Trial Outcomes & Findings for A Study of Lispro Formulations in Healthy Participants (NCT NCT02293551)
NCT ID: NCT02293551
Last Updated: 2025-09-08
Results Overview
Primary outcome measure is based on the PK area under the concentration curve from 0 to infinity with a measurable concentration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
-30, 0 (Predose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, and 300 Minutes
Results posted on
2025-09-08
Participant Flow
Part A was a 5-period crossover study and Part B was a 4-period crossover study. A washout of 72 hours was observed between doses with a follow up within 7 to 14 days after the last dose.
Participant milestones
| Measure |
Part A: Lispro Sequence 1
Each participant received a single subcutaneous (SC) dose of 7.0 U insulin lispro (Reference) and 4 doses of different test insulin lispro formulations (7.28 U; Tests A, B, C, and D) in one of five periods according to assigned treatment sequence 1, 2, or 3.
Sequence 1: Test A, D, C, Reference, B
|
Part A: Lispro Sequence 2
Each participant received a single SC dose of 7.0 U insulin lispro (Reference) and 4 doses of different test insulin lispro formulations (7.28 U; Tests A, B, C, and D) in one of five periods according to assigned treatment sequence 1, 2, or 3.
Sequence 2: Test B, A, Reference, C, D
|
Part A: Lispro Sequence 3
Each participant received a single SC dose of 7.0 U insulin lispro (Reference) and 4 doses of different test insulin lispro formulations (7.28 U; Tests A, B, C, and D) in one of five periods according to assigned treatment sequence 1, 2, or 3.
Sequence 3: Test Reference, Test C, B, D, A.
|
Part B: Lispro Sequence 1
Each participant received a single dose of lispro SC in one of four periods according to assigned treatment sequence 1, 2, or 3. Participants received test formulation B containing 7.28 U (Units) of insulin lispro given as a single SC injection or test formulation B containing 15.47 U of insulin lispro given as a single SC injection or test formulation B containing 30.03 U of insulin lispro given as a single SC injection.
Sequence 1: 30.03 U, 7.28 U, 15.47 U, 7.28 U
|
Part B Lispro Sequence 2
Each participant received a single dose of lispro SC in one of four periods according to assigned treatment sequence 1, 2, or 3. Participants received test formulation B containing 7.28 U (Units) of insulin lispro given as a single SC injection or test formulation B containing 15.47 U of insulin lispro given as a single SC injection or test formulation B containing 30.03 U of insulin lispro given as a single SC injection.
Sequence 2: 7.28 U, 15.47 U, 30.03 U, 15.47 U
|
Part B Lispro Sequence 3
Each participant received a single dose of lispro SC in one of four periods according to assigned treatment sequence 1, 2, or 3. Participants received test formulation B containing 7.28 U (Units) of insulin lispro given as a single SC injection or test formulation B containing 15.47 U of insulin lispro given as a single SC injection or test formulation B containing 30.03 U of insulin lispro given as a single SC injection.
Sequence 3: 15.47 U, 30.03 U, 7.28 U, 30.03 U
|
|---|---|---|---|---|---|---|
|
Part A and Part B Period 1
STARTED
|
8
|
8
|
8
|
10
|
10
|
10
|
|
Part A and Part B Period 1
COMPLETED
|
8
|
8
|
8
|
10
|
10
|
10
|
|
Part A and Part B Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A and B Period 2
STARTED
|
8
|
8
|
8
|
10
|
10
|
10
|
|
Part A and B Period 2
COMPLETED
|
8
|
8
|
8
|
10
|
10
|
9
|
|
Part A and B Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part A and B Period 3
STARTED
|
8
|
8
|
8
|
10
|
10
|
9
|
|
Part A and B Period 3
COMPLETED
|
8
|
8
|
8
|
8
|
10
|
8
|
|
Part A and B Period 3
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
1
|
|
Part A and Part B Period 4
STARTED
|
8
|
8
|
8
|
8
|
10
|
8
|
|
Part A and Part B Period 4
COMPLETED
|
8
|
8
|
8
|
6
|
10
|
7
|
|
Part A and Part B Period 4
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
1
|
|
Part A Period 5
STARTED
|
8
|
8
|
8
|
0
|
0
|
0
|
|
Part A Period 5
COMPLETED
|
8
|
8
|
8
|
0
|
0
|
0
|
|
Part A Period 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A: Lispro Sequence 1
Each participant received a single subcutaneous (SC) dose of 7.0 U insulin lispro (Reference) and 4 doses of different test insulin lispro formulations (7.28 U; Tests A, B, C, and D) in one of five periods according to assigned treatment sequence 1, 2, or 3.
Sequence 1: Test A, D, C, Reference, B
|
Part A: Lispro Sequence 2
Each participant received a single SC dose of 7.0 U insulin lispro (Reference) and 4 doses of different test insulin lispro formulations (7.28 U; Tests A, B, C, and D) in one of five periods according to assigned treatment sequence 1, 2, or 3.
Sequence 2: Test B, A, Reference, C, D
|
Part A: Lispro Sequence 3
Each participant received a single SC dose of 7.0 U insulin lispro (Reference) and 4 doses of different test insulin lispro formulations (7.28 U; Tests A, B, C, and D) in one of five periods according to assigned treatment sequence 1, 2, or 3.
Sequence 3: Test Reference, Test C, B, D, A.
|
Part B: Lispro Sequence 1
Each participant received a single dose of lispro SC in one of four periods according to assigned treatment sequence 1, 2, or 3. Participants received test formulation B containing 7.28 U (Units) of insulin lispro given as a single SC injection or test formulation B containing 15.47 U of insulin lispro given as a single SC injection or test formulation B containing 30.03 U of insulin lispro given as a single SC injection.
Sequence 1: 30.03 U, 7.28 U, 15.47 U, 7.28 U
|
Part B Lispro Sequence 2
Each participant received a single dose of lispro SC in one of four periods according to assigned treatment sequence 1, 2, or 3. Participants received test formulation B containing 7.28 U (Units) of insulin lispro given as a single SC injection or test formulation B containing 15.47 U of insulin lispro given as a single SC injection or test formulation B containing 30.03 U of insulin lispro given as a single SC injection.
Sequence 2: 7.28 U, 15.47 U, 30.03 U, 15.47 U
|
Part B Lispro Sequence 3
Each participant received a single dose of lispro SC in one of four periods according to assigned treatment sequence 1, 2, or 3. Participants received test formulation B containing 7.28 U (Units) of insulin lispro given as a single SC injection or test formulation B containing 15.47 U of insulin lispro given as a single SC injection or test formulation B containing 30.03 U of insulin lispro given as a single SC injection.
Sequence 3: 15.47 U, 30.03 U, 7.28 U, 30.03 U
|
|---|---|---|---|---|---|---|
|
Part A and B Period 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part A and B Period 3
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
0
|
1
|
|
Part A and Part B Period 4
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
0
|
1
|
Baseline Characteristics
A Study of Lispro Formulations in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part A Participants
n=24 Participants
Each participant received a single SC dose of 7.0 U insulin lispro (Reference) and 4 doses of different test insulin lispro formulations (7.28 U; Tests A, B, C, and D) in one of five periods according to assigned treatment sequence 1, 2, or 3.
Sequence 1: Test A, D, C, Reference, B Sequence 2: Test B, A, Reference, C, D Sequence 3: Test Reference, Test C, B, D, A.
|
Part B Participants
n=30 Participants
Each participant received a single dose of lispro SC in one of four periods according to assigned treatment sequence 1, 2, or 3. Participants received test formulation B containing 7.28 U (Units) of insulin lispro given as a single SC injection or test formulation B containing 15.47 U of insulin lispro given as a single SC injection or test formulation B containing 30.03 U of insulin lispro given as a single SC injection.
Sequence 1: 30.03 U, 7.28 U, 15.47 U, 7.28 U Sequence 2: 7.28 U, 15.47 U, 30.03 U, 15.47 U Sequence 3: 15.47 U, 30.03 U, 7.28 U, 30.03 U
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 11.5 • n=99 Participants
|
36.8 years
STANDARD_DEVIATION 9.1 • n=107 Participants
|
37.2 years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Singapore
|
24 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: -30, 0 (Predose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, and 300 MinutesPopulation: All randomized participants who were completers and had evaluable PK data.
Primary outcome measure is based on the PK area under the concentration curve from 0 to infinity with a measurable concentration.
Outcome measures
| Measure |
Part A: Lispro (7.0 U - Reference)
n=24 Participants
Reference formulation: Single dose of lispro administered SC in one of five periods.
|
Part A: Lispro (7.28 U - Test A)
n=24 Participants
Formulation A: Single dose of lispro administered SC in one of five periods.
|
Part A: Lispro (7.28 U - Test B)
n=24 Participants
Formulation B: Single dose of lispro administered SC in one of five periods.
|
Part A: Lispro (7.28 U - Test C)
n=24 Participants
Formulation C: Single dose of lispro administered SC in one of five periods.
|
Part A: Lispro (7.28 U - Test D)
n=24 Participants
Formulation D: Single dose of lispro administered SC in one of five periods.
|
Part B: Lispro (7.28 U - Test B)
n=28 Participants
Formulation selected from Part A. Single dose of lispro administered SC in one of four periods.
|
Part B: Lispro (15.47 U - Test B)
n=28 Participants
Formulation selected from Part A. Single dose of lispro administered SC in one of four periods.
|
Part B: Lispro (30.03 U - Test B)
n=29 Participants
Formulation selected from Part A. Single dose of lispro administered SC in one of four periods.
|
|---|---|---|---|---|---|---|---|---|
|
Part A and Part B: Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞])
|
916 picomole*hour/Liter (pmol*hr/L)
Geometric Coefficient of Variation 21
|
957 picomole*hour/Liter (pmol*hr/L)
Geometric Coefficient of Variation 22
|
1020 picomole*hour/Liter (pmol*hr/L)
Geometric Coefficient of Variation 22
|
972 picomole*hour/Liter (pmol*hr/L)
Geometric Coefficient of Variation 21
|
971 picomole*hour/Liter (pmol*hr/L)
Geometric Coefficient of Variation 23
|
864 picomole*hour/Liter (pmol*hr/L)
Geometric Coefficient of Variation 17
|
2000 picomole*hour/Liter (pmol*hr/L)
Geometric Coefficient of Variation 20
|
3990 picomole*hour/Liter (pmol*hr/L)
Geometric Coefficient of Variation 14
|
Adverse Events
Part A: Lispro (7.0 U - Reference)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A: Lispro (7.28 U - Test A)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A: Lispro (7.28 U - Test B)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A: Lispro (7.28 U - Test C)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A: Lispro (7.28 U - Test D)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B: Lispro (7.28 U - Test B)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B: Lispro (15.47 U - Test B)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B: Lispro (30.03 U - Test B)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: Lispro (7.0 U - Reference)
n=24 participants at risk
Reference formulation: Single dose of lispro administered SC in one of five periods.
|
Part A: Lispro (7.28 U - Test A)
n=24 participants at risk
Formulation A: Single dose of lispro administered SC in one of five periods.
|
Part A: Lispro (7.28 U - Test B)
n=24 participants at risk
Formulation B: Single dose of lispro administered SC in one of five periods.
|
Part A: Lispro (7.28 U - Test C)
n=24 participants at risk
Formulation C: Single dose of lispro administered SC in one of five periods.
|
Part A: Lispro (7.28 U - Test D)
n=24 participants at risk
Formulation D: Single dose of lispro administered SC in one of five periods.
|
Part B: Lispro (7.28 U - Test B)
n=28 participants at risk
Formulation selected from Part B. Single dose of lispro administered SC in one of four periods.
|
Part B: Lispro (15.47 U - Test B)
n=28 participants at risk
Formulation selected from Part B. Single dose of lispro administered SC in one of four periods.
|
Part B: Lispro (30.03 U - Test B)
n=29 participants at risk
Formulation selected from Part B. Single dose of lispro administered SC in one of four periods.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
7.1%
2/28 • Number of events 5
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/28
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/29
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
|
General disorders
Catheter site pain
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
4.2%
1/24 • Number of events 1
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/28
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
7.1%
2/28 • Number of events 2
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
6.9%
2/29 • Number of events 2
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
|
General disorders
Catheter site related reaction
|
12.5%
3/24 • Number of events 6
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
8.3%
2/24 • Number of events 3
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
16.7%
4/24 • Number of events 4
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
8.3%
2/24 • Number of events 3
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
17.9%
5/28 • Number of events 5
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
7.1%
2/28 • Number of events 3
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
13.8%
4/29 • Number of events 4
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • Number of events 1
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/28
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/28
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
6.9%
2/29 • Number of events 2
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
8.3%
2/24 • Number of events 2
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/28
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/28
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
3.4%
1/29 • Number of events 1
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
4.2%
1/24 • Number of events 1
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/24
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
8.3%
2/24 • Number of events 2
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
4.2%
1/24 • Number of events 1
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/28
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
0.00%
0/28
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
3.4%
1/29 • Number of events 1
54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
|
Additional Information
Eli Lilly and Company
Chief Medical Officer
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place