Trial Outcomes & Findings for A Study of LY2963016 in Healthy Participants (NCT NCT01634165)
NCT ID: NCT01634165
Last Updated: 2014-10-07
Results Overview
Results for LY2936016 treatment arms provide the AUC(0-∞) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-∞) for Lantus.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Predose up to 24 hours after administration of study drug
Results posted on
2014-10-07
Participant Flow
This was a 4-treatment, 4-period, crossover, euglycemic clamp study. Participants were randomly assigned to 1 of 4 dosing sequences.
Participant milestones
| Measure |
0.3 U/kg LY, 0.6 U/kg LY, 0.3 U/kg Lantus, 0.6 U/kg Lantus
Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during Period 1; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 2; Single subcutaneous dose of 0.3 U/kg Lantus during Period 3; Single subcutaneous dose of 0.6 U/kg Lantus during Period 4. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg LY, 0.6 U/kg Lantus, 0.3 U/kg LY, 0.3 U/kg Lantus
Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 1; Single subcutaneous dose of 0.6 U/kg Lantus during Period 2; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 3; Single subcutaneous dose of 0.3 U/kg Lantus during Period 4. There was a minimum washout interval of 6 days between each period.
|
0.3 U/kg Lantus, 0.3 U/kg LY, 0.6 U/kg Lantus, 0.6 U/kg LY
Single subcutaneous dose of 0.3 U/kg Lantus during Period 1; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 2; Single subcutaneous dose of 0.6 U/kg Lantus during Period 3; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 4. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg Lantus, 0.3 U/kg Lantus, 0.6 U/kg LY, 0.3 U/kg LY
Single subcutaneous dose of 0.6 U/kg Lantus during Period 1; Single subcutaneous dose of 0.3 U/kg Lantus during Period 2; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 3; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 4. There was a minimum washout interval of 6 days between each period.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
6
|
6
|
6
|
6
|
|
Period 1
Received at Least 1 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
|
5
|
6
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Period 3
STARTED
|
6
|
5
|
6
|
6
|
|
Period 3
COMPLETED
|
6
|
5
|
6
|
6
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
6
|
5
|
6
|
6
|
|
Period 4
COMPLETED
|
6
|
5
|
6
|
6
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
0.3 U/kg LY, 0.6 U/kg LY, 0.3 U/kg Lantus, 0.6 U/kg Lantus
Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during Period 1; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 2; Single subcutaneous dose of 0.3 U/kg Lantus during Period 3; Single subcutaneous dose of 0.6 U/kg Lantus during Period 4. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg LY, 0.6 U/kg Lantus, 0.3 U/kg LY, 0.3 U/kg Lantus
Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 1; Single subcutaneous dose of 0.6 U/kg Lantus during Period 2; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 3; Single subcutaneous dose of 0.3 U/kg Lantus during Period 4. There was a minimum washout interval of 6 days between each period.
|
0.3 U/kg Lantus, 0.3 U/kg LY, 0.6 U/kg Lantus, 0.6 U/kg LY
Single subcutaneous dose of 0.3 U/kg Lantus during Period 1; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 2; Single subcutaneous dose of 0.6 U/kg Lantus during Period 3; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 4. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg Lantus, 0.3 U/kg Lantus, 0.6 U/kg LY, 0.3 U/kg LY
Single subcutaneous dose of 0.6 U/kg Lantus during Period 1; Single subcutaneous dose of 0.3 U/kg Lantus during Period 2; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 3; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 4. There was a minimum washout interval of 6 days between each period.
|
|---|---|---|---|---|
|
Period 2
Adverse Event
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of LY2963016 in Healthy Participants
Baseline characteristics by cohort
| Measure |
All Participants
n=24 Participants
Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016, or 0.6 U/kg LY2963016, or 0.3 U/kg Lantus, or 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
|---|---|
|
Age, Continuous
|
32.1 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose up to 24 hours after administration of study drugPopulation: All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-∞). Participants were analyzed based on the treatment they received.
Results for LY2936016 treatment arms provide the AUC(0-∞) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-∞) for Lantus.
Outcome measures
| Measure |
0.3 U/kg LY2963016
n=23 Participants
Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg LY2963016
n=24 Participants
Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.3 U/kg Lantus
n=22 Participants
Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg Lantus
n=24 Participants
Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)]
|
2330 picomoles*hour per liter (pmol*h/L)
Geometric Coefficient of Variation 39
|
4470 picomoles*hour per liter (pmol*h/L)
Geometric Coefficient of Variation 15
|
2390 picomoles*hour per liter (pmol*h/L)
Geometric Coefficient of Variation 33
|
4310 picomoles*hour per liter (pmol*h/L)
Geometric Coefficient of Variation 51
|
PRIMARY outcome
Timeframe: Predose up to 24 hours after administration of study drugPopulation: All participants who received study drug and had sufficient pharmacokinetic data to calculate Cmax. Participants were analyzed based on the treatment they received.
Outcome measures
| Measure |
0.3 U/kg LY2963016
n=23 Participants
Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg LY2963016
n=24 Participants
Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.3 U/kg Lantus
n=23 Participants
Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg Lantus
n=24 Participants
Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
|---|---|---|---|---|
|
Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)
|
108 picomoles per liter (pmol/L)
Geometric Coefficient of Variation 20
|
180 picomoles per liter (pmol/L)
Geometric Coefficient of Variation 28
|
105 picomoles per liter (pmol/L)
Geometric Coefficient of Variation 33
|
174 picomoles per liter (pmol/L)
Geometric Coefficient of Variation 38
|
SECONDARY outcome
Timeframe: Predose up to 24 hours after administration of study drugPopulation: All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.
Results for LY2936016 treatment arms provide the AUC(0-24) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-24) for Lantus.
Outcome measures
| Measure |
0.3 U/kg LY2963016
n=23 Participants
Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg LY2963016
n=24 Participants
Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.3 U/kg Lantus
n=23 Participants
Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg Lantus
n=24 Participants
Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus
|
1730 picomoles*hour per liter (pmol*h/L)
Geometric Coefficient of Variation 20
|
3160 picomoles*hour per liter (pmol*h/L)
Geometric Coefficient of Variation 27
|
1690 picomoles*hour per liter (pmol*h/L)
Geometric Coefficient of Variation 30
|
2940 picomoles*hour per liter (pmol*h/L)
Geometric Coefficient of Variation 45
|
SECONDARY outcome
Timeframe: Predose up to 24 hours after administration of study drugPopulation: All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-tlast). Participants were analyzed based on the treatment they received.
Results for LY2936016 treatment arms provide the AUC(0-tlast) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-tlast) for Lantus.
Outcome measures
| Measure |
0.3 U/kg LY2963016
n=23 Participants
Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg LY2963016
n=24 Participants
Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.3 U/kg Lantus
n=23 Participants
Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg Lantus
n=24 Participants
Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) From Time Zero to Last Measured Concentration Value [AUC(0-tlast)] of LY2963016 or Lantus
|
1730 picomoles*hour per liter (pmol*h/L)
Geometric Coefficient of Variation 20
|
3160 picomoles*hour per liter (pmol*h/L)
Geometric Coefficient of Variation 27
|
1670 picomoles*hour per liter (pmol*h/L)
Geometric Coefficient of Variation 28
|
2940 picomoles*hour per liter (pmol*h/L)
Geometric Coefficient of Variation 45
|
SECONDARY outcome
Timeframe: Postdose up to 24 hours after administration of study drugPopulation: All participants who received study drug and had Rmax measurements. Participants were analyzed based on the treatment they received.
Rmax is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.
Outcome measures
| Measure |
0.3 U/kg LY2963016
n=23 Participants
Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg LY2963016
n=24 Participants
Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.3 U/kg Lantus
n=23 Participants
Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg Lantus
n=24 Participants
Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
|---|---|---|---|---|
|
Maximum Glucose Infusion Rate (Rmax)
|
1.81 milligrams/kilograms/minute (mg/kg/min)
Geometric Coefficient of Variation 100
|
3.05 milligrams/kilograms/minute (mg/kg/min)
Geometric Coefficient of Variation 59
|
1.70 milligrams/kilograms/minute (mg/kg/min)
Geometric Coefficient of Variation 92
|
3.25 milligrams/kilograms/minute (mg/kg/min)
Geometric Coefficient of Variation 54
|
SECONDARY outcome
Timeframe: Postdose up to 24 hours after administration of study drugPopulation: All participants who received study drug and had Gtot measurements. Participants were analyzed based on the treatment they received.
Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.
Outcome measures
| Measure |
0.3 U/kg LY2963016
n=23 Participants
Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg LY2963016
n=24 Participants
Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.3 U/kg Lantus
n=23 Participants
Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg Lantus
n=24 Participants
Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
|---|---|---|---|---|
|
Total Amount of Glucose Infused (Gtot)
|
1060 milligrams per kilograms (mg/kg)
Geometric Coefficient of Variation 178
|
2260 milligrams per kilograms (mg/kg)
Geometric Coefficient of Variation 80
|
1050 milligrams per kilograms (mg/kg)
Geometric Coefficient of Variation 130
|
2590 milligrams per kilograms (mg/kg)
Geometric Coefficient of Variation 62
|
Adverse Events
0.3 U/kg LY2963016
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
0.6 U/kg LY2963016
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
0.3 U/kg Lantus
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
0.6 U/kg Lantus
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.3 U/kg LY2963016
n=23 participants at risk
Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg LY2963016
n=24 participants at risk
Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.3 U/kg Lantus
n=23 participants at risk
Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg Lantus
n=24 participants at risk
Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/23
|
0.00%
0/24
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
Other adverse events
| Measure |
0.3 U/kg LY2963016
n=23 participants at risk
Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg LY2963016
n=24 participants at risk
Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.3 U/kg Lantus
n=23 participants at risk
Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
0.6 U/kg Lantus
n=24 participants at risk
Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/23
|
0.00%
0/24
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/23
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/23
|
0.00%
0/24
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
0.00%
0/24
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/23
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23
|
8.3%
2/24 • Number of events 3
|
0.00%
0/23
|
4.2%
1/24 • Number of events 3
|
|
General disorders
Application site erythema
|
0.00%
0/23
|
0.00%
0/24
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Application site haematoma
|
4.3%
1/23 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
8.7%
2/23 • Number of events 2
|
12.5%
3/24 • Number of events 3
|
|
General disorders
Injection site erythema
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
0.00%
0/24
|
|
General disorders
Injection site pruritus
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/23
|
0.00%
0/24
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
4.3%
1/23 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
13.0%
3/23 • Number of events 3
|
4.2%
1/24 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
4.3%
1/23 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
17.4%
4/23 • Number of events 4
|
8.3%
2/24 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/23
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/23
|
0.00%
0/24
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/23
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
8.3%
2/24 • Number of events 3
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/23
|
0.00%
0/24
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
0.00%
0/24
|
|
Nervous system disorders
Lethargy
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.3%
1/23 • Number of events 1
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/23
|
0.00%
0/24
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/23
|
0.00%
0/24
|
4.3%
1/23 • Number of events 1
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/23
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
0.00%
0/24
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place