Trial Outcomes & Findings for A Study of LY900014 in Participants With Type 1 Diabetes Mellitus (NCT NCT03465878)
NCT ID: NCT03465878
Last Updated: 2020-06-18
Results Overview
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes postdose
Results posted on
2020-06-18
Participant Flow
Participants (pts) who completed Part A but discontinued before the beginning of Part B were replaced by newly enrolled participants in Part B.
Two period crossover study, with a minimum of 22 days washout period between each period.
Participant milestones
| Measure |
Sequence 1-Part A
Participants received either single 0.2 units per kilogram (U/kg) of body weight subcutaneous (SC) bolus injection of 100 units per milliliter (U/mL) LY900014 or Humalog.
Period 1: LY900014 Period 2: Humalog
|
Sequence 2-Part A
Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014 or Humalog.
Period 1: Humalog Period 2: LY900014
|
Sequence 1-Part B
Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus infusion of 100 U/mL LY900014 or Humalog delivered using the continuous subcutaneous insulin infusion (CSII) pump.
Period 1: LY900014 Period 2: Humalog
|
Sequence 2-Part B
Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus infusion of 100 U/mL LY900014 or Humalog with delivered using the CSII pump.
Period 1: Humalog Period 2: LY900014
|
|---|---|---|---|---|
|
Period 1-Part A First Intervention Day 1
STARTED
|
21
|
21
|
0
|
0
|
|
Period 1-Part A First Intervention Day 1
Received at Least 1 Dose of Study Drug
|
21
|
21
|
0
|
0
|
|
Period 1-Part A First Intervention Day 1
Children (2-11 Years)
|
7
|
6
|
0
|
0
|
|
Period 1-Part A First Intervention Day 1
Adolescents (12-17 Years)
|
7
|
7
|
0
|
0
|
|
Period 1-Part A First Intervention Day 1
Adults (18-64 Years)
|
7
|
8
|
0
|
0
|
|
Period 1-Part A First Intervention Day 1
COMPLETED
|
21
|
20
|
0
|
0
|
|
Period 1-Part A First Intervention Day 1
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Period2-Part A Second Intervention Day 1
STARTED
|
21
|
20
|
0
|
0
|
|
Period2-Part A Second Intervention Day 1
Children (2-11 Years)
|
7
|
6
|
0
|
0
|
|
Period2-Part A Second Intervention Day 1
Adolescents (12-17 Years)
|
7
|
7
|
0
|
0
|
|
Period2-Part A Second Intervention Day 1
Adults (18-64 Years)
|
7
|
7
|
0
|
0
|
|
Period2-Part A Second Intervention Day 1
COMPLETED
|
21
|
20
|
0
|
0
|
|
Period2-Part A Second Intervention Day 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 1-Part B First Intervention Day 1
STARTED
|
0
|
0
|
20
|
19
|
|
Period 1-Part B First Intervention Day 1
Received at Least 1 Dose of Study Drug
|
0
|
0
|
20
|
17
|
|
Period 1-Part B First Intervention Day 1
Children (2-11 Years)
|
0
|
0
|
6
|
6
|
|
Period 1-Part B First Intervention Day 1
Adolescents (12-17 Years)
|
0
|
0
|
7
|
6
|
|
Period 1-Part B First Intervention Day 1
Adults (18-64 Years)
|
0
|
0
|
7
|
5
|
|
Period 1-Part B First Intervention Day 1
COMPLETED
|
0
|
0
|
20
|
17
|
|
Period 1-Part B First Intervention Day 1
NOT COMPLETED
|
0
|
0
|
0
|
2
|
|
Period2-Part B Second Intervention Day 1
STARTED
|
0
|
0
|
20
|
17
|
|
Period2-Part B Second Intervention Day 1
Children (2-11 Years)
|
0
|
0
|
6
|
6
|
|
Period2-Part B Second Intervention Day 1
Adolescents (12-17 Years)
|
0
|
0
|
7
|
6
|
|
Period2-Part B Second Intervention Day 1
Adults (18-64 Years)
|
0
|
0
|
7
|
5
|
|
Period2-Part B Second Intervention Day 1
COMPLETED
|
0
|
0
|
20
|
17
|
|
Period2-Part B Second Intervention Day 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1-Part A
Participants received either single 0.2 units per kilogram (U/kg) of body weight subcutaneous (SC) bolus injection of 100 units per milliliter (U/mL) LY900014 or Humalog.
Period 1: LY900014 Period 2: Humalog
|
Sequence 2-Part A
Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014 or Humalog.
Period 1: Humalog Period 2: LY900014
|
Sequence 1-Part B
Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus infusion of 100 U/mL LY900014 or Humalog delivered using the continuous subcutaneous insulin infusion (CSII) pump.
Period 1: LY900014 Period 2: Humalog
|
Sequence 2-Part B
Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus infusion of 100 U/mL LY900014 or Humalog with delivered using the CSII pump.
Period 1: Humalog Period 2: LY900014
|
|---|---|---|---|---|
|
Period 1-Part A First Intervention Day 1
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Period 1-Part B First Intervention Day 1
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Period 1-Part B First Intervention Day 1
Physician Decision
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of LY900014 in Participants With Type 1 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Part A
n=42 Participants
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014 or Humalog.
|
Part B
n=14 Participants
Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus infusion of either 100 U/mL LY900014 or Humalog delivered using the CSII pump.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.5 Years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
23.2 Years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
21.2 Years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Age, Customized
Children (2-11 Years)
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
14 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Customized
Adults (18-64 years)
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
54 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 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
Canada
|
28 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part.
Outcome measures
| Measure |
Children-LY900014-Part A
n=13 Participants
Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014.
|
Children-Humalog-Part A
n=13 Participants
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
|
Adolescents-LY900014-Part A
n=14 Participants
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.
|
Adolescents-Humalog-Part A
n=14 Participants
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
|
Adults-LY900014-Part A
n=14 Participants
Participants received single 0.2 U/kg of body weight SC bolus injection of 100U/mL LY900014.
|
Adults-Humalog-Part A
n=14 Participants
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
|
Children-LY900014-Part B
n=11 Participants
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
|
Children-Humalog-Part B
n=11 Participants
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
|
Adolescents-LY900014-Part B
n=13 Participants
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
|
Adolescents-Humalog-Part B
n=13 Participants
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
|
Adults-LY900014-Part B
n=12 Participants
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
|
Adults-Humalog-Part B
n=12 Participants
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part
|
755 Picomoles*hour/Liter (pmol*h/L)
Geometric Coefficient of Variation 15
|
754 Picomoles*hour/Liter (pmol*h/L)
Geometric Coefficient of Variation 17
|
962 Picomoles*hour/Liter (pmol*h/L)
Geometric Coefficient of Variation 17
|
908 Picomoles*hour/Liter (pmol*h/L)
Geometric Coefficient of Variation 21
|
987 Picomoles*hour/Liter (pmol*h/L)
Geometric Coefficient of Variation 20
|
975 Picomoles*hour/Liter (pmol*h/L)
Geometric Coefficient of Variation 21
|
743 Picomoles*hour/Liter (pmol*h/L)
Geometric Coefficient of Variation 17
|
714 Picomoles*hour/Liter (pmol*h/L)
Geometric Coefficient of Variation 17
|
842 Picomoles*hour/Liter (pmol*h/L)
Geometric Coefficient of Variation 20
|
866 Picomoles*hour/Liter (pmol*h/L)
Geometric Coefficient of Variation 16
|
1100 Picomoles*hour/Liter (pmol*h/L)
Geometric Coefficient of Variation 35
|
1070 Picomoles*hour/Liter (pmol*h/L)
Geometric Coefficient of Variation 35
|
SECONDARY outcome
Timeframe: -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 received at least one dose of study drug and had evaluable Glucodynamics data.
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve (BG∆AUC(0-5h)) Following Each Treatment Arm for Each Study Part.
Outcome measures
| Measure |
Children-LY900014-Part A
n=12 Participants
Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014.
|
Children-Humalog-Part A
n=12 Participants
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
|
Adolescents-LY900014-Part A
n=13 Participants
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.
|
Adolescents-Humalog-Part A
n=13 Participants
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
|
Adults-LY900014-Part A
n=14 Participants
Participants received single 0.2 U/kg of body weight SC bolus injection of 100U/mL LY900014.
|
Adults-Humalog-Part A
n=14 Participants
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
|
Children-LY900014-Part B
n=10 Participants
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
|
Children-Humalog-Part B
n=10 Participants
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
|
Adolescents-LY900014-Part B
n=13 Participants
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
|
Adolescents-Humalog-Part B
n=13 Participants
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
|
Adults-LY900014-Part B
n=12 Participants
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
|
Adults-Humalog-Part B
n=12 Participants
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part
|
384 milligrams*hour per deciliter (mg*h/dL)
Standard Deviation 335
|
492 milligrams*hour per deciliter (mg*h/dL)
Standard Deviation 270
|
577 milligrams*hour per deciliter (mg*h/dL)
Standard Deviation 247
|
651 milligrams*hour per deciliter (mg*h/dL)
Standard Deviation 238
|
372 milligrams*hour per deciliter (mg*h/dL)
Standard Deviation 179
|
351 milligrams*hour per deciliter (mg*h/dL)
Standard Deviation 240
|
602 milligrams*hour per deciliter (mg*h/dL)
Standard Deviation 221
|
582 milligrams*hour per deciliter (mg*h/dL)
Standard Deviation 254
|
614 milligrams*hour per deciliter (mg*h/dL)
Standard Deviation 160
|
614 milligrams*hour per deciliter (mg*h/dL)
Standard Deviation 163
|
343 milligrams*hour per deciliter (mg*h/dL)
Standard Deviation 194
|
401 milligrams*hour per deciliter (mg*h/dL)
Standard Deviation 235
|
Adverse Events
Children-LY900014-Part A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Children-Humalog-Part A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Adolescents-LY900014-Part A
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Adolescents-Humalog-Part A
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Adults-LY900014-Part A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Adults-Humalog-Part A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Children-LY900014-Part B
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Children-Humalog-Part B
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Adolescents-LY900014-Part B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Adolescents-Humalog-Part B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Adults-LY900014-Part B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Adults-Humalog-Part B
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Children-LY900014-Part A
n=13 participants at risk
Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014.
|
Children-Humalog-Part A
n=13 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
|
Adolescents-LY900014-Part A
n=14 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.
|
Adolescents-Humalog-Part A
n=14 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
|
Adults-LY900014-Part A
n=14 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus injection of 100U/mL LY900014.
|
Adults-Humalog-Part A
n=15 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
|
Children-LY900014-Part B
n=12 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
|
Children-Humalog-Part B
n=12 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
|
Adolescents-LY900014-Part B
n=13 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
|
Adolescents-Humalog-Part B
n=13 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
|
Adults-LY900014-Part B
n=12 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
|
Adults-Humalog-Part B
n=12 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Children-LY900014-Part A
n=13 participants at risk
Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014.
|
Children-Humalog-Part A
n=13 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
|
Adolescents-LY900014-Part A
n=14 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.
|
Adolescents-Humalog-Part A
n=14 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
|
Adults-LY900014-Part A
n=14 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus injection of 100U/mL LY900014.
|
Adults-Humalog-Part A
n=15 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.
|
Children-LY900014-Part B
n=12 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
|
Children-Humalog-Part B
n=12 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
|
Adolescents-LY900014-Part B
n=13 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
|
Adolescents-Humalog-Part B
n=13 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
|
Adults-LY900014-Part B
n=12 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.
|
Adults-Humalog-Part B
n=12 participants at risk
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Feeling hot
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site discomfort
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site erythema
|
15.4%
2/13 • Number of events 2 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site pain
|
7.7%
1/13 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site pruritus
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Acne pustular
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
1/13 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
15.4%
2/13 • Number of events 2 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.7%
1/13 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.7%
1/13 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • From Baseline to Study Completion (Up to 20 Months)
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