Trial Outcomes & Findings for A Study to Compare the Effect of Giving Dulaglutide Using an Auto-injector Versus a Manual Syringe (NCT NCT01524770)
NCT ID: NCT01524770
Last Updated: 2014-10-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
Predose to 336 hours postdose
Results posted on
2014-10-22
Participant Flow
Participant milestones
| Measure |
Manual Syringe First, Then Auto-injector
First Intervention:
Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe.
There was a washout period of at least 28 days between treatment periods.
Second intervention:
Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by auto-injector.
|
Auto-injector First, Then Manual Syringe
First Intervention:
Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector.
There was a washout period of at least 28 days between treatment periods.
Second intervention:
Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by manual syringe.
|
|---|---|---|
|
First Intervention
STARTED
|
26
|
24
|
|
First Intervention
Received at Least 1 Dose of Study Drug
|
26
|
24
|
|
First Intervention
COMPLETED
|
23
|
23
|
|
First Intervention
NOT COMPLETED
|
3
|
1
|
|
Washout Period of at Least 28 Days
STARTED
|
23
|
23
|
|
Washout Period of at Least 28 Days
COMPLETED
|
23
|
23
|
|
Washout Period of at Least 28 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
23
|
23
|
|
Second Intervention
COMPLETED
|
23
|
23
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Manual Syringe First, Then Auto-injector
First Intervention:
Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe.
There was a washout period of at least 28 days between treatment periods.
Second intervention:
Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by auto-injector.
|
Auto-injector First, Then Manual Syringe
First Intervention:
Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector.
There was a washout period of at least 28 days between treatment periods.
Second intervention:
Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by manual syringe.
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
1
|
0
|
|
First Intervention
Adverse Event
|
1
|
1
|
|
First Intervention
Protocol Violation
|
1
|
0
|
Baseline Characteristics
A Study to Compare the Effect of Giving Dulaglutide Using an Auto-injector Versus a Manual Syringe
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=50 Participants
All participants who received at least one 1.5-milligram (mg) dose of dulaglutide administered subcutaneously via manual syringe or auto-injector.
|
|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 17.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose to 336 hours postdosePopulation: Participants who received at least 1 dose of dulaglutide and have evaluable dulaglutide concentration data.
Outcome measures
| Measure |
Auto-injector
n=47 Participants
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
|
Manual Syringe
n=47 Participants
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC[0-336]) for Dulaglutide
|
14700 nanograms times hours per milliliters
Geometric Coefficient of Variation 22
|
14300 nanograms times hours per milliliters
Geometric Coefficient of Variation 24
|
PRIMARY outcome
Timeframe: Predose to 336 hours postdosePopulation: Participants who received at least 1 dose of dulaglutide and have evaluable dulaglutide concentration data.
Outcome measures
| Measure |
Auto-injector
n=47 Participants
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
|
Manual Syringe
n=48 Participants
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
|
|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) for Dulaglutide
|
91.1 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
88.2 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
SECONDARY outcome
Timeframe: Predose to 336 hours postdosePopulation: Participants who received at least 1 dose of dulaglutide with evaluable concentration-time data.
Outcome measures
| Measure |
Auto-injector
n=47 Participants
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
|
Manual Syringe
n=48 Participants
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
|
|---|---|---|
|
Pharmacokinetics: Time to Maximum Concentration (Tmax) for Dulaglutide
|
48.0 hours
Interval 24.0 to 96.0
|
48.0 hours
Interval 24.0 to 96.0
|
Adverse Events
Auto-injector
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Manual Syringe
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Auto-injector
n=47 participants at risk
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period
|
Manual Syringe
n=49 participants at risk
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
10.6%
5/47 • Number of events 6
|
4.1%
2/49 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/47
|
6.1%
3/49 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
8.5%
4/47 • Number of events 4
|
12.2%
6/49 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/47 • Number of events 1
|
6.1%
3/49 • Number of events 4
|
|
General disorders
Asthenia
|
0.00%
0/47
|
6.1%
3/49 • Number of events 3
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.8%
6/47 • Number of events 6
|
16.3%
8/49 • Number of events 8
|
|
Nervous system disorders
Headache
|
10.6%
5/47 • Number of events 5
|
10.2%
5/49 • Number of events 5
|
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
Restriction type: GT60