Trial Outcomes & Findings for A Study of LY900014 Formulation in Participants With Type 1 Diabetes Mellitus Using Insulin Pumps (NCT NCT02703324)
NCT ID: NCT02703324
Last Updated: 2020-06-17
Results Overview
PK: Insulin Lispro AUC(0-5h)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Days 1 and 3: -15, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300 minutes post dose for each treatment
Results posted on
2020-06-17
Participant Flow
This study compared individualized doses of LY900014 (Test) to insulin lispro (Reference) when delivered via an insulin pump. The study consisted of four, three-day treatment periods, with a maximum of one week between doses in consecutive periods.
Participant milestones
| Measure |
Sequence 1, TRTR
T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous subcutaneous (SC) infusion with intermittent bolus doses immediately before meals for three days.
|
Sequence 2, RTRT
T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days.
|
Sequence 3, TTRR
T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days.
|
Sequence 4, RRTT
T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days.
|
Sequence 5, TRRT
T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days.
|
Sequence 6, RTTR
T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days.
|
|---|---|---|---|---|---|---|
|
Period One
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Period One
Received Study Drug
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Period One
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Period One
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period Two
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Period Two
Received Study Drug
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Period Two
COMPLETED
|
5
|
5
|
4
|
5
|
5
|
5
|
|
Period Two
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Period Three
STARTED
|
5
|
5
|
4
|
5
|
5
|
5
|
|
Period Three
Received Study Drug
|
5
|
5
|
4
|
5
|
5
|
5
|
|
Period Three
COMPLETED
|
5
|
5
|
4
|
5
|
5
|
5
|
|
Period Three
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period Four
STARTED
|
5
|
4
|
4
|
5
|
5
|
5
|
|
Period Four
Received Study Drug
|
5
|
4
|
4
|
5
|
5
|
5
|
|
Period Four
COMPLETED
|
5
|
4
|
4
|
5
|
5
|
5
|
|
Period Four
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1, TRTR
T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous subcutaneous (SC) infusion with intermittent bolus doses immediately before meals for three days.
|
Sequence 2, RTRT
T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days.
|
Sequence 3, TTRR
T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days.
|
Sequence 4, RRTT
T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days.
|
Sequence 5, TRRT
T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days.
|
Sequence 6, RTTR
T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days.
|
|---|---|---|---|---|---|---|
|
Period Two
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY900014 Formulation in Participants With Type 1 Diabetes Mellitus Using Insulin Pumps
Baseline characteristics by cohort
| Measure |
All Participants
n=30 Participants
Individualized doses of LY900014 (Test) or insulin lispro (Reference) delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals in four, three-day periods.
|
|---|---|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 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
|
30 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
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1 and 3: -15, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300 minutes post dose for each treatmentPopulation: All participants who received both study drugs and had evaluable PK data. For one participant in the Insulin Lispro - Reference group, the insulin lispro PK profile (Period Two, Day 3) was excluded from the mean PK analysis, as there was no absorption phase observed.
PK: Insulin Lispro AUC(0-5h)
Outcome measures
| Measure |
Insulin Lispro - Reference
n=29 Participants
Individualized doses of insulin lispro delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses during meals for two 3-day periods.
|
LY900014 - Test
n=29 Participants
Individualized doses of LY900014 delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses during meals for two 3-day periods.
|
|---|---|---|
|
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h])
Day 3
|
906 picomole*hour per liter (pmol•h/L)
Geometric Coefficient of Variation 30
|
824 picomole*hour per liter (pmol•h/L)
Geometric Coefficient of Variation 37
|
|
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h])
Day 1
|
918 picomole*hour per liter (pmol•h/L)
Geometric Coefficient of Variation 26
|
970 picomole*hour per liter (pmol•h/L)
Geometric Coefficient of Variation 28
|
SECONDARY outcome
Timeframe: Days 1 and 3: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes post dose for each treatmentPopulation: All participants who received study drug and had evaluable PD data.
PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)
Outcome measures
| Measure |
Insulin Lispro - Reference
n=29 Participants
Individualized doses of insulin lispro delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses during meals for two 3-day periods.
|
LY900014 - Test
n=29 Participants
Individualized doses of LY900014 delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses during meals for two 3-day periods.
|
|---|---|---|
|
Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)
Day 1
|
584 milligram*hour/deciliter (mg*h/dL)
Standard Deviation 175
|
567 milligram*hour/deciliter (mg*h/dL)
Standard Deviation 172
|
|
Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)
Day 3
|
551 milligram*hour/deciliter (mg*h/dL)
Standard Deviation 185
|
628 milligram*hour/deciliter (mg*h/dL)
Standard Deviation 210
|
Adverse Events
Insulin Lispro - Reference
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
LY900014 - Test
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Insulin Lispro - Open Label
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 |
Insulin Lispro - Reference
n=29 participants at risk
Individualized doses of insulin lispro delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses during meals for two three-day periods.
|
LY900014 - Test
n=30 participants at risk
Individualized doses of LY900014 delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses during meals for two three-day periods.
|
Insulin Lispro - Open Label
n=30 participants at risk
Individualized doses of open label insulin lispro delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses between periods.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
13.8%
4/29 • Number of events 4
|
10.0%
3/30 • Number of events 4
|
0.00%
0/30
|
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
Restriction type: GT60