Trial Outcomes & Findings for A Study of the Effect of LY2189265 on Two Blood Pressure Drugs (NCT NCT01324388)
NCT ID: NCT01324388
Last Updated: 2014-10-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
51 participants
Primary outcome timeframe
Day -1, Day 3, Day 24 of Part 1
Results posted on
2014-10-08
Participant Flow
Participant milestones
| Measure |
Part 1: LY2189265 + Lisinopril
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
Part 1: Placebo + Lisinopril
Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
Part 2: LY2189265 First, Then LY2189265 + Metoprolol
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1 of Treatment 1 and on Day 5 of Treatment 2 in Part 2 of the study.
Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 2 in Part 2 of the study.
There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 of Treatment 1 to Day 1 of Treatment 2 in Part 2 of the study).
|
Part 2: LY2189265 + Metoprolol First, Then LY2189265
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 of Treatment 2 and on Day 1 of Treatment 1 in Part 2 of the study.
Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 1 in Part 2 of the study.
There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 7 of Treatment 2 to Day 1 of Treatment 1 in Part 2 of the study).
|
|---|---|---|---|---|
|
Part 1 of Study
STARTED
|
23
|
8
|
0
|
0
|
|
Part 1 of Study
Received at Least 1 Dose
|
23
|
8
|
0
|
0
|
|
Part 1 of Study
COMPLETED
|
19
|
6
|
0
|
0
|
|
Part 1 of Study
NOT COMPLETED
|
4
|
2
|
0
|
0
|
|
Part 2 of Study: First Intervention
STARTED
|
0
|
0
|
10
|
10
|
|
Part 2 of Study: First Intervention
COMPLETED
|
0
|
0
|
10
|
9
|
|
Part 2 of Study: First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Part 2: Washout of at Least 21 Days
STARTED
|
0
|
0
|
10
|
9
|
|
Part 2: Washout of at Least 21 Days
COMPLETED
|
0
|
0
|
10
|
9
|
|
Part 2: Washout of at Least 21 Days
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 2 of Study: Second Intervention
STARTED
|
0
|
0
|
10
|
9
|
|
Part 2 of Study: Second Intervention
COMPLETED
|
0
|
0
|
9
|
9
|
|
Part 2 of Study: Second Intervention
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Part 1: LY2189265 + Lisinopril
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
Part 1: Placebo + Lisinopril
Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
Part 2: LY2189265 First, Then LY2189265 + Metoprolol
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1 of Treatment 1 and on Day 5 of Treatment 2 in Part 2 of the study.
Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 2 in Part 2 of the study.
There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 of Treatment 1 to Day 1 of Treatment 2 in Part 2 of the study).
|
Part 2: LY2189265 + Metoprolol First, Then LY2189265
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 of Treatment 2 and on Day 1 of Treatment 1 in Part 2 of the study.
Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 1 in Part 2 of the study.
There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 7 of Treatment 2 to Day 1 of Treatment 1 in Part 2 of the study).
|
|---|---|---|---|---|
|
Part 1 of Study
Adverse Event
|
2
|
0
|
0
|
0
|
|
Part 1 of Study
Protocol Violation
|
1
|
2
|
0
|
0
|
|
Part 1 of Study
Physician Decision
|
1
|
0
|
0
|
0
|
|
Part 2 of Study: First Intervention
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Part 2 of Study: Second Intervention
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of the Effect of LY2189265 on Two Blood Pressure Drugs
Baseline characteristics by cohort
| Measure |
Part 1: LY2189265 + Lisinopril
n=23 Participants
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
Part 1: Placebo + Lisinopril
n=8 Participants
Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
Part 2: LY2189265 + Metoprolol Crossover
n=20 Participants
Participants received 2 treatments in Part 2 of the study:
Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1
Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7
Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:
Treatment Sequence A: Treatment 1, Treatment 2
Treatment Sequence B: Treatment 2, Treatment 1
There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B).
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
44.6 years
STANDARD_DEVIATION 16.7 • n=5 Participants
|
51.8 years
STANDARD_DEVIATION 14.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
12 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
8 participants
n=7 Participants
|
20 participants
n=5 Participants
|
51 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day -1, Day 3, Day 24 of Part 1Population: Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable lisinopril AUC data.
Outcome measures
| Measure |
Part 1: LY2189265 + Lisinopril
n=23 Participants
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
Part 1: Placebo + Lisinopril
n=8 Participants
Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
|---|---|---|
|
Pharmacokinetics, Area Under the Concentration Curve (AUC) of Lisinopril
Day -1 (Baseline)
|
1580 (nanograms*hours/milliliter)/milligram
Geometric Coefficient of Variation 55
|
1740 (nanograms*hours/milliliter)/milligram
Geometric Coefficient of Variation 26
|
|
Pharmacokinetics, Area Under the Concentration Curve (AUC) of Lisinopril
Day 3 (n=22, 8)
|
1660 (nanograms*hours/milliliter)/milligram
Geometric Coefficient of Variation 56
|
1720 (nanograms*hours/milliliter)/milligram
Geometric Coefficient of Variation 28
|
|
Pharmacokinetics, Area Under the Concentration Curve (AUC) of Lisinopril
Day 24 (n=18, 6)
|
1540 (nanograms*hours/milliliter)/milligram
Geometric Coefficient of Variation 52
|
1390 (nanograms*hours/milliliter)/milligram
Geometric Coefficient of Variation 38
|
PRIMARY outcome
Timeframe: Day -1, Day 3, Day 24 in Part 1Population: Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable lisinopril Cmax data.
Outcome measures
| Measure |
Part 1: LY2189265 + Lisinopril
n=23 Participants
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
Part 1: Placebo + Lisinopril
n=8 Participants
Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
|---|---|---|
|
Pharmacokinetics, Maximum Concentration (Cmax) of Lisinopril
Day -1 (Baseline)
|
122 (nanograms per milliliter) per milligram
Geometric Coefficient of Variation 56
|
138 (nanograms per milliliter) per milligram
Geometric Coefficient of Variation 22
|
|
Pharmacokinetics, Maximum Concentration (Cmax) of Lisinopril
Day 3 (n=22, 8)
|
114 (nanograms per milliliter) per milligram
Geometric Coefficient of Variation 55
|
138 (nanograms per milliliter) per milligram
Geometric Coefficient of Variation 25
|
|
Pharmacokinetics, Maximum Concentration (Cmax) of Lisinopril
Day 24 (n=18, 6)
|
115 (nanograms per milliliter) per milligram
Geometric Coefficient of Variation 49
|
110 (nanograms per milliliter) per milligram
Geometric Coefficient of Variation 39
|
PRIMARY outcome
Timeframe: Day -1, Day 4, Day 7 of Treatment 2 in Part 2Population: Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 ABPM heart rate data.
Outcome measures
| Measure |
Part 1: LY2189265 + Lisinopril
n=19 Participants
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
Part 1: Placebo + Lisinopril
Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
|---|---|---|
|
Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol
Day -1 (Baseline)
|
63.7 beats per minute (bpm)
Standard Deviation 9.6
|
—
|
|
Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol
Day 4 (n=18)
|
55.8 beats per minute (bpm)
Standard Deviation 9.4
|
—
|
|
Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol
Day 7
|
69.4 beats per minute (bpm)
Standard Deviation 9.0
|
—
|
PRIMARY outcome
Timeframe: Day -1, Day 4, Day 7 of Treatment 2 in Part 2Population: Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 ABPM blood pressure data.
Outcome measures
| Measure |
Part 1: LY2189265 + Lisinopril
n=19 Participants
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
Part 1: Placebo + Lisinopril
Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
|---|---|---|
|
Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol
Diastolic, Day 7
|
71.8 millimeter of mercury (mm Hg)
Standard Deviation 6.4
|
—
|
|
Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol
Systolic, Day -1 (Baseline)
|
123.0 millimeter of mercury (mm Hg)
Standard Deviation 11.4
|
—
|
|
Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol
Systolic, Day 4 (n=18)
|
115.4 millimeter of mercury (mm Hg)
Standard Deviation 11.7
|
—
|
|
Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol
Systolic, Day 7
|
116.2 millimeter of mercury (mm Hg)
Standard Deviation 10.4
|
—
|
|
Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol
Diastolic, Day -1 (Baseline)
|
72.8 millimeter of mercury (mm Hg)
Standard Deviation 7.3
|
—
|
|
Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol
Diastolic, Day 4 (n=18)
|
67.2 millimeter of mercury (mm Hg)
Standard Deviation 7.5
|
—
|
SECONDARY outcome
Timeframe: Day -1, Day 3, Day 24 of Part 1Population: Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable Part 1 ABPM heart rate data.
Outcome measures
| Measure |
Part 1: LY2189265 + Lisinopril
n=22 Participants
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
Part 1: Placebo + Lisinopril
n=6 Participants
Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
|---|---|---|
|
Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril
Day -1 (Baseline)
|
69.8 beats per minute (bpm)
Standard Deviation 8.9
|
68.9 beats per minute (bpm)
Standard Deviation 6.6
|
|
Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril
Day 3 (n=21, 6)
|
78.3 beats per minute (bpm)
Standard Deviation 7.9
|
69.3 beats per minute (bpm)
Standard Deviation 9.0
|
|
Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril
Day 24 (n=18, 6)
|
77.1 beats per minute (bpm)
Standard Deviation 9.0
|
71.6 beats per minute (bpm)
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: Day -1, Day 3, Day 24 of Part 1Population: Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable Part 1 ABPM blood pressure data.
Outcome measures
| Measure |
Part 1: LY2189265 + Lisinopril
n=22 Participants
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
Part 1: Placebo + Lisinopril
n=6 Participants
Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
|---|---|---|
|
Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril
Systolic, Day -1 (Baseline)
|
129.4 millimeter of mercury (mm Hg)
Standard Deviation 14.1
|
130.1 millimeter of mercury (mm Hg)
Standard Deviation 14.9
|
|
Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril
Systolic, Day 3 (n=21, 6)
|
125.3 millimeter of mercury (mm Hg)
Standard Deviation 11.5
|
127.1 millimeter of mercury (mm Hg)
Standard Deviation 13.4
|
|
Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril
Systolic, Day 24 (n=18, 6)
|
121.1 millimeter of mercury (mm Hg)
Standard Deviation 10.3
|
123.8 millimeter of mercury (mm Hg)
Standard Deviation 16.2
|
|
Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril
Diastolic, Day -1 (Baseline)
|
76.9 millimeter of mercury (mm Hg)
Standard Deviation 8.6
|
74.1 millimeter of mercury (mm Hg)
Standard Deviation 7.7
|
|
Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril
Diastolic, Day 3 (n=21, 6)
|
77.1 millimeter of mercury (mm Hg)
Standard Deviation 8.3
|
72.6 millimeter of mercury (mm Hg)
Standard Deviation 5.1
|
|
Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril
Diastolic, Day 24 (n=18, 6)
|
73.8 millimeter of mercury (mm Hg)
Standard Deviation 9.4
|
71.2 millimeter of mercury (mm Hg)
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Day 4 and Day 7 of Treatment 2 in Part 2Population: Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 metoprolol AUC data.
Outcome measures
| Measure |
Part 1: LY2189265 + Lisinopril
n=20 Participants
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
Part 1: Placebo + Lisinopril
Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
|---|---|---|
|
Pharmacokinetics, Area Under the Concentration Curve (AUC) of Metoprolol When Administered With LY2189265
Day 4
|
617 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 69
|
—
|
|
Pharmacokinetics, Area Under the Concentration Curve (AUC) of Metoprolol When Administered With LY2189265
Day 7 (n=17)
|
813 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 63
|
—
|
SECONDARY outcome
Timeframe: Day 4 and Day 7 of Treatment 2 in Part 2Population: Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 metoprolol Cmax data.
Outcome measures
| Measure |
Part 1: LY2189265 + Lisinopril
n=20 Participants
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
Part 1: Placebo + Lisinopril
Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
|---|---|---|
|
Pharmacokinetics, Maximum Concentration (Cmax) of Metoprolol When Administered With LY2189265
Day 4
|
35.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 63
|
—
|
|
Pharmacokinetics, Maximum Concentration (Cmax) of Metoprolol When Administered With LY2189265
Day 7 (n=19)
|
47.2 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 66
|
—
|
Adverse Events
Part 1: LY2189265 + Lisinopril
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Part 1: Placebo + Lisinopril
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2: LY2189265
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 2: Metoprolol
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2: LY2189265 + Metoprolol
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: LY2189265 + Lisinopril
n=23 participants at risk
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
Part 1: Placebo + Lisinopril
n=8 participants at risk
Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
|
Part 2: LY2189265
n=19 participants at risk
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1 of Treatment 1 in Part 2 of the study.
Time frame: Treatment 1
|
Part 2: Metoprolol
n=20 participants at risk
Metoprolol: 100 milligrams (mg), oral, on Days 1 through 4 of Treatment 2 in Part 2 of the study.
Time frame: Days 1 to 4 of Treatment 2
|
Part 2: LY2189265 + Metoprolol
n=19 participants at risk
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 of Treatment 2 in Part 2 of the study.
Metoprolol: 100 mg, oral, on Days 5 through 7 of Treatment 2 in Part 2 of the study.
Time frame: Day 5 to end of Treatment 2
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/23
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/23
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
17.4%
4/23 • Number of events 5
|
0.00%
0/8
|
5.3%
1/19 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
1/23 • Number of events 1
|
0.00%
0/8
|
0.00%
0/19
|
10.0%
2/20 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
21.7%
5/23 • Number of events 8
|
0.00%
0/8
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
0.00%
0/19
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/23
|
12.5%
1/8 • Number of events 1
|
0.00%
0/19
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
21.7%
5/23 • Number of events 5
|
0.00%
0/8
|
26.3%
5/19 • Number of events 5
|
0.00%
0/20
|
26.3%
5/19 • Number of events 6
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/23
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
2/23 • Number of events 3
|
0.00%
0/8
|
10.5%
2/19 • Number of events 2
|
0.00%
0/20
|
10.5%
2/19 • Number of events 2
|
|
General disorders
Asthenia
|
0.00%
0/23
|
0.00%
0/8
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
0.00%
0/19
|
|
General disorders
Catheter site haematoma
|
0.00%
0/23
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/20
|
5.3%
1/19 • Number of events 2
|
|
General disorders
Device failure
|
0.00%
0/23
|
0.00%
0/8
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
|
General disorders
Fatigue
|
0.00%
0/23
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/20
|
10.5%
2/19 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
1/23 • Number of events 1
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Viral infection
|
0.00%
0/23
|
12.5%
1/8 • Number of events 1
|
0.00%
0/19
|
0.00%
0/20
|
0.00%
0/19
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/23
|
0.00%
0/8
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
0.00%
0/19
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/23
|
12.5%
1/8 • Number of events 1
|
0.00%
0/19
|
0.00%
0/20
|
0.00%
0/19
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/23
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/23
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.1%
6/23 • Number of events 6
|
0.00%
0/8
|
31.6%
6/19 • Number of events 6
|
0.00%
0/20
|
36.8%
7/19 • Number of events 7
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/23
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/23
|
0.00%
0/8
|
5.3%
1/19 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
|
Nervous system disorders
Headache
|
13.0%
3/23 • Number of events 4
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Parosmia
|
0.00%
0/23
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23
|
0.00%
0/8
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/23
|
0.00%
0/8
|
0.00%
0/19
|
0.00%
0/20
|
5.3%
1/19 • 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
Restriction type: GT60