Trial Outcomes & Findings for A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus (NCT NCT03449433)
NCT ID: NCT03449433
Last Updated: 2020-04-30
Results Overview
PK: Insulin Lispro or Insulin Aspart AUC(0-7h)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
80 participants
Primary outcome timeframe
0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 70, 90, 120, 150,180, 240, 300, 360 and 420 minutes postdose
Results posted on
2020-04-30
Participant Flow
Participant milestones
| Measure |
Type 1 Diabetes Mellitus (T1DM) Cohort 1
Period 1: LY900014 administered subcutaneously (SC) immediately before meal Period 2: insulin n Aspart (Fiasp®) administered SC Period 3:Insulin Lispro (Humalog®) administered SC Period 4: Insulin Aspart (NovoRapid®) administered SC
with 21 hours between doses
|
T1DM Cohort 2
Period 1: Insulin Aspart (Fiasp®) administered SC Period 2: LY900014 administered subcutaneously (SC) Period 3: Insulin Aspart (NovoRapid®) administered SC Period 4:Insulin Lispro (Humalog®) administered SC
with 21 hours between doses
|
T1DM Cohort 3
Period 1: Insulin Aspart (NovoRapid®) administered SC Period 2:Insulin Lispro (Humalog®) administered SC Period 3: insulin Aspart (Fiasp®) administered SC Period 4: LY900014 administered subcutaneously (SC)
with 21 hours between doses
|
T1DM Cohort 4
Period 1:Insulin Lispro (Humalog®) administered SC Period 2: Insulin Aspart (NovoRapid®) administered SC Period 3: LY900014 administered SC Period 4: insulin Aspart (Fiasp®) administered SC
with 21 hours between doses
|
Healthy Participants
Healthy participant cohort did not receive any dose of study drug.
|
|---|---|---|---|---|---|
|
Period 1
STARTED
|
17
|
16
|
18
|
17
|
12
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
17
|
16
|
18
|
17
|
0
|
|
Period 1
COMPLETED
|
17
|
16
|
18
|
17
|
12
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
17
|
16
|
18
|
17
|
12
|
|
Period 2
Received at Least 1 Dose of Study Drug
|
17
|
16
|
18
|
17
|
0
|
|
Period 2
COMPLETED
|
17
|
16
|
18
|
17
|
12
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
17
|
16
|
18
|
17
|
12
|
|
Period 3
Received at Least 1 Dose of Study Drug
|
17
|
15
|
18
|
17
|
0
|
|
Period 3
COMPLETED
|
17
|
15
|
18
|
17
|
12
|
|
Period 3
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
|
Period 4
STARTED
|
17
|
15
|
18
|
17
|
12
|
|
Period 4
Received at Least 1 Dose of Study Drug
|
17
|
15
|
18
|
17
|
0
|
|
Period 4
COMPLETED
|
17
|
15
|
18
|
17
|
12
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
T1DM Cohort
n=68 Participants
All randomized participants with T1DM participants who received at least 1 dose of study drug.
|
Healthy Participants
n=12 Participants
All healthy participants.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
79 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
68 participants
n=5 Participants
|
12 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
25.82 kilograms per meter squared
STANDARD_DEVIATION 2.36 • n=5 Participants
|
25.38 kilograms per meter squared
STANDARD_DEVIATION 1.80 • n=7 Participants
|
25.38 kilograms per meter squared
STANDARD_DEVIATION 1.80 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 70, 90, 120, 150,180, 240, 300, 360 and 420 minutes postdosePopulation: All randomized, T1DM participants who received at least 1 dose of study drug.
PK: Insulin Lispro or Insulin Aspart AUC(0-7h)
Outcome measures
| Measure |
LY900014
n=62 Participants
T1DM participants received a single, individualized, subcutaneous (SC) dose of LY900014
|
Insulin Lispro (Humalog®)
n=62 Participants
T1DM participants received a single,individualized, SC dose of insulin lispro (Humalog)
|
Insulin Aspart (NovoRapid®)
n=62 Participants
T1DM participants received a single,individualized, SC dose of insulin
|
Insulin Aspart (Fiasp®)
n=62 Participants
T1DM participants received a single,individualized, SC dose of insulin aspart
|
Healthy Participants
Healthy participants, cohort did not receive study drug.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm
|
786 picomols times hour per Liter
Geometric Coefficient of Variation 36
|
756 picomols times hour per Liter
Geometric Coefficient of Variation 37
|
938 picomols times hour per Liter
Geometric Coefficient of Variation 41
|
928 picomols times hour per Liter
Geometric Coefficient of Variation 36
|
—
|
SECONDARY outcome
Timeframe: Time Frame:-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes postdosePopulation: All randomized participants who evaluable PD parameters.
PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)
Outcome measures
| Measure |
LY900014
n=67 Participants
T1DM participants received a single, individualized, subcutaneous (SC) dose of LY900014
|
Insulin Lispro (Humalog®)
n=67 Participants
T1DM participants received a single,individualized, SC dose of insulin lispro (Humalog)
|
Insulin Aspart (NovoRapid®)
n=67 Participants
T1DM participants received a single,individualized, SC dose of insulin
|
Insulin Aspart (Fiasp®)
n=67 Participants
T1DM participants received a single,individualized, SC dose of insulin aspart
|
Healthy Participants
n=12 Participants
Healthy participants, cohort did not receive study drug.
|
|---|---|---|---|---|---|
|
Pharmacodynamics (PD): Change From Baseline Area Under the Concentration Curve of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)
|
81.5 milligrams times hour per deciliter
Standard Deviation 212
|
141 milligrams times hour per deciliter
Standard Deviation 224
|
157 milligrams times hour per deciliter
Standard Deviation 243
|
101 milligrams times hour per deciliter
Standard Deviation 226
|
44.1 milligrams times hour per deciliter
Standard Deviation 32.5
|
Adverse Events
LY900014
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Insulin Lispro (Humalog®)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Insulin Aspart (Fiasp®)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Insulin Aspart (NovoRapid®)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60