Trial Outcomes & Findings for A Study of LY900014 Administered in Participants With Type 1 Diabetes Using an Insulin Pump (NCT NCT03056456)
NCT ID: NCT03056456
Last Updated: 2020-05-01
Results Overview
PK: Insulin Lispro AUC(0-5h)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 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, and 300 minutes post dose
Results posted on
2020-05-01
Participant Flow
For the time between consecutive periods, participants continued their CSII with their personal pump using Insulin lispro (Humalog) until the evening of Day -1 (after administration of the standardized dinner) of the next period when they will receive either LY900014 or Insulin lispro (Humalog), according to assigned treatment.
Participants were randomized to receive LY900014 and Insulin lispro (Humalog) via CSII with intermittent bolus doses, standard single-wave (SS) and standard dual-wave (SD) immediately before meals, over 3 days per period.
Participant milestones
| Measure |
Sequence 1
Administration modes for LY900014 or Insulin lispro (Humalog) for Days 1 through 3 for breakfast (B):
Period 1: Insulin lispro (Humalog)
Day 1: B: SD Day 3: B: SD
Period 2: Insulin lispro (Humalog)
Day 1: B: SS Day 3: B: SS
Period 3: LY900014
Day 1: B: SD Day 3: B: SD
Period 4: LY900014
Day 1: B: SS Day 3: B: SS
|
Sequence 2
Administration modes for LY900014 or Insulin lispro (Humalog) for Days 1 through 3 for breakfast:
Period 1:Insulin lispro (Humalog)
Day 1: B: SS Day 3: B: SS
Period 2: LY900014
Day 1: B: SS Day 3: B: SS
Period 3: Insulin lispro (Humalog)
Day 1: B: SD Day 3: B: SD
Period 4: LY900014
Day 1: B: SD Day 3: B: SD
|
Sequence 3
Administration modes for LY900014 or Insulin lispro (Humalog) for Days 1 through 3 for breakfast:
Period 1: LY900014
Day 1: B: SD Day 3: B: SD
Period 2: Insulin lispro (Humalog)
Day 1: B: SD Day 3: B: SD
Period 3: LY900014
Day 1: B: SS Day 3: B: SS
Period 4: Insulin lispro (Humalog)
Day 1: B: SS Day 3: B: SS
|
Sequence 4
Administration modes for LY900014 or Insulin lispro (Humalog) for Days 1 through 3 for breakfast:
Period 1:LY900014
Day 1: B: SS Day 3: B: SS
Period 2: LY900014
Day 1: B: SD Day 3: B: SD
Period 3: Insulin lispro (Humalog)
Day 1: B: SS Day 3: B: SS
Period 4: Insulin lispro (Humalog)
Day 1: B: SD Day 3: B: SD
|
|---|---|---|---|---|
|
Period 1
STARTED
|
6
|
6
|
6
|
6
|
|
Period 1
Received One Dose of Study Drug
|
6
|
6
|
6
|
6
|
|
Period 1
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
6
|
6
|
6
|
6
|
|
Period 2
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
6
|
6
|
6
|
6
|
|
Period 3
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
6
|
6
|
6
|
5
|
|
Period 4
COMPLETED
|
6
|
6
|
6
|
5
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY900014 Administered in Participants With Type 1 Diabetes Using an Insulin Pump
Baseline characteristics by cohort
| Measure |
Overall Baseline
n=24 Participants
Participants received individualized doses of LY900014 and Insulin lispro (Humalog) via CSII with various intermittent bolus doses immediately before meals, over 3 days per period.
|
|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 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
|
24 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
|
24 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, and 300 minutes post dosePopulation: All participants who received at least one dose of both study drugs and had evaluable PK data during the breakfast test meal.
PK: Insulin Lispro AUC(0-5h)
Outcome measures
| Measure |
LY900014 SS
n=24 Participants
Individualized doses of LY900014 delivered via CSII with intermitted bolus dose administered as standard single-wave bolus on Day 1 and 3.
|
Insulin Lispro (Humalog) SS
n=24 Participants
Individualized doses of Insulin lispro (Humalog) delivered via CSII with intermittent bolus dose administered as a standard single-wave bolus on Day 1 and 3.
|
|---|---|---|
|
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours(h) (AUC [0-5 h]) Following Administration of Each Study Arm With a Standard Single-wave Bolus
Day 1
|
1040 picomole x hour per liter (pmol*h/L)
Geometric Coefficient of Variation 42
|
1040 picomole x hour per liter (pmol*h/L)
Geometric Coefficient of Variation 43
|
|
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours(h) (AUC [0-5 h]) Following Administration of Each Study Arm With a Standard Single-wave Bolus
Day 3
|
1050 picomole x hour per liter (pmol*h/L)
Geometric Coefficient of Variation 47
|
1040 picomole x hour per liter (pmol*h/L)
Geometric Coefficient of Variation 48
|
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, and 300 minutes post dosePopulation: All participants who received both study drugs and had evaluable PK during the breakfast test meal.
PK: Insulin Lispro AUC(0-5h)
Outcome measures
| Measure |
LY900014 SS
n=22 Participants
Individualized doses of LY900014 delivered via CSII with intermitted bolus dose administered as standard single-wave bolus on Day 1 and 3.
|
Insulin Lispro (Humalog) SS
n=22 Participants
Individualized doses of Insulin lispro (Humalog) delivered via CSII with intermittent bolus dose administered as a standard single-wave bolus on Day 1 and 3.
|
|---|---|---|
|
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5 h]) of Following Administration of Each Study Arm With a Standard Dual-wave Bolus
Day 1
|
985 pmol*h/L
Geometric Coefficient of Variation 48
|
956 pmol*h/L
Geometric Coefficient of Variation 46
|
|
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5 h]) of Following Administration of Each Study Arm With a Standard Dual-wave Bolus
Day 3
|
1010 pmol*h/L
Geometric Coefficient of Variation 53
|
969 pmol*h/L
Geometric Coefficient of Variation 48
|
SECONDARY outcome
Timeframe: Days 1 and 3: -30, -15, 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180,195, 210, 225, 240, and 300 minutes post dosePopulation: All participants who received at least one dose of both study drugs and had evaluable GD during the breakfast test meal. Last observation carried forward (LOCF) was used for last observed glucose values prior to treatment intervention for hypoglycemic or hyperglycemic events.
GD: Change from baseline in AUC (0-5h) of glucose relative to mixed meal tolerance test (MMTT).
Outcome measures
| Measure |
LY900014 SS
n=24 Participants
Individualized doses of LY900014 delivered via CSII with intermitted bolus dose administered as standard single-wave bolus on Day 1 and 3.
|
Insulin Lispro (Humalog) SS
n=24 Participants
Individualized doses of Insulin lispro (Humalog) delivered via CSII with intermittent bolus dose administered as a standard single-wave bolus on Day 1 and 3.
|
|---|---|---|
|
Glucodynamics (GD): Change From Baseline Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5h]) of Glucose Relative to Mixed Meal Tolerance Test Following Administration of Each Study Arm With a Standard Single-wave Bolus
Day 1
|
16.8 milligrams * hour/deciliter (mg*h/dL)
Standard Deviation 182
|
38.9 milligrams * hour/deciliter (mg*h/dL)
Standard Deviation 186
|
|
Glucodynamics (GD): Change From Baseline Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5h]) of Glucose Relative to Mixed Meal Tolerance Test Following Administration of Each Study Arm With a Standard Single-wave Bolus
Day 3
|
140 milligrams * hour/deciliter (mg*h/dL)
Standard Deviation 223
|
175 milligrams * hour/deciliter (mg*h/dL)
Standard Deviation 152
|
SECONDARY outcome
Timeframe: Day 1 and 3: -30, -15, 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180,195, 210, 225, 240, and 300 minutes post dosePopulation: All participants who received at least one dose of both study drugs and had evaluable GD data during the breakfast test meal. LOCF was used for last observed glucose values prior to treatment intervention for hypoglycemic or hyperglycemic events.
GD: Change from baseline in AUC (0-5h) of glucose relative to MMTT.
Outcome measures
| Measure |
LY900014 SS
n=22 Participants
Individualized doses of LY900014 delivered via CSII with intermitted bolus dose administered as standard single-wave bolus on Day 1 and 3.
|
Insulin Lispro (Humalog) SS
n=22 Participants
Individualized doses of Insulin lispro (Humalog) delivered via CSII with intermittent bolus dose administered as a standard single-wave bolus on Day 1 and 3.
|
|---|---|---|
|
Glucodynamics (GD): Change From Baseline Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5 h]) of Glucose Relative to MMTT Following Administration of Each Study Arm With a Standard Dual-wave Bolus
Day 1
|
-1.87 mg*h/dL
Standard Deviation 225
|
106 mg*h/dL
Standard Deviation 178
|
|
Glucodynamics (GD): Change From Baseline Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5 h]) of Glucose Relative to MMTT Following Administration of Each Study Arm With a Standard Dual-wave Bolus
Day 3
|
188 mg*h/dL
Standard Deviation 234
|
286 mg*h/dL
Standard Deviation 221
|
Adverse Events
LY900014
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Humalog
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Open-label Humalog
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY900014
n=24 participants at risk
LY900014 administered via CSII
|
Humalog
n=24 participants at risk
Humalog administered via CSII
|
Open-label Humalog
n=24 participants at risk
Humalog administered via CSII as post-blinded study standard of care.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
8.3%
2/24 • Number of events 2 • Baseline through end of study (Up to 11 weeks)
|
16.7%
4/24 • Number of events 6 • Baseline through end of study (Up to 11 weeks)
|
4.2%
1/24 • Number of events 1 • Baseline through end of study (Up to 11 weeks)
|
|
General disorders
Asthenia
|
4.2%
1/24 • Number of events 1 • Baseline through end of study (Up to 11 weeks)
|
4.2%
1/24 • Number of events 2 • Baseline through end of study (Up to 11 weeks)
|
8.3%
2/24 • Number of events 5 • Baseline through end of study (Up to 11 weeks)
|
|
General disorders
Fatigue
|
16.7%
4/24 • Number of events 5 • Baseline through end of study (Up to 11 weeks)
|
8.3%
2/24 • Number of events 5 • Baseline through end of study (Up to 11 weeks)
|
0.00%
0/24 • Baseline through end of study (Up to 11 weeks)
|
|
General disorders
Hunger
|
8.3%
2/24 • Number of events 3 • Baseline through end of study (Up to 11 weeks)
|
4.2%
1/24 • Number of events 1 • Baseline through end of study (Up to 11 weeks)
|
12.5%
3/24 • Number of events 6 • Baseline through end of study (Up to 11 weeks)
|
|
Nervous system disorders
Headache
|
41.7%
10/24 • Number of events 23 • Baseline through end of study (Up to 11 weeks)
|
37.5%
9/24 • Number of events 15 • Baseline through end of study (Up to 11 weeks)
|
20.8%
5/24 • Number of events 5 • Baseline through end of study (Up to 11 weeks)
|
|
Nervous system disorders
Tremor
|
4.2%
1/24 • Number of events 1 • Baseline through end of study (Up to 11 weeks)
|
8.3%
2/24 • Number of events 3 • Baseline through end of study (Up to 11 weeks)
|
12.5%
3/24 • Number of events 4 • Baseline through end of study (Up to 11 weeks)
|
|
Psychiatric disorders
Restlessness
|
25.0%
6/24 • Number of events 14 • Baseline through end of study (Up to 11 weeks)
|
29.2%
7/24 • Number of events 20 • Baseline through end of study (Up to 11 weeks)
|
25.0%
6/24 • Number of events 10 • Baseline through end of study (Up to 11 weeks)
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/24 • Baseline through end of study (Up to 11 weeks)
|
4.2%
1/24 • Number of events 1 • Baseline through end of study (Up to 11 weeks)
|
8.3%
2/24 • Number of events 2 • Baseline through end of study (Up to 11 weeks)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.5%
3/24 • Number of events 3 • Baseline through end of study (Up to 11 weeks)
|
12.5%
3/24 • Number of events 3 • Baseline through end of study (Up to 11 weeks)
|
0.00%
0/24 • Baseline through end of study (Up to 11 weeks)
|
|
Vascular disorders
Phlebitis
|
8.3%
2/24 • Number of events 2 • Baseline through end of study (Up to 11 weeks)
|
8.3%
2/24 • Number of events 2 • Baseline through end of study (Up to 11 weeks)
|
0.00%
0/24 • Baseline through end of study (Up to 11 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60