Trial Outcomes & Findings for A Study of Dulaglutide in Healthy Participants (NCT NCT03363906)
NCT ID: NCT03363906
Last Updated: 2019-07-29
Results Overview
Pharmacokinetics was assessed in healthy participants to determine the area under the concentration time curve from 0 to infinity (AUC\[0-∞\]) of Dulaglutide.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up: Day 28
Results posted on
2019-07-29
Participant Flow
Participants were randomly assigned into different treatment sequences. Participants in Treatment Sequence A will receive Treatment 1 then Treatment 2. Participants in Treatment Sequence B will receive Treatment 2 then Treatment 1.
Participant milestones
| Measure |
Sequence A Dulaglutide (Reference) Then Dulaglutide (Test)
Dulaglutide (4.5 milligram \[mg\]) administered subcutaneously (SC) in 3 prefilled syringes (PFS) in period 1 and then dulaglutide 4.5 mg administered SC in single dose pen (SDP) in period 2.
|
Sequence B Dulaglutide (Test) Then Dulaglutide (Reference)
Dulaglutide 4.5 mg administered SC in one (SDP) in period 1 and then Dulaglutide 4.5 mg administered SC (PFS) in period 2.
|
|---|---|---|
|
Period 1 (Reference or Test)
STARTED
|
15
|
12
|
|
Period 1 (Reference or Test)
Received at Least One Dose of Study Drug
|
15
|
11
|
|
Period 1 (Reference or Test)
COMPLETED
|
14
|
10
|
|
Period 1 (Reference or Test)
NOT COMPLETED
|
1
|
2
|
|
Period 2 (Test or Reference)
STARTED
|
14
|
10
|
|
Period 2 (Test or Reference)
Received at Least One Dose of Study Drug
|
12
|
9
|
|
Period 2 (Test or Reference)
COMPLETED
|
10
|
9
|
|
Period 2 (Test or Reference)
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Sequence A Dulaglutide (Reference) Then Dulaglutide (Test)
Dulaglutide (4.5 milligram \[mg\]) administered subcutaneously (SC) in 3 prefilled syringes (PFS) in period 1 and then dulaglutide 4.5 mg administered SC in single dose pen (SDP) in period 2.
|
Sequence B Dulaglutide (Test) Then Dulaglutide (Reference)
Dulaglutide 4.5 mg administered SC in one (SDP) in period 1 and then Dulaglutide 4.5 mg administered SC (PFS) in period 2.
|
|---|---|---|
|
Period 1 (Reference or Test)
Adverse Event
|
1
|
2
|
|
Period 2 (Test or Reference)
Adverse Event
|
2
|
0
|
|
Period 2 (Test or Reference)
Withdrawal by Subject
|
1
|
1
|
|
Period 2 (Test or Reference)
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Study of Dulaglutide in Healthy Participants
Baseline characteristics by cohort
| Measure |
Dulaglutide Test and Reference
n=27 Participants
Dulaglutide 4.5 mg administered SC in 3 prefilled syringes and 1 single dose pen in one of two study periods.
|
|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 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
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 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
United States
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up: Day 28Population: All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
Pharmacokinetics was assessed in healthy participants to determine the area under the concentration time curve from 0 to infinity (AUC\[0-∞\]) of Dulaglutide.
Outcome measures
| Measure |
Dulaglutide (Reference)
n=24 Participants
Dulaglutide 4.5 mg administered SC in 3 prefilled syringes in one of two study periods
|
Dulaglutide (Test)
n=23 Participants
Dulaglutide 4.5 mg administered SC in 1 single dose pen in one of two study periods
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Dulaglutide
|
37400 nanogram.hour/milliliter (ng.h/mL)
Geometric Coefficient of Variation 38
|
40000 nanogram.hour/milliliter (ng.h/mL)
Geometric Coefficient of Variation 33
|
PRIMARY outcome
Timeframe: Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up : Day 28Population: All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
Pharmacokinetics was assessed in healthy participants to determine the maximum observed drug concentration (Cmax) of Dulaglutide.
Outcome measures
| Measure |
Dulaglutide (Reference)
n=24 Participants
Dulaglutide 4.5 mg administered SC in 3 prefilled syringes in one of two study periods
|
Dulaglutide (Test)
n=23 Participants
Dulaglutide 4.5 mg administered SC in 1 single dose pen in one of two study periods
|
|---|---|---|
|
PK: Maximum Observed Drug Concentration (Cmax) of Dulaglutide
|
213 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 41
|
240 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
Adverse Events
Dulaglutide (Reference)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Dulaglutide (Test)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dulaglutide (Reference)
n=24 participants at risk
Dulaglutide 4.5 mg administered SC in 3 prefilled syringes in one of two study periods
|
Dulaglutide (Test)
n=23 participants at risk
Dulaglutide 4.5 mg administered SC in 1 single dose pen in one of two study periods
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
16.7%
4/24 • Number of events 4 • Up to 6 months
All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
|
13.0%
3/23 • Number of events 3 • Up to 6 months
All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
2/24 • Number of events 2 • Up to 6 months
All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
|
8.7%
2/23 • Number of events 2 • Up to 6 months
All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
|
|
Gastrointestinal disorders
Nausea
|
45.8%
11/24 • Number of events 13 • Up to 6 months
All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
|
52.2%
12/23 • Number of events 15 • Up to 6 months
All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
|
|
Gastrointestinal disorders
Vomiting
|
20.8%
5/24 • Number of events 5 • Up to 6 months
All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
|
30.4%
7/23 • Number of events 9 • Up to 6 months
All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
|
|
General disorders
Injection site pain
|
8.3%
2/24 • Number of events 3 • Up to 6 months
All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
|
8.7%
2/23 • Number of events 2 • Up to 6 months
All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
|
|
Nervous system disorders
Dizziness
|
16.7%
4/24 • Number of events 5 • Up to 6 months
All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
|
4.3%
1/23 • Number of events 1 • Up to 6 months
All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
|
|
Nervous system disorders
Headache
|
12.5%
3/24 • Number of events 3 • Up to 6 months
All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
|
4.3%
1/23 • Number of events 2 • Up to 6 months
All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60