Trial Outcomes & Findings for A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM) (NCT NCT03341312)
NCT ID: NCT03341312
Last Updated: 2020-06-09
Results Overview
PK: Insulin Lispro AUC for Each Treatment Arm. PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol .
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes (7 hours) postdose
Results posted on
2020-06-09
Participant Flow
Participant milestones
| Measure |
Cohort 1
Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses
Period 1: LY900014 administered subcutaneously (SC) immediately before meal Period 2: insulin lispro (Humalog) administered SC 20 minutes after start of meal Period 3:LY900014 administered SC 20 minutes after start of meal Period 4: insulin lispro administered SC immediately before meal
|
Cohort 2
Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses
Period 1:LY900014 administered SC 20 minutes after start of meal Period 2: LY900014 administered subcutaneously (SC) immediately before meal Period 3: insulin lispro (Humalog) administered SC immediately before meal Period 4: insulin lispro (Humalog) administered SC 20 minutes after start of meal
|
Cohort 3
Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses
Period 1: insulin lispro (Humalog) administered SC immediately before meal Period 2:LY900014 administered SC 20 minutes after start of meal Period 3: insulin lispro (Humalog) administered SC 20 minutes after start of meal Period 4: LY900014 administered subcutaneously (SC) immediately before meal
|
Cohort 4
Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses
Period 1: insulin lispro (Humalog) administered SC 20 minutes after start of meal Period 2: insulin lispro (Humalog) administered SC immediately before meal Period 3: LY900014 administered subcutaneously (SC) immediately before meal Period 4:LY900014 administered SC 20 minutes after start of meal
|
|---|---|---|---|---|
|
Period 1
STARTED
|
9
|
10
|
9
|
8
|
|
Period 1
Received at Least One Dose of Study Drug
|
9
|
10
|
9
|
8
|
|
Period 1
COMPLETED
|
9
|
9
|
9
|
8
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Period 2
STARTED
|
9
|
9
|
9
|
8
|
|
Period 2
COMPLETED
|
9
|
9
|
9
|
8
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
9
|
9
|
9
|
8
|
|
Period 3
COMPLETED
|
9
|
9
|
9
|
8
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
9
|
9
|
9
|
8
|
|
Period 4
COMPLETED
|
9
|
9
|
9
|
8
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses
Period 1: LY900014 administered subcutaneously (SC) immediately before meal Period 2: insulin lispro (Humalog) administered SC 20 minutes after start of meal Period 3:LY900014 administered SC 20 minutes after start of meal Period 4: insulin lispro administered SC immediately before meal
|
Cohort 2
Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses
Period 1:LY900014 administered SC 20 minutes after start of meal Period 2: LY900014 administered subcutaneously (SC) immediately before meal Period 3: insulin lispro (Humalog) administered SC immediately before meal Period 4: insulin lispro (Humalog) administered SC 20 minutes after start of meal
|
Cohort 3
Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses
Period 1: insulin lispro (Humalog) administered SC immediately before meal Period 2:LY900014 administered SC 20 minutes after start of meal Period 3: insulin lispro (Humalog) administered SC 20 minutes after start of meal Period 4: LY900014 administered subcutaneously (SC) immediately before meal
|
Cohort 4
Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses
Period 1: insulin lispro (Humalog) administered SC 20 minutes after start of meal Period 2: insulin lispro (Humalog) administered SC immediately before meal Period 3: LY900014 administered subcutaneously (SC) immediately before meal Period 4:LY900014 administered SC 20 minutes after start of meal
|
|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)
Baseline characteristics by cohort
| Measure |
Overall Study
n=36 Participants
All randomized participants who received at least 1 dose of study drug.
|
|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
36 Participants
n=5 Participants
|
|
Duration of T2DM
|
16.704 years
STANDARD_DEVIATION 8.957 • n=5 Participants
|
PRIMARY outcome
Timeframe: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes (7 hours) postdosePopulation: All randomized participants who received at least 1 dose of study drug and evaluable PK data. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol .
PK: Insulin Lispro AUC for Each Treatment Arm. PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol .
Outcome measures
| Measure |
LY900014
n=35 Participants
All participants who received individualized dose of LY900014 SC before meal or 20 minutes after start of meal
|
Insulin Lispro (Humalog)
n=35 Participants
All participants who received individualized dose of insulin lispro (Humalog) SC before meal or 20 minutes after start of meal
|
Insulin Lispro (Humalog) Before Meal
Individualized dose of insulin lispro (Humalog)administered SC immediately before meal in one of four study periods.
|
Insulin Lispro (Humalog) After Meal
Individualized dose of insulin lispro (Humalog) administered SC 20 minutes after start of meal in one of four study periods.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to Seven Hours (AUC0-7hr)
|
1320 picomol times hour per Liter
Geometric Coefficient of Variation 63
|
1240 picomol times hour per Liter
Geometric Coefficient of Variation 68
|
—
|
—
|
SECONDARY outcome
Timeframe: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes post-mealPopulation: All randomized participants who received at least 1 dose of study drug and had evaluable glucodynamic parameters.
GD: Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm
Outcome measures
| Measure |
LY900014
n=35 Participants
All participants who received individualized dose of LY900014 SC before meal or 20 minutes after start of meal
|
Insulin Lispro (Humalog)
n=35 Participants
All participants who received individualized dose of insulin lispro (Humalog) SC before meal or 20 minutes after start of meal
|
Insulin Lispro (Humalog) Before Meal
n=35 Participants
Individualized dose of insulin lispro (Humalog)administered SC immediately before meal in one of four study periods.
|
Insulin Lispro (Humalog) After Meal
n=35 Participants
Individualized dose of insulin lispro (Humalog) administered SC 20 minutes after start of meal in one of four study periods.
|
|---|---|---|---|---|
|
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm
|
97.8 milligrams times hour per deciliter
Standard Deviation 155
|
112 milligrams times hour per deciliter
Standard Deviation 139
|
131 milligrams times hour per deciliter
Standard Deviation 155
|
146 milligrams times hour per deciliter
Standard Deviation 150
|
Adverse Events
LY900014 Before Meal
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LY900014 After Meal
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Insulin Lispro (Humalog) Before Meal
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Insulin Lispro (Humalog) After Meal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY900014 Before Meal
n=35 participants at risk
Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods.
|
LY900014 After Meal
n=36 participants at risk
Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods.
|
Insulin Lispro (Humalog) Before Meal
n=35 participants at risk
Individualized dose of insulin lispro (Humalog) administered SC immediately before meal in one of four study periods.
|
Insulin Lispro (Humalog) After Meal
n=35 participants at risk
Individualized dose of insulin lispro (Humalog) administered SC 20 minutes after start of meal in one of four study periods.
|
|---|---|---|---|---|
|
General disorders
Injection site reaction
|
2.9%
1/35 • Number of events 1 • 4 weeks
All participants who received at least one dose of study drug.
|
5.6%
2/36 • Number of events 2 • 4 weeks
All participants who received at least one dose of study drug.
|
2.9%
1/35 • Number of events 1 • 4 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/35 • 4 weeks
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60