Trial Outcomes & Findings for A Study of LY900014 in Elderly and Younger Adult Participants With Type 1 Diabetes Mellitus (NCT NCT03166124)
NCT ID: NCT03166124
Last Updated: 2020-04-30
Results Overview
Pharmacokinetics: Insulin lispro AUC from time zero to 10 hours postdose \[AUC(0-10h)\] for each treatment arm.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
80 participants
Primary outcome timeframe
Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose
Results posted on
2020-04-30
Participant Flow
This is a 2-period, crossover study, up to 10-hour euglycemic clamp in which participants were randomized to 1 of 2 treatment sequences: LY900014 in Period 1 switching to Humalog period 2 or Humalog in Period 1 switching to LY900014 in Period 2. A washout period of 3 to 15 days occurred between study drug administration.
Participant milestones
| Measure |
Sequence 1 AB Elderly Adults
Sequence 1:
A: Single, subcutaneous (SC) 15-U dose of LY900014 in Period 1. B: Single, SC 15-U dose of Humalog in Period 2. Washout period of 3-15 days between study drug administration.
|
Sequence 1 AB Younger Adults
Sequence 1 A: Single, SC 15-U dose of LY900014 in Period 1. B: single, SC 15-U dose of Humalog in Period 2. Washout 3-15 days between study drug administration.
|
Sequence 2 BA Elderly Adults
Sequence 2:
B: Single, SC 15-U dose of Humalog in Period 1. A: Single, SC 15-U dose of LY900014 in Period 2. A Washout period of 3-15 days between study drug administration.
|
Sequence 2 BA Younger Adults
Sequence 2:
B: Single, SC 15-U dose of Humalog in Period 1. A: Single SC 15-U dose of LY900014 in Period 2. A Washout period of 3-15 days between study drug administration.
|
|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
20
|
20
|
19
|
21
|
|
Treatment Period 1
Received at Least One Dose of Study Drug
|
20
|
20
|
18
|
21
|
|
Treatment Period 1
COMPLETED
|
20
|
20
|
18
|
21
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Wash-out Period
STARTED
|
20
|
20
|
18
|
21
|
|
Wash-out Period
COMPLETED
|
20
|
18
|
17
|
20
|
|
Wash-out Period
NOT COMPLETED
|
0
|
2
|
1
|
1
|
|
Treatment Period 2
STARTED
|
20
|
18
|
17
|
20
|
|
Treatment Period 2
COMPLETED
|
20
|
18
|
17
|
20
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1 AB Elderly Adults
Sequence 1:
A: Single, subcutaneous (SC) 15-U dose of LY900014 in Period 1. B: Single, SC 15-U dose of Humalog in Period 2. Washout period of 3-15 days between study drug administration.
|
Sequence 1 AB Younger Adults
Sequence 1 A: Single, SC 15-U dose of LY900014 in Period 1. B: single, SC 15-U dose of Humalog in Period 2. Washout 3-15 days between study drug administration.
|
Sequence 2 BA Elderly Adults
Sequence 2:
B: Single, SC 15-U dose of Humalog in Period 1. A: Single, SC 15-U dose of LY900014 in Period 2. A Washout period of 3-15 days between study drug administration.
|
Sequence 2 BA Younger Adults
Sequence 2:
B: Single, SC 15-U dose of Humalog in Period 1. A: Single SC 15-U dose of LY900014 in Period 2. A Washout period of 3-15 days between study drug administration.
|
|---|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
0
|
0
|
1
|
0
|
|
Wash-out Period
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
|
Wash-out Period
Adverse Event
|
0
|
1
|
1
|
0
|
Baseline Characteristics
A Study of LY900014 in Elderly and Younger Adult Participants With Type 1 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Elderly Adults
n=39 Participants
Male and female participants age 65 or older inclusive.
|
Younger Adults
n=41 Participants
Male and female participants age 18 to 45 inclusive.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
32.0 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
49.8 years
STANDARD_DEVIATION 19.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
80 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
|
39 Participants
n=5 Participants
|
41 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
|
39 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Weight
|
76.66 kilograms (kg)
STANDARD_DEVIATION 12.61 • n=5 Participants
|
78.39 kilograms (kg)
STANDARD_DEVIATION 10.00 • n=7 Participants
|
77.55 kilograms (kg)
STANDARD_DEVIATION 11.41 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes post-dosePopulation: All participants who received at least one dose of study drug and have measurable insulin lispro concentrations.
Pharmacokinetics: Insulin lispro AUC from time zero to 10 hours postdose \[AUC(0-10h)\] for each treatment arm.
Outcome measures
| Measure |
Elderly Adults LY900014
n=37 Participants
All elderly adults who received a single 15-U SC dose LY900014.
|
Elderly Adults Humalog
n=37 Participants
All elderly adults who received a single 15-U SC dose Humalog.
|
Younger Adults LY900014
n=40 Participants
All younger adults who received a single 15-U SC dose LY900014.
|
Younger Adults Humalog
n=39 Participants
All younger adults who received single 15-U SC dose Humalog.
|
|---|---|---|---|---|
|
Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) for Each Treatment Arm
|
1430 picomole * hour per Liter (pmol*h/L)
Geometric Coefficient of Variation 26
|
1400 picomole * hour per Liter (pmol*h/L)
Geometric Coefficient of Variation 29
|
1210 picomole * hour per Liter (pmol*h/L)
Geometric Coefficient of Variation 24
|
1170 picomole * hour per Liter (pmol*h/L)
Geometric Coefficient of Variation 30
|
SECONDARY outcome
Timeframe: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dosePopulation: All participants who received at least one dose of study drug and completed at least one clamp procedure.
Glucodynamics: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure.
Outcome measures
| Measure |
Elderly Adults LY900014
n=37 Participants
All elderly adults who received a single 15-U SC dose LY900014.
|
Elderly Adults Humalog
n=35 Participants
All elderly adults who received a single 15-U SC dose Humalog.
|
Younger Adults LY900014
n=40 Participants
All younger adults who received a single 15-U SC dose LY900014.
|
Younger Adults Humalog
n=39 Participants
All younger adults who received single 15-U SC dose Humalog.
|
|---|---|---|---|---|
|
Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm
|
1140 milligram per kilogram (mg/kg)
Geometric Coefficient of Variation 42
|
1090 milligram per kilogram (mg/kg)
Geometric Coefficient of Variation 43
|
1170 milligram per kilogram (mg/kg)
Geometric Coefficient of Variation 33
|
1150 milligram per kilogram (mg/kg)
Geometric Coefficient of Variation 30
|
Adverse Events
Elderly Adults LY900014
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Elderly Adults Humalog
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Younger Adults LY900014
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Younger Adults Humalog
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Elderly Adults LY900014
n=37 participants at risk
Single, subcutaneous (SC) 15-U dose of LY900014.
|
Elderly Adults Humalog
n=38 participants at risk
Single, SC 15-U dose of Humalog.
|
Younger Adults LY900014
n=40 participants at risk
Single, SC 15-U dose of LY900014.
|
Younger Adults Humalog
n=39 participants at risk
Single, SC 15-U dose of Humalog.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/37 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
0.00%
0/38 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
0.00%
0/39 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Elderly Adults LY900014
n=37 participants at risk
Single, subcutaneous (SC) 15-U dose of LY900014.
|
Elderly Adults Humalog
n=38 participants at risk
Single, SC 15-U dose of Humalog.
|
Younger Adults LY900014
n=40 participants at risk
Single, SC 15-U dose of LY900014.
|
Younger Adults Humalog
n=39 participants at risk
Single, SC 15-U dose of Humalog.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.7%
1/37 • Number of events 1 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
5.3%
2/38 • Number of events 2 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
10.3%
4/39 • Number of events 4 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
3/37 • Number of events 4 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
13.2%
5/38 • Number of events 5 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 3 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
10.3%
4/39 • Number of events 4 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
2/37 • Number of events 2 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
0.00%
0/38 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
2.7%
1/37 • Number of events 1 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
10.5%
4/38 • Number of events 4 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
|
7.7%
3/39 • Number of events 3 • Baseline to end of study (up to 39 days)
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