Trial Outcomes & Findings for A Study of LY2189102 in Patients With Type 2 Diabetes (NCT NCT00942188)
NCT ID: NCT00942188
Last Updated: 2019-09-18
Results Overview
Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline HbA1c as a continuous covariate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
106 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2019-09-18
Participant Flow
Participant milestones
| Measure |
0.6 mg LY2189102
Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
|
18 mg LY2189102
Participants received 2 SC injections weekly for 12 weeks.
|
180 mg LY2189102
Participants received 2 SC injections weekly for 12 weeks.
|
Placebo
Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
27
|
27
|
|
Overall Study
COMPLETED
|
22
|
16
|
18
|
23
|
|
Overall Study
NOT COMPLETED
|
4
|
10
|
9
|
4
|
Reasons for withdrawal
| Measure |
0.6 mg LY2189102
Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
|
18 mg LY2189102
Participants received 2 SC injections weekly for 12 weeks.
|
180 mg LY2189102
Participants received 2 SC injections weekly for 12 weeks.
|
Placebo
Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
4
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
|
Overall Study
Sponsor Decision
|
0
|
2
|
0
|
1
|
Baseline Characteristics
A Study of LY2189102 in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
0.6 mg LY2189102
n=26 Participants
Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
|
18 mg LY2189102
n=26 Participants
Participants received 2 SC injections weekly for 12 weeks.
|
180 mg LY2189102
n=27 Participants
Participants received 2 SC injections weekly for 12 weeks.
|
Placebo
n=27 Participants
Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 6.75 • n=99 Participants
|
53.7 years
STANDARD_DEVIATION 10.74 • n=107 Participants
|
51.3 years
STANDARD_DEVIATION 9.17 • n=206 Participants
|
52.9 years
STANDARD_DEVIATION 9.41 • n=7 Participants
|
52.7 years
STANDARD_DEVIATION 9.05 • n=31 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
67 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
39 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
6 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
38 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
African
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
15 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
49 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
106 Participants
n=31 Participants
|
|
Percentage of Glycosylated Fraction of Hemoglobin (HbA1c)
|
7.540 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.5596 • n=99 Participants
|
7.950 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.7002 • n=107 Participants
|
8.271 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.9380 • n=206 Participants
|
7.824 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.6557 • n=7 Participants
|
7.882 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.7544 • n=31 Participants
|
|
Fasting Glucose
|
8.152 millimoles per liter (mmol/L)
STANDARD_DEVIATION 1.8154 • n=99 Participants
|
9.106 millimoles per liter (mmol/L)
STANDARD_DEVIATION 2.2001 • n=107 Participants
|
10.300 millimoles per liter (mmol/L)
STANDARD_DEVIATION 2.1440 • n=206 Participants
|
9.339 millimoles per liter (mmol/L)
STANDARD_DEVIATION 1.7315 • n=7 Participants
|
9.208 millimoles per liter (mmol/L)
STANDARD_DEVIATION 2.0688 • n=31 Participants
|
|
Fasting Insulin
|
15.083 microinternational units per milliliter
STANDARD_DEVIATION 12.0562 • n=99 Participants
|
15.034 microinternational units per milliliter
STANDARD_DEVIATION 6.9383 • n=107 Participants
|
13.989 microinternational units per milliliter
STANDARD_DEVIATION 14.4076 • n=206 Participants
|
15.120 microinternational units per milliliter
STANDARD_DEVIATION 12.5253 • n=7 Participants
|
14.821 microinternational units per milliliter
STANDARD_DEVIATION 11.7856 • n=31 Participants
|
|
High-sensitivity C-reactive Protein (hsCRP)
|
6.214 milligrams per liter (mg/L)
STANDARD_DEVIATION 6.2179 • n=99 Participants
|
6.024 milligrams per liter (mg/L)
STANDARD_DEVIATION 4.4956 • n=107 Participants
|
7.183 milligrams per liter (mg/L)
STANDARD_DEVIATION 6.9691 • n=206 Participants
|
6.093 milligrams per liter (mg/L)
STANDARD_DEVIATION 4.5289 • n=7 Participants
|
6.373 milligrams per liter (mg/L)
STANDARD_DEVIATION 5.5685 • n=31 Participants
|
|
Body Mass Index (BMI)
|
33.0 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.73 • n=99 Participants
|
33.7 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.72 • n=107 Participants
|
33.1 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 4.02 • n=206 Participants
|
32.5 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 4.62 • n=7 Participants
|
33.1 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 4.01 • n=31 Participants
|
|
Number of Participants on Diet and Exercise Only
Diet and Exercise Only - Yes
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Number of Participants on Diet and Exercise Only
Diet and Exercise Only - No
|
21 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
87 Participants
n=31 Participants
|
|
Number of Participants on Anti-diabetic Medications
Biguanides
|
20 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
85 Participants
n=31 Participants
|
|
Number of Participants on Anti-diabetic Medications
Glucagon-like Peptide (GLP) Analogs and Agonists
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Number of Participants on Anti-diabetic Medications
DPP-4 Inhibitors
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Number of Participants on Anti-diabetic Medications
Enhancers of Insulin Effects
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Number of Participants on Anti-diabetic Medications
Sufonylureas
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned.
Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline HbA1c as a continuous covariate.
Outcome measures
| Measure |
0.6 mg LY2189102
n=21 Participants
Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
|
18 mg LY2189102
n=16 Participants
Participants received 2 SC injections weekly for 12 weeks.
|
180 mg LY2189102
n=19 Participants
Participants received 2 SC injections weekly for 12 weeks.
|
Placebo
n=23 Participants
Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks
|
-0.457 percentage of glycosylated hemoglobin
Standard Error 0.1454
|
-0.561 percentage of glycosylated hemoglobin
Standard Error 0.1530
|
-0.428 percentage of glycosylated hemoglobin
Standard Error 0.1379
|
-0.183 percentage of glycosylated hemoglobin
Standard Error 0.1315
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned.
Change in fasting glucose following 12 weeks of therapy (that is, fasting glucose at week 12 minus fasting glucose at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.
Outcome measures
| Measure |
0.6 mg LY2189102
n=20 Participants
Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
|
18 mg LY2189102
n=15 Participants
Participants received 2 SC injections weekly for 12 weeks.
|
180 mg LY2189102
n=19 Participants
Participants received 2 SC injections weekly for 12 weeks.
|
Placebo
n=23 Participants
Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Glucose at 12 Weeks
|
-0.873 millimole per liter (mmol/L)
Standard Error 0.4802
|
-1.270 millimole per liter (mmol/L)
Standard Error 0.5299
|
-0.629 millimole per liter (mmol/L)
Standard Error 0.4591
|
-0.019 millimole per liter (mmol/L)
Standard Error 0.4404
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned.
Change in serum fasting insulin from baseline to endpoint (that is, serum insulin at week 12 minus serum insulin at week 0). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.
Outcome measures
| Measure |
0.6 mg LY2189102
n=20 Participants
Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
|
18 mg LY2189102
n=15 Participants
Participants received 2 SC injections weekly for 12 weeks.
|
180 mg LY2189102
n=19 Participants
Participants received 2 SC injections weekly for 12 weeks.
|
Placebo
n=21 Participants
Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks
|
-1.589 microinternational Units per liter
Standard Error 2.9549
|
-0.918 microinternational Units per liter
Standard Error 3.3206
|
-0.229 microinternational Units per liter
Standard Error 2.7836
|
1.405 microinternational Units per liter
Standard Error 2.8722
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Full analysis set. All randomized participants who received at least 1 dose of the study drug according to the treatment they were assigned and for whom the data are considered sufficient and interpretable. Differences in Ns are due to either dropouts and no post-baseline measure or something occurred to the sample (for example, not taken, broke).
The number of participants with a change from baseline in glucose and insulin at 2 hours after the MMTT was analyzed. The MMTT measures glucose and insulin before and after a standardized meal is eaten. Glucose and insulin levels were measured before the MMTT and 2 hours after the MMTT.
Outcome measures
| Measure |
0.6 mg LY2189102
n=22 Participants
Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
|
18 mg LY2189102
n=17 Participants
Participants received 2 SC injections weekly for 12 weeks.
|
180 mg LY2189102
n=18 Participants
Participants received 2 SC injections weekly for 12 weeks.
|
Placebo
n=24 Participants
Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks
Glucose at 2 hours
|
22 participants
|
17 participants
|
18 participants
|
24 participants
|
|
Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks
Insulin at 2 hours
|
22 participants
|
17 participants
|
18 participants
|
24 participants
|
SECONDARY outcome
Timeframe: Baseline, week 10, week 12Population: Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned.
The change from baseline in HbA1c at week 10 (that is HbA1c at week 10 minus HbA1c at baseline) and week 12 (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.
Outcome measures
| Measure |
0.6 mg LY2189102
n=21 Participants
Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
|
18 mg LY2189102
n=16 Participants
Participants received 2 SC injections weekly for 12 weeks.
|
180 mg LY2189102
n=19 Participants
Participants received 2 SC injections weekly for 12 weeks.
|
Placebo
n=23 Participants
Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12
HbA1c at Week 10
|
-0.456 percentage glycosylated hemoglobin
Standard Error 0.1459
|
-0.555 percentage glycosylated hemoglobin
Standard Error 0.1541
|
-0.413 percentage glycosylated hemoglobin
Standard Error 0.1412
|
-0.186 percentage glycosylated hemoglobin
Standard Error 0.1322
|
|
Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12
HbA1c at Week 12
|
-0.459 percentage glycosylated hemoglobin
Standard Error 0.1560
|
-0.588 percentage glycosylated hemoglobin
Standard Error 0.1712
|
-0.413 percentage glycosylated hemoglobin
Standard Error 0.1455
|
-0.192 percentage glycosylated hemoglobin
Standard Error 0.1410
|
SECONDARY outcome
Timeframe: Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dosePopulation: Full Analysis Set: All randomized participants who received at least 1 dose of the study drug according to the treatment they were assigned and for whom the data are considered sufficient and interpretable. Differences in Ns are due to either dropouts and no post-baseline measure or something occurred to the sample (for example, not taken, broke).
The Cmax value measures the maximum serum concentration and is estimated for LY2189102. The values were generated as individual estimates from a population pharmacokinetics (PK) model. Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug.
Outcome measures
| Measure |
0.6 mg LY2189102
n=18 Participants
Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
|
18 mg LY2189102
n=15 Participants
Participants received 2 SC injections weekly for 12 weeks.
|
180 mg LY2189102
n=19 Participants
Participants received 2 SC injections weekly for 12 weeks.
|
Placebo
Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks)
|
269.39 nanograms per milliliter (ng/mL)
Standard Deviation 88.23
|
6094.67 nanograms per milliliter (ng/mL)
Standard Deviation 2153.00
|
39994.74 nanograms per milliliter (ng/mL)
Standard Deviation 17880.45
|
—
|
SECONDARY outcome
Timeframe: Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dosePopulation: Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned. Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug.
Individual estimates of AUCtau at end of dosing generated from a population pharmacokinetic (PK) model.
Outcome measures
| Measure |
0.6 mg LY2189102
n=18 Participants
Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
|
18 mg LY2189102
n=15 Participants
Participants received 2 SC injections weekly for 12 weeks.
|
180 mg LY2189102
n=19 Participants
Participants received 2 SC injections weekly for 12 weeks.
|
Placebo
Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
|
|---|---|---|---|---|
|
PK: Area Under the Concentration Time Curve for Dosing Interval (Tau) at Steady State (AUCτ,SS) at End of Dosing (12 Weeks)
|
45777.78 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation 14933.09
|
986533.33 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation 340965.83
|
6555789.47 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation 2934693.46
|
—
|
SECONDARY outcome
Timeframe: Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data. Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug.
Pharmacokinetics Measured by Serum Concentration at End of Dosing.
Outcome measures
| Measure |
0.6 mg LY2189102
n=18 Participants
Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
|
18 mg LY2189102
n=15 Participants
Participants received 2 SC injections weekly for 12 weeks.
|
180 mg LY2189102
n=19 Participants
Participants received 2 SC injections weekly for 12 weeks.
|
Placebo
Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
|
|---|---|---|---|---|
|
Pharmacokinetics Measured by Serum Concentration at End of Dosing (12 Weeks)
|
252.83 nanograms per milliliter (ng/mL)
Standard Deviation 83.28
|
5532.00 nanograms per milliliter (ng/mL)
Standard Deviation 1991.28
|
35815.79 nanograms per milliliter (ng/mL)
Standard Deviation 15961.46
|
—
|
Adverse Events
0.6 mg LY2189102
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
18 mg LY2189102
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
180 mg LY2189102
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.6 mg LY2189102
n=26 participants at risk
Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
|
18 mg LY2189102
n=26 participants at risk
Participants received 2 SC injections weekly for 12 weeks.
|
180 mg LY2189102
n=27 participants at risk
Participants received 2 SC injections weekly for 12 weeks.
|
Placebo
n=27 participants at risk
Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
|
|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
0.00%
0/27
|
|
Nervous system disorders
Migraine
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/27
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
0.00%
0/27
|
Other adverse events
| Measure |
0.6 mg LY2189102
n=26 participants at risk
Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
|
18 mg LY2189102
n=26 participants at risk
Participants received 2 SC injections weekly for 12 weeks.
|
180 mg LY2189102
n=27 participants at risk
Participants received 2 SC injections weekly for 12 weeks.
|
Placebo
n=27 participants at risk
Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/26
|
0.00%
0/26
|
7.4%
2/27 • Number of events 2
|
0.00%
0/27
|
|
Cardiac disorders
Palpitations
|
7.7%
2/26 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
0.00%
0/27
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
0.00%
0/27
|
0.00%
0/27
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
2/26 • Number of events 3
|
11.5%
3/26 • Number of events 3
|
7.4%
2/27 • Number of events 2
|
11.1%
3/27 • Number of events 3
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
2/26 • Number of events 2
|
0.00%
0/26
|
0.00%
0/27
|
0.00%
0/27
|
|
Gastrointestinal disorders
Nausea
|
7.7%
2/26 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
11.1%
3/27 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
11.1%
3/27 • Number of events 3
|
|
General disorders
Injection site haematoma
|
0.00%
0/26
|
15.4%
4/26 • Number of events 4
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Injection site irritation
|
0.00%
0/26
|
11.5%
3/26 • Number of events 3
|
3.7%
1/27 • Number of events 1
|
0.00%
0/27
|
|
General disorders
Injection site pain
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
7.4%
2/27 • Number of events 2
|
0.00%
0/27
|
|
General disorders
Oedema peripheral
|
3.8%
1/26 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
7.4%
2/27 • Number of events 3
|
|
General disorders
Pyrexia
|
0.00%
0/26
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
19.2%
5/26 • Number of events 5
|
11.5%
3/26 • Number of events 3
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
3.8%
1/26 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle strain
|
7.7%
2/26 • Number of events 2
|
0.00%
0/26
|
0.00%
0/27
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
1/26 • Number of events 2
|
11.5%
3/26 • Number of events 3
|
11.1%
3/27 • Number of events 4
|
3.7%
1/27 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/27
|
7.4%
2/27 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
1/26 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
7.7%
2/26 • Number of events 2
|
0.00%
0/26
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Headache
|
3.8%
1/26 • Number of events 1
|
15.4%
4/26 • Number of events 4
|
11.1%
3/27 • Number of events 3
|
7.4%
2/27 • Number of events 2
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/26
|
0.00%
0/26
|
7.4%
2/27 • Number of events 2
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/26
|
0.00%
0/26
|
7.4%
2/27 • Number of events 2
|
0.00%
0/27
|
|
Vascular disorders
Hypertension
|
7.7%
2/26 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
7.4%
2/27 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60