Trial Outcomes & Findings for A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects (NCT NCT01374178)
NCT ID: NCT01374178
Last Updated: 2014-10-07
Results Overview
AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Periods 1 and 2: Baseline up to 24 hours
Results posted on
2014-10-07
Participant Flow
Participant milestones
| Measure |
LY2963016 First, Then Lantus
A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg Lantus dose was administered subcutaneously during Period 2 (1 period=24 hours).
|
Lantus First, Then LY2963016
A single 0.5-U/kg dose of Lantus was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg dose of LY2963016 was administered subcutaneously during Period 2 (1 period=24 hours).
|
|---|---|---|
|
Period 1 (up to 24 Hours After Dosing)
STARTED
|
11
|
5
|
|
Period 1 (up to 24 Hours After Dosing)
Received at Least 1 Dose of LY2963016
|
11
|
5
|
|
Period 1 (up to 24 Hours After Dosing)
COMPLETED
|
11
|
5
|
|
Period 1 (up to 24 Hours After Dosing)
NOT COMPLETED
|
0
|
0
|
|
Washout Period of at Least 7 Days
STARTED
|
11
|
5
|
|
Washout Period of at Least 7 Days
COMPLETED
|
10
|
5
|
|
Washout Period of at Least 7 Days
NOT COMPLETED
|
1
|
0
|
|
Period 2 (up to 24 Hours After Dosing)
STARTED
|
10
|
5
|
|
Period 2 (up to 24 Hours After Dosing)
COMPLETED
|
8
|
5
|
|
Period 2 (up to 24 Hours After Dosing)
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
LY2963016 First, Then Lantus
A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg Lantus dose was administered subcutaneously during Period 2 (1 period=24 hours).
|
Lantus First, Then LY2963016
A single 0.5-U/kg dose of Lantus was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg dose of LY2963016 was administered subcutaneously during Period 2 (1 period=24 hours).
|
|---|---|---|
|
Washout Period of at Least 7 Days
Withdrawal by Subject
|
1
|
0
|
|
Period 2 (up to 24 Hours After Dosing)
Adverse Event
|
2
|
0
|
Baseline Characteristics
A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=16 Participants
For the LY2963016 first, then Lantus group: A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg Lantus dose was administered subcutaneously during Period 2 (1 period=24 hours).
For the Lantus first, then LY2963016 group: A single 0.5-U/kg dose of Lantus was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg dose of LY2963016 was administered subcutaneously during Period 2 (1 period=24 hours).
|
|---|---|
|
Age, Continuous
|
31.1 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Periods 1 and 2: Baseline up to 24 hoursPopulation: All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable pharmacokinetic data were included in the analysis.
AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure.
Outcome measures
| Measure |
LY2963016
n=16 Participants
A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
|
Lantus
n=13 Participants
A single 0.5-U/kg dose of Lantus was administered subcutaneously.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)
|
1900 picomole*hour per liter (pmol*hr/L)
Geometric Coefficient of Variation 22
|
2180 picomole*hour per liter (pmol*hr/L)
Geometric Coefficient of Variation 30
|
SECONDARY outcome
Timeframe: Periods 1 and 2: Baseline up to 24 hoursPopulation: All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable pharmacokinetic data were included in the analysis.
Outcome measures
| Measure |
LY2963016
n=16 Participants
A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
|
Lantus
n=13 Participants
A single 0.5-U/kg dose of Lantus was administered subcutaneously.
|
|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax)
|
110 picomole per liter (pmol/L)
Geometric Coefficient of Variation 26
|
130 picomole per liter (pmol/L)
Geometric Coefficient of Variation 35
|
SECONDARY outcome
Timeframe: Periods 1 and 2: Baseline up to 24 hoursPopulation: All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable glucodynamic data were included in the analysis.
Outcome measures
| Measure |
LY2963016
n=16 Participants
A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
|
Lantus
n=13 Participants
A single 0.5-U/kg dose of Lantus was administered subcutaneously.
|
|---|---|---|
|
Maximum Glucose Infusion Rate (Rmax)
|
10.2 grams per hour (g/h)
Geometric Coefficient of Variation 50
|
11.3 grams per hour (g/h)
Geometric Coefficient of Variation 32
|
SECONDARY outcome
Timeframe: Periods 1 and 2: Baseline up to 24 hoursPopulation: All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable glucodynamic data were included in the analysis.
Outcome measures
| Measure |
LY2963016
n=16 Participants
A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
|
Lantus
n=13 Participants
A single 0.5-U/kg dose of Lantus was administered subcutaneously.
|
|---|---|---|
|
Total Glucose Infused (Gtot)
|
141 gram (g)
Geometric Coefficient of Variation 54
|
160 gram (g)
Geometric Coefficient of Variation 36
|
SECONDARY outcome
Timeframe: Periods 1 and 2: Baseline up to 24 hoursPopulation: All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable glucodynamic data.
Outcome measures
| Measure |
LY2963016
n=16 Participants
A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
|
Lantus
n=13 Participants
A single 0.5-U/kg dose of Lantus was administered subcutaneously.
|
|---|---|---|
|
Time of Maximum Glucose Infusion Rate (tRmax)
|
10.5 hour (h)
Interval 5.4 to 15.1
|
10.2 hour (h)
Interval 5.5 to 15.8
|
SECONDARY outcome
Timeframe: Baseline up to 30 daysPopulation: All randomized participants were included in the analysis.
Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module.
Outcome measures
| Measure |
LY2963016
n=16 Participants
A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
|
Lantus
n=13 Participants
A single 0.5-U/kg dose of Lantus was administered subcutaneously.
|
|---|---|---|
|
Number of Participants With Clinically Significant Effects
Serious Adverse Events
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Effects
Nonserious Adverse Events
|
8 participants
|
6 participants
|
Adverse Events
LY2963016
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Lantus
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY2963016
n=16 participants at risk
A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
|
Lantus
n=13 participants at risk
A single 0.5-U/kg dose of Lantus was administered subcutaneously.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
6.2%
1/16 • Number of events 2
|
0.00%
0/13
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Catheter site erythema
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
General disorders
Catheter site pain
|
6.2%
1/16 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Catheter site swelling
|
18.8%
3/16 • Number of events 3
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Chest discomfort
|
6.2%
1/16 • Number of events 2
|
0.00%
0/13
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
12.5%
2/16 • Number of events 3
|
0.00%
0/13
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Nervous system disorders
Tremor
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
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