Trial Outcomes & Findings for A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps (NCT NCT04276207)
NCT ID: NCT04276207
Last Updated: 2021-08-25
Results Overview
Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 Milligrams per deciliter (mg/dL).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Day 1: Baseline up to 5 hours after missed meal bolus
Results posted on
2021-08-25
Participant Flow
Participant milestones
| Measure |
Sequence AB (LY900014, Insulin Lispro (Humalog))
Period 1:
Participants received 100 units per milliliter (U/mL) of LY900014 administered by continuous subcutaneous insulin infusion (CSII).
Period 2:
Participants received 100 U/mL of Insulin lispro Humalog) administered by CSII.
|
Sequence BA (Insulin Lispro (Humalog), LY900014))
Period 1:
Participants received 100 U/mL of Insulin lispro (Humalog) administered by CSII.
Period 2:
Participants received 100 U/mL of LY900014 administered by CSII.
|
|---|---|---|
|
Period 1
STARTED
|
15
|
17
|
|
Period 1
Received at Least One Dose of Study Drug
|
15
|
17
|
|
Period 1
COMPLETED
|
15
|
16
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
|
Washout (3- 14 Days)
STARTED
|
15
|
16
|
|
Washout (3- 14 Days)
COMPLETED
|
15
|
16
|
|
Washout (3- 14 Days)
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
15
|
16
|
|
Period 2
COMPLETED
|
15
|
16
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence AB (LY900014, Insulin Lispro (Humalog))
Period 1:
Participants received 100 units per milliliter (U/mL) of LY900014 administered by continuous subcutaneous insulin infusion (CSII).
Period 2:
Participants received 100 U/mL of Insulin lispro Humalog) administered by CSII.
|
Sequence BA (Insulin Lispro (Humalog), LY900014))
Period 1:
Participants received 100 U/mL of Insulin lispro (Humalog) administered by CSII.
Period 2:
Participants received 100 U/mL of LY900014 administered by CSII.
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps
Baseline characteristics by cohort
| Measure |
100 U/mL LY900014 and 100 U/mL Insulin Lispro (Humalog)
n=32 Participants
Participants received 100 U/mL LY900014 administered by CSII in one of two study periods.
Participants received 100 U/mL Insulin Lispro (Humalog) administered by CSII in one of two study periods.
|
|---|---|
|
Age, Continuous
|
33.8 years
STANDARD_DEVIATION 9.57 • n=93 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
32 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Day 1: Baseline up to 5 hours after missed meal bolusPopulation: All participants who received both study treatments with the same insulin dose and achieved recovery from hyperglycemia on day 1
Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 Milligrams per deciliter (mg/dL).
Outcome measures
| Measure |
100 U/mL LY900014
n=21 Participants
Participants received 100 U/mL of LY900014 administered by CSII in one of the two study periods.
|
100 U/mL Insulin Lispro (Humalog)
n=21 Participants
Participants received 100 U/mL of Insulin lispro (Humalog) administered by CSII in one of the two study periods.
|
|---|---|---|
|
Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Missed Meal Bolus
|
1.79 Hours
Interval 0.85 to 4.25
|
2.55 Hours
Interval 0.92 to 4.68
|
PRIMARY outcome
Timeframe: Day 2: Baseline up to 5 hours after pump suspensionPopulation: All participants who received both study treatments with the same insulin dose and achieved recovery from hyperglycemia on day 2
Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 mg/dL.
Outcome measures
| Measure |
100 U/mL LY900014
n=28 Participants
Participants received 100 U/mL of LY900014 administered by CSII in one of the two study periods.
|
100 U/mL Insulin Lispro (Humalog)
n=28 Participants
Participants received 100 U/mL of Insulin lispro (Humalog) administered by CSII in one of the two study periods.
|
|---|---|---|
|
Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Pump Suspension
|
1.53 Hours
Interval 0.97 to 2.24
|
1.78 Hours
Interval 1.33 to 2.44
|
SECONDARY outcome
Timeframe: Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspensionPopulation: All participants who received both study treatments with the same insulin dose and achieved recovery from hyperglycemia on days 1 and 2
PD: PGmax following administration of LY900014 and insulin lispro (Humalog)
Outcome measures
| Measure |
100 U/mL LY900014
n=28 Participants
Participants received 100 U/mL of LY900014 administered by CSII in one of the two study periods.
|
100 U/mL Insulin Lispro (Humalog)
n=28 Participants
Participants received 100 U/mL of Insulin lispro (Humalog) administered by CSII in one of the two study periods.
|
|---|---|---|
|
Pharmacodynamics (PD): Maximum Observed Plasma Glucose (PGmax) Following Administration of LY900014 and Insulin Lispro (Humalog)
Day 1
|
297 Milligrams per deciliter (mg/dL)
Standard Deviation 27.6
|
309 Milligrams per deciliter (mg/dL)
Standard Deviation 24.9
|
|
Pharmacodynamics (PD): Maximum Observed Plasma Glucose (PGmax) Following Administration of LY900014 and Insulin Lispro (Humalog)
Day 2
|
259 Milligrams per deciliter (mg/dL)
Standard Deviation 11.1
|
265 Milligrams per deciliter (mg/dL)
Standard Deviation 9.26
|
SECONDARY outcome
Timeframe: Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspensionPopulation: All participants who received both study treatments with the same insulin dose and achieved recovery from hyperglycemia on days 1 and 2
PK: Tmax following administration of LY900014 and insulin lispro (Humalog)
Outcome measures
| Measure |
100 U/mL LY900014
n=28 Participants
Participants received 100 U/mL of LY900014 administered by CSII in one of the two study periods.
|
100 U/mL Insulin Lispro (Humalog)
n=28 Participants
Participants received 100 U/mL of Insulin lispro (Humalog) administered by CSII in one of the two study periods.
|
|---|---|---|
|
Pharmacokinetics (PK): Time to Maximum Observed Insulin Lispro Concentration (Tmax) Following Administration of LY900014 and Insulin Lispro (Humalog)
Day 1
|
0.75 Hours
Interval 0.33 to 1.75
|
0.83 Hours
Interval 0.33 to 1.75
|
|
Pharmacokinetics (PK): Time to Maximum Observed Insulin Lispro Concentration (Tmax) Following Administration of LY900014 and Insulin Lispro (Humalog)
Day 2
|
0.92 Hours
Interval 0.25 to 2.25
|
0.92 Hours
Interval 0.5 to 2.5
|
Adverse Events
100 U/mL LY900014
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
100 U/mL Insulin Lispro (Humalog)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
100 U/mL LY900014
n=31 participants at risk
Participants received 100 U/mL of LY900014 administered by CSII in one of the two study periods.
|
100 U/mL Insulin Lispro (Humalog)
n=32 participants at risk
Participants received 100 U/mL of Insulin lispro (Humalog) administered by CSII in one of the two study periods.
|
|---|---|---|
|
Endocrine disorders
Hyperglycaemia
|
6.5%
2/31 • Number of events 2 • Baseline Up To 42 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/32 • Baseline Up To 42 Days
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
6.5%
2/31 • Number of events 2 • Baseline Up To 42 Days
All randomized participants who received at least one dose of study drug.
|
6.2%
2/32 • Number of events 2 • Baseline Up To 42 Days
All randomized 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