AUC)
picomole*hour/liter (pmol*h/L)Insulin Lispro AInsulin Lispro B
Pharmacokinetic Parameter: Area Under the Curve(AUC)2330 ± 152360 ± 16
Statistical analysis
  • Insulin Lispro A vs Insulin Lispro B · Ratio of geometric least square means: 0.992 · 90% CI 0.975 to 1.01

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Insulin Lispro A—0/38 (0%)21/38 (55.3%)
Insulin Lispro B—0/38 (0%)16/38 (42.1%)
Most frequent other events
Showing 10 of 12
Most frequent other events
EventInsulin Lispro AInsulin Lispro B
Catheter site related reactionGeneral disorders7/385/38
Infusion site painGeneral disorders5/384/38
Infusion site swellingGeneral disorders5/384/38
Infusion site bruisingGeneral disorders3/381/38
Injection site bruisingGeneral disorders3/381/38
Application site erythemaGeneral disorders2/381/38
PyrexiaGeneral disorders2/381/38
Vessel puncture site bruiseGeneral disorders1/382/38
Vessel puncture site painGeneral disorders2/381/38
ScratchInjury, poisoning and procedural complications2/380/38

Baseline characteristics

Age, Continuous
Age, Continuous(years)Insulin Lispro Dosing Sequence TRTRInsulin Lispro Dosing Sequence RTRTTotal
Mean32.9 ± 6.130.4 ± 8.231.7 ± 7.2
Sex: Female, Male
Sex: Female, Male(Participants)Insulin Lispro Dosing Sequence TRTRInsulin Lispro Dosing Sequence RTRTTotal
Female213
Male171835
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Insulin Lispro Dosing Sequence TRTRInsulin Lispro Dosing Sequence RTRTTotal
Hispanic or Latino000
Not Hispanic or Latino191938
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Insulin Lispro Dosing Sequence TRTRInsulin Lispro Dosing Sequence RTRTTotal
Singapore191938
08

Study locations

1 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, Singapore
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2014, a primary completion of Aug 2014 and a completion of Aug 2014. It does not say whether these dates are actual or estimated.

Results were first posted in May 2015, 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 8, 2014
First posted
Apr 10, 2014
Start
May 2014
Primary completionActual
Aug 2014
CompletionActual
Aug 2014
Results first posted
May 21, 2015
Last update
May 21, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02111083
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Apr 10, 2014
Start date
May 2014
Primary completion
Aug 2014
Completion
Aug 2014
Results posted
May 21, 2015
Last update
May 21, 2015

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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