Trial Outcomes & Findings for A Study of 2 Different Formulations of Insulin Lispro in Healthy Participants (NCT NCT02111083)
NCT ID: NCT02111083
Last Updated: 2015-05-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
Day 1, predose through 8 hours post dose in each period.
Results posted on
2015-05-21
Participant Flow
Participant milestones
| Measure |
Insulin Lispro Dosing Sequence TRTR
Each subject was administered insulin lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200) (test \[T\] on 2 occasions) and insulin lispro B 20 units (U) of strength 100 U/mL (U-100) (reference \[R\] on 2 occasions).Subjects were randomly assigned to dosing sequences TRTR.
|
Insulin Lispro Dosing Sequence RTRT
Each subject was administered insulin lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200) (test \[T\] on 2 occasions) and insulin lispro B 20 units (U) of strength 100 U/mL (U-100) (reference \[R\] on 2 occasions).Subjects were randomly assigned to dosing sequences RTRT.
|
|---|---|---|
|
First Intervention (1 Day)
STARTED
|
19
|
19
|
|
First Intervention (1 Day)
COMPLETED
|
19
|
19
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Interval Between Dosing (7-8 Days)
STARTED
|
19
|
19
|
|
Interval Between Dosing (7-8 Days)
COMPLETED
|
18
|
18
|
|
Interval Between Dosing (7-8 Days)
NOT COMPLETED
|
1
|
1
|
|
Second Intervention (1 Day)
STARTED
|
19
|
19
|
|
Second Intervention (1 Day)
COMPLETED
|
19
|
19
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Third Intervention (1 Day)
STARTED
|
19
|
19
|
|
Third Intervention (1 Day)
COMPLETED
|
19
|
19
|
|
Third Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Fourth Intervention (1 Day)
STARTED
|
18
|
18
|
|
Fourth Intervention (1 Day)
COMPLETED
|
18
|
18
|
|
Fourth Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Insulin Lispro Dosing Sequence TRTR
Each subject was administered insulin lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200) (test \[T\] on 2 occasions) and insulin lispro B 20 units (U) of strength 100 U/mL (U-100) (reference \[R\] on 2 occasions).Subjects were randomly assigned to dosing sequences TRTR.
|
Insulin Lispro Dosing Sequence RTRT
Each subject was administered insulin lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200) (test \[T\] on 2 occasions) and insulin lispro B 20 units (U) of strength 100 U/mL (U-100) (reference \[R\] on 2 occasions).Subjects were randomly assigned to dosing sequences RTRT.
|
|---|---|---|
|
Interval Between Dosing (7-8 Days)
Adverse Event
|
1
|
1
|
Baseline Characteristics
A Study of 2 Different Formulations of Insulin Lispro in Healthy Participants
Baseline characteristics by cohort
| Measure |
Insulin Lispro Dosing Sequence TRTR
n=19 Participants
Each subject was administered insulin lispro A U-200 (test \[T\] on 2 occasions) and insulin lispro B U-100(reference \[R\] on 2 occasions).Subjects were randomly assigned to dosing sequences TRTR.
|
Insulin Lispro Dosing Sequence RTRT
n=19 Participants
Each subject was administered insulin lispro A U-200 (test \[T\] on 2 occasions) and insulin lispro B U-100 (reference \[R\] on 2 occasions). Subjects were randomly assigned to dosing sequences RTRT.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.9 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
31.7 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1, predose through 8 hours post dose in each period.Population: All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.
Outcome measures
| Measure |
Insulin Lispro A
n=38 Participants
Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test \[T\]).
|
Insulin Lispro B
n=38 Participants
Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference \[R\]).
|
|---|---|---|
|
Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast)
|
2200 picomole*hour/liter (pmol*h/L)
Geometric Coefficient of Variation 16
|
2230 picomole*hour/liter (pmol*h/L)
Geometric Coefficient of Variation 17
|
PRIMARY outcome
Timeframe: Day 1, predose through 8 hours post dose in each periodPopulation: All participants who had at least one study treatment and had evaluable PK data.
Outcome measures
| Measure |
Insulin Lispro A
n=38 Participants
Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test \[T\]).
|
Insulin Lispro B
n=38 Participants
Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference \[R\]).
|
|---|---|---|
|
Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax)
|
744 picomole/liter (pmol/L)
Geometric Coefficient of Variation 38
|
851 picomole/liter (pmol/L)
Geometric Coefficient of Variation 38
|
PRIMARY outcome
Timeframe: Zero to infinity [AUC(0-∞)]Population: All participants who had at least one study treatment and had evaluable PK data.
Outcome measures
| Measure |
Insulin Lispro A
n=38 Participants
Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test \[T\]).
|
Insulin Lispro B
n=38 Participants
Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference \[R\]).
|
|---|---|---|
|
Pharmacokinetic Parameter: Area Under the Curve(AUC)
|
2330 picomole*hour/liter (pmol*h/L)
Geometric Coefficient of Variation 15
|
2360 picomole*hour/liter (pmol*h/L)
Geometric Coefficient of Variation 16
|
SECONDARY outcome
Timeframe: Day 1, predose through 8 hours post dose in each period.Population: All participants who had at least one study treatment and had evaluable PK data.
Outcome measures
| Measure |
Insulin Lispro A
n=38 Participants
Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test \[T\]).
|
Insulin Lispro B
n=38 Participants
Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference \[R\]).
|
|---|---|---|
|
Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax)
|
1 hours
Interval 0.5 to 3.0
|
1 hours
Interval 0.5 to 2.0
|
SECONDARY outcome
Timeframe: Day1, predose through 8 hours post dose in each period.Population: All participants who had at least one study treatment and had evaluable pharmacodynamic(PD) data.
The total amount of glucose infused during the euglycemic clamp procedure.
Outcome measures
| Measure |
Insulin Lispro A
n=38 Participants
Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test \[T\]).
|
Insulin Lispro B
n=38 Participants
Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference \[R\]).
|
|---|---|---|
|
Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)
|
120 grams (g)
Geometric Coefficient of Variation 31
|
120 grams (g)
Geometric Coefficient of Variation 33
|
SECONDARY outcome
Timeframe: Day 1, predose through 8 hours post dose in each period.Population: All participants who had at least one study treatment and had evaluable PD data.
The maximum observed glucose infusion rate during the euglycemic clamp procedure.
Outcome measures
| Measure |
Insulin Lispro A
n=38 Participants
Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test \[T\]).
|
Insulin Lispro B
n=38 Participants
Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference \[R\]).
|
|---|---|---|
|
Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)
|
503 milligrams per minute (mg/min)
Geometric Coefficient of Variation 36
|
526 milligrams per minute (mg/min)
Geometric Coefficient of Variation 36
|
SECONDARY outcome
Timeframe: Day 1, predose through 8 hours post dose in each period.Population: All participants who had at least one study treatment and had evaluable PD data.
Outcome measures
| Measure |
Insulin Lispro A
n=38 Participants
Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test \[T\]).
|
Insulin Lispro B
n=38 Participants
Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference \[R\]).
|
|---|---|---|
|
Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)
|
2.71 hours
Geometric Coefficient of Variation 52
|
2.32 hours
Geometric Coefficient of Variation 52
|
Adverse Events
Insulin Lispro A
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Insulin Lispro B
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Insulin Lispro A
n=38 participants at risk
Insulin Lispro A U-200 subcutaneously (SC) once in two of four study periods. (Two doses of test \[T\]).
|
Insulin Lispro B
n=38 participants at risk
Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference \[R\]).
|
|---|---|---|
|
General disorders
Application site erythema
|
5.3%
2/38 • Number of events 3
|
2.6%
1/38 • Number of events 2
|
|
General disorders
Catheter site related reaction
|
18.4%
7/38 • Number of events 9
|
13.2%
5/38 • Number of events 5
|
|
General disorders
Infusion site bruising
|
7.9%
3/38 • Number of events 3
|
2.6%
1/38 • Number of events 1
|
|
General disorders
Infusion site pain
|
13.2%
5/38 • Number of events 5
|
10.5%
4/38 • Number of events 4
|
|
General disorders
Infusion site swelling
|
13.2%
5/38 • Number of events 5
|
10.5%
4/38 • Number of events 5
|
|
General disorders
Injection site bruising
|
7.9%
3/38 • Number of events 3
|
2.6%
1/38 • Number of events 1
|
|
General disorders
Pyrexia
|
5.3%
2/38 • Number of events 2
|
2.6%
1/38 • Number of events 1
|
|
General disorders
Vessel puncture site bruise
|
2.6%
1/38 • Number of events 1
|
5.3%
2/38 • Number of events 2
|
|
General disorders
Vessel puncture site pain
|
5.3%
2/38 • Number of events 2
|
2.6%
1/38 • Number of events 1
|
|
Injury, poisoning and procedural complications
Scratch
|
5.3%
2/38 • Number of events 2
|
0.00%
0/38
|
|
Nervous system disorders
Headache
|
5.3%
2/38 • Number of events 2
|
2.6%
1/38 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
2/38 • Number of events 2
|
0.00%
0/38
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place